Eureka Build-a-thon 2023-24

HEART-ACT

Primary Author: Alexis Beatty

TEAM LEADER

(UCSF PI Status) – Alexis Beatty

TEAM LEADER CONTACT (Email & Phone Number)

alexis.beatty@ucsf.edu 857-383-8262

TEAM MEMBERS (Teams are highly encouraged to have a non-researcher stakeholder)

Alisa Boyd

Crystal Loucel

Frances Wu

Ivan Leung

Jaya Mallidi

Niharika Dixit

Rae Oanesa

Sithu Win

Patient and Community Advisory Board

DEPARTMENT –

Epidemiology and Biostatistics

STUDY NAME –

Heart ACT

RESEARCH QUESTION -

In the pilot study phase, we aim to test a multi-disciplinary health behavior intervention in breast cancer survivors. We will recruit 50 people from Zuckerberg San Francisco General (ZSFG) who have been treated for breast cancer to participate in a pilot study of the program. We will measure the acceptability of the language-concordant program and health outcomes in participants, including change in exercise capacity, change in quality of life, change in risk factors, and adverse events.

SPECIFIC AIMS (1/2 page)

In previous work, we developed a multi-disciplinary health behavior intervention in people with a history of breast cancer to reduce heart disease risk after cancer treatment. We developed the intervention using patient- and community-engaged approaches to human-centered design. The primary aim of this research is to determine feasibility of delivering the intervention in a pilot study. Since this is a pilot study, the primary hypotheses are related to feasibility. We hypothesize that we will be able to calculate change in six-minute walk distance (6MWD) and change in quality of life (PROMIS Global Health Mental and Physical Scales) at 12 months in at least 75% of participants. We hypothesize that at least 60% of participants will complete the 12-week program. Rationale: Approximately 60% completion has been achieved in other randomized trials of cardiac rehabilitation. Secondary aims include establishing preliminary data on changes in objective and patient-reported measures including 6MWD, quality of life, health behaviors (medication adherence, physical activity, healthy eating), cognitive function, and potential mechanisms of action of the intervention including self-efficacy, social isolation, and optimism.

STUDY PROCEDURES AND TIMEPOINTS (1/2 page)

Enrollment: Month 1 to Month 12. Baseline study visit (Program Intake visit) will include a medical record review and chart abstraction for the following data: Breast cancer history, Total cholesterol, LDL, HDL, Triglycerides and date of test, Hemoglobin A1c and date of test, Echocardiogram results in the past 5 years.  At this baseline visit, participants will meet be asked to complete the following self-reported questionnaires: Demographics, Medical conditions, Tobacco/Cannabis/Alcohol use, PROMIS-Global Health, Chronic Disease Self-Efficacy, Medication adherence, PROMIS-Cognitive Function, Health literacy, Digital literacy, Hunger vital signs, International Physical Activity Questionnaire, REAP-S dietary questionnaire, PROMIS-Social Isolation, and Life Orientation Test (Optimism). At this baseline visit, participants will be asked to complete the following measurements: Blood pressure, Weight, Height, Six Minute Walk Test (6MWT). Participants will be given a Participant Results Report with these measurements. Intervention will be a 12-week multi-disciplinary health behavior program which will alternate between group and individual sessions each week.

Follow-up: Month 4 to Month 24. Patients will repeat the same questionnaires and measurements at the end of the 12-week program, at the 6-month, and 12-month follow-up visits. Patients will have a celebratory ceremony to graduate from the program in-person. For those who graduate, an exit interview will be conducted for feedback on the intervention and used to improve the following sessions.

FEASIBILITY (1 paragraph) – Please comment on the feasibility of using Eureka for this study and feasibility of executing the study once built.

This study will include the collection of survey data and device data (FitBit), which can be accomplished through Eureka. The Eureka platform will serve as the study data collection platform for a study that is anticipated to start Fall 2024 (initial IRB review has occurred; we are answering final stipulations prior to approval).

FUNDABILITY (1 paragraph) – What is your current funding for this project, or if currently unfunded, how will this support funding applications?

This project is fully funded by a gift to the University. After completing the pilot study, the data will be used as preliminary data to apply for grants to support a multi-center randomized trial of the intervention.

PROFESSIONAL DEVELOPMENT (1 paragraph) – How will this project support the professional development of the team leader and/or team members?

This project will contribute to the professional development of a multi-disciplinary team, including two nurse clinicians and a clinical research coordinator, who collectively identify as BIPOC women driven by a shared passion for advancing their research careers. Through active engagement in the project's multidisciplinary research initiatives, they'll gain exposure to new methodologies, collaborate with experienced researchers, and contribute to generating insights in the field. This immersive experience will not only amplify their technical adeptness but also foster a network of peers and mentors. By harmonizing efforts with diverse experts and making meaningful contributions to innovative research outcomes, both team leader and members will authentically broaden their connections, grow their technological skills, access invaluable mentorship, and fortify their journey towards impactful research careers.

IMPACT (1 paragraph) – What improvements will result if your research succeeds (e.g., what are the public health implications or community benefits)?

If this research succeeds, it will bring about improvements with far-reaching public health implications for breast cancer survivors. Firstly, the successful implementation of the multi-disciplinary health behavior intervention among breast cancer survivors will pave the way for enhanced offering of tailored, patient-centered cardiac rehabilitation programs. These programs will be more accessible, catering to a diverse range of individuals, including women, individuals from racial/ethnic minority backgrounds, and those with lower socioeconomic status. By integrating telehealth technology, fitness wearables like FitBit, and personalized exercise equipment, the intervention will empower healthcare organizations to address barriers to cost, attendance and participation. As a result, individuals who might have previously faced challenges accessing cardiac rehabilitation due to factors like program design, health literacy, and accessibility will now have a more tailored and engaging pathway to improving their heart health. This research success will not only contribute to individual well-being but also generate ripple effects in communities, leading to reduced cardiovascular disease risk and improved overall health outcomes.

 

BronchConnect

Proposal Status: 

TEAM LEADER:
B. Shoshana Zha, MD PhD

TEAM LEADER CONTACT:
shoshana.zha@ucsf.edu, #540-454-2779

TEAM MEMBERS:
Natalie Stumpf, MD, PGY-2
Jeff Tarnow, RCP—role: construction of form of the intervention
Vickie Jue, Pharm D—role: construction of form of the intervention
Isabella Cheng—role: construction of form of the intervention

DEPARTMENT:
Medicine, Division of Pulmonary, Critical Care, Allergy and Sleep Medicine

STUDY NAME
Impact of Patient Support Groups on Quality of Life in Patients with Non-Cystic Fibrosis Bronchiectasis (BronchConnect)

RESEARCH QUESTION
What impact does participation in a patient support group have on health care quality of life for patients living with non-cystic fibrosis bronchiectasis?

SPECIFIC AIMS
Bronchiectasis is a chronic disease marked by abnormally dilated and inflamed airways, resulting in chronic cough, recurrent infections, and even respiratory failure1,2. Noncystic fibrosis bronchiectasis (NCFBE) can stem from a variety of causes outside of cystic fibrosis, including ciliary dysfunction, autoimmune disorders, gastroesophageal reflux, and other mechanisms not yet fully understood3,4. Regardless of the underlying etiology, the focus of treatment is to inhibit a vicious cycle of infection, inflammation, mucus impaction, and worsening airway dilation 5 through aggressive airway clearance techniques and often repeated prolonged courses of antibiotics6,7. Acute bronchiectasis exacerbations can occur and cause progression of disease8. Moreover, a significant increase of NCFBE in the last few decades, up to 700 per 100,000 in those greater than age 65 in the United States9, combined with the chronic consequences of disease, has resulted in a large economic impact10. Both the disease manifestations and the treatments involved can have a significant impact on the quality of life for patients living with bronchiectasis. Chronic cough is embarrassing, limiting ventures outside the home, hours of airway clearance limits productivity, and fear of the unknown of the next infection and little understanding of the natural history of disease results in anxiety11,12. Patient support groups have been shown to improve understanding of disease, decrease anxiety, and build a sense of community in multiple chronic lung diseases such as chronic obstructive pulmonary disease (COPD)13 and pulmonary fibrosis14. However, there is no published study on the effect of support groups in NCFBE. We hypothesize participation of an accessible patient support group will improve quality of life in those living with NCFBE in the San Francisco Bay Area.  To study this, we will address the following aims:
AIM 1: Elucidate if an accessible patient support group improves health care quality of life in patients with NCFBE by tracking participation and validated survey responses of participants over time.
AIM 2: Determine if participation in a patient support group reduces bronchiectasis exacerbation rates in those living with NCFBE in the San Francisco Bay Area.

STUDY PROCEDURES AND TIMEPOINTS
BronchConnect is a prospective cohort study of NCFBE patients who receive care at UCSF and seek participation in a patient support group using a repeated measures design.

Study Subjects: While the target population is all persons with bronchiectasis in the San Francisco Bay Area, those accessible to this study are only those who receive medical care at UCSF. We will restrict the population according to the following criteria:

  • Inclusion:
    •  >18 years of age
    • Diagnosis of NCFBE as confirmed by chest CT, ≥2 ICD 9 or 10 codes for bronchiectasis or bronchiectasis exacerbation (J47*, 494*, Q89.3, 759.3), and referring physician assessment
  • Exclusion:
    • Inability to provide informed consent
    • Inability to complete questionnaires independently
    • HIV positivity
    • Solid-organ transplant
    • Cystic fibrosis

Sample Size:
Our initial work will pilot the intervention of support group and method of metrics. We aim to enroll a minimum of 30 participants. With a proportion of positive results estimated at 0.33 based from previous studies15 and a confidence level of 95%, we can assert that the proportion of improvement of both symptoms and exacerbation rates would be situated between 22.6 and 59.4%16.
Approach: Potential participants will be referred from UCSF’s Lung Health Center. Medical records will be briefly reviewed for inclusion and exclusion criteria prior to participants approached for introduction and informed consent. In addition, HIPAA will be reviewed with each potential participant given the nature of the intervention in a shared space. After informed consent, participants will complete a questionnaire that is combined for both valid questions on bronchiectasis health care quality of life and symptoms, as well as novel questions to address the role of the support group in terms of most useful topics, understanding of treatments, and reasons for attending sessions (or not attending). Medical records will be reviewed to quantify number of bronchiectasis exacerbations in the previous 1 year, most recent pulmonary function tests (PFTs), chest CT interpretation, comorbidities and current medications.
The patient support group will meet over Zoom monthly. Sessions will be a mix of featured speakers presenting on topics of relevance to the community (such as new research, supplemental oxygen, pulmonary rehab, understanding the underlying mechanisms of bronchiectasis, airway clearance techniques) as well as open forums for patients to discuss their experiences. Questionnaires will be repeated at 3, 6, and 12 months after initiation of the support group. Further, at 12 months, the medical record will be re-reviewed for PFT trend, bronchiectasis exacerbation rate, medications, and hospital encounters.

FEASIBILITY
BronchConnect is a feasible study from multiple perspectives. First, a subspecialty clinic for NCFBE patients exists within the Lung Health Center, providing the opportunity to obtain the sample size and prospective method proposed. Second, 2 other sustained patient support groups exist at the Lung Health Center (Cystic Fibrosis and Interstitial Lung Disease) providing a foundation of best practices. Third, the key stakeholders from team members in the clinic, patients, and family have voiced desire for this intervention to be implemented. Lastly, Dr. Natalie Sumpf is committed to the initiation and sustainability of this project for the patients and career development. Using Eureka would make this study further feasible because of the survey-based nature of the project. Eureka would make it easier to build the survey in a HIPAA-compliant manner, send patients survey reminders, and to enable survey participation, especially since the patient support group will be hosted virtually over Zoom and participants will less commonly be seen face to face during these time periods. Further, potential expansion of the study aims if Eureka is implemented could occur, including tracking pulse oximeter data to assess participants’ oxygen levels, heart rate to assess activity abilities over time, and cough monitors for assessment of changes in exacerbation risks and objective data of symptom control.

FUNDABILITY
This project is currently funded by a Nina Ireland and generous donation. By increasing our capacity in this project through Eureka, the data will be used to apply for funding through foundation grants with an ultimate aim of a multicenter randomized control trial that would be proposed for R level funding.

PROFESSIONAL DEVELOPMENT
Natalie Stumpf is a current second year Internal Medicine resident in pursuit of a career in clinical research and pulmonology. This project is her independent development and her first independent work. This project will be conducted in parallel to further class work and mentorship to further her short-term goals of learning mechanisms of research. It will provide a foundational opportunity to learn the fundamentals of project development, implementation, and data analysis, which will establish a groundwork for her long-term career goals including pulmonary fellowship and academic medicine. The opportunity to use research tools such as Eureka would not only make the project more feasible as outlined above, but also form a cornerstone part of the educational experience.

IMPACT
Patients currently receiving care at the Lung Health Center are requesting a patient support group. In addition, we are aware of similar requests through online forums and at international meetings where patient representatives participate. We believe patient support groups would have a significant impact on patients’ journeys to understanding and controlling symptoms of their condition. The overall goal of our work is to enable patients to live better with NCFBE through understanding their condition and having more control over management. Being able to study the impact of participation via qualitative and objective findings would provide evidence to initiate such groups throughout the country.

 

REFERENCES

1.        Dupont M, Gacouin A. Survival of Patients With Bronchiectasis After the First ICU Stay for Respiratory Failure *. Published online 2004:1815-1820. doi:10.1378/chest.125.5.1815

2.        Keir HR, Chalmers JD. Pathophysiology of Bronchiectasis. Semin Respir Crit Care Med. 2021;42(4):499-512. doi:10.1055/s-0041-1730891

3.        Aksamit TR, O’Donnell AE, Barker A, et al. Adult Patients With Bronchiectasis A First Look at the US Bronchiectasis Research Registry. Chest. 2017;151:982-992. doi:10.1016/j.chest.2016.10.055

4.        Chandrasekaran R, Mac Aogáin M, Chalmers JD, Elborn SJ, Chotirmall SH. Geographic variation in the aetiology, epidemiology and microbiology of bronchiectasis. BMC Pulm Med. 2018;18(1). doi:10.1186/s12890-018-0638-0

5.        Cole PJ. Inflammation: A Two-Edged Sword-the Model of Bronchiectasis.; 1986.

6.        Hill AT, Sullivan AL, Chalmers JD, et al. British thoracic society guideline for bronchiectasis in adults. Thorax. 2019;74. doi:10.1136/thoraxjnl-2018-212463

7.         Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. PMID: 28596426.

8.        Polverino E, Goeminne PC, McDonnell MJ, et al. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017;50:1700629. doi:10.1183/13993003.00629-2017

9.        Henkle E, Chan B, Curtis JR, Aksamit TR, Daley CL, Winthrop KL. Characteristics and Health-care Utilization History of Patients With Bronchiectasis in US Medicare Enrollees With Prescription Drug Plans, 2006 to 2014. Chest. 2018;154(6):1311-1320. doi:10.1016/j.chest.2018.07.014

10.      Goeminne PC, Hernandez F, Diel R, et al. The economic burden of bronchiectasis - Known and unknown: A systematic review. BMC Pulm Med. 2019;19(1). doi:10.1186/s12890-019-0818-6

11.      Lavery K, O’Nelll B, Elsborn JS, Relly J, Bradley JM. Self-management in bronchietasis: The patient’s perspective. Eur Respir J. 2007;29(3):541-547. doi:10.1183/09031936.00057306

12.      Delestre-Levai I, Aliberti S, Almagro M, et al. Patients’ perspectives on bronchiectasis: findings from a social media listening study. ERJ Open Res. 2021;7(3). doi:10.1183/23120541.00096-2021

13.      Lenferink A, van der Palen J, Effing T. The role of social support in improving chronic obstructive pulmonary disease self-management. Expert Rev Respir Med. 2018;12(8):623-626. doi:10.1080/17476348.2018.1489723

14.      Van Manen MJG, Geelhoed JJM, Tak NC, Wijsenbeek MS. Optimizing quality of life in patients with idiopathic pulmonary fibrosis. Ther Adv Respir Dis. 2017;11(3):157-169. doi:10.1177/1753465816686743

15.      Alcazar B, Lucas P De, Soriano JB, et al. The evaluation of a remote support program on quality of life and evolution of disease in COPD patients with frequent exacerbations. BMC Pulm Med. Published online 2016:1-12. doi:10.1186/s12890-016-0304-3

16.      Kohn MA U of CSF, Senyak J U of CSF. Sample Size Calculators. Published 2021. https://sample-size.net

Supporting Documents: 

Health and Life Study of Afghan Refugees in California, Using an online RDS platform

  • TEAM LEADER Ali Mirzazadeh MD MPD PhD, Associate Professor of Epidemiology and Biostatistics, University of California San Francisco.
  • TEAM LEADER CONTACT Ali.Mirzazadeh@ucsf.edu - 4158664234
  • TEAM MEMBERS

1-    Seyed Sina Neshat MD, Postdoc Researcher, Department of Epidemiology and Biostatistics, University of California San Francisco.

2-    Sima Naderi, MPH, MS, PhD Student, Global Health Science, University of California San Francisco.

3-    Eva Raphael, MD, MPH Assistant Professor in Epidemiology and Biostatistics

4-    Carol Camlin, MPH, PhD Professor of Ob/Gyn

5-    Mohammad Sediq Hazratzai, MD, MPH Afghan senior scientist who is a global affiliated faculty at IGHS

6-    Asiya Yama – Non-researcher community member

  • DEPARTMENT
    Epidemiology and Biostatistics
  • STUDY Name
    Health and Life Study of Afghan Refugees in California
  • RESEARCH QUESTION
    What is the Health and Life vulnerabilities of Afghan Refugees in California? 
  • SPECIFIC AIMS (1/2 page)

 

Study to Monitor Health and Life Vulnerabilities of Afghan Refugees

 

Objective:

To monitor the health, socio-demographic, and life vulnerabilities of recently settled Afghan refugees in the Sacramento area through a phone or web-based respondent-driven sampling (RDS) survey and in-depth interviews.

 

1. Cohort Study Development and Pilot-testing:

 

Population: 50 Afghan households (~100 individuals) recently settled in Sacramento.

 

Methodology:

 

Phone or web-based RDS survey.

Measurement of socio-demographic, life, and health vulnerabilities.

Examination of past and ongoing first or second-hand exposure to conflict.

Duration: 6 months follow-up.

 

Data Collection Tools and Outcomes:

 

Individual Surveys:

Physical and Mental Health [Short-Form/SF-8]

Postmigration Living Difficulties Checklist [PMLD]

The Refugee Health Screener-15 [RHS-15]

Ken Miller’s Afghan Symptom Checklist [ASCL]

Health Outcomes (via electronic medical records and self-report):

Risk factors

Infectious disease (TB, COVID-19)

Drug-resistant infections

Vaccinations

Maternal and reproductive health

Self-report on access to and use of available services.

2. Exploration of Afghan Refugee Experiences:

 

Objective: To understand the experiences, attitudes, and causes of vulnerabilities among Afghan refugees.

 

Methodology:

 

In-depth Interviews:

Men: 10 (5 with the lowest RHS-15 scores and 5 with the highest)

Women: 10 (5 with the lowest RHS-15 scores and 5 with the highest)

Focus Group Discussions:

Caseworkers: 2 groups (n=10 each)

Focus:

 

Assess gaps in the refugee resettlement program.

Refine the content and process of the program based on insights from the focus group discussions.

  • STUDY PROCEDURES AND TIMEPOINTS (1/2 page)

Approaches to Aim 1 - Develop and pilot-test a cohort study to monitor health and life vulnerabilities of Afghan refugees.

Formative assessment and advocacy meetings. The formative assessment includes activities for the preparation of the study, community engagement, and advocacy meetings to foster a supportive environment for the study. The formative assessment will be conducted in the Sacramento areas with the highest density of Afghan refugees (including Arden Arcade, Rancho Cordova, Elk Grove, and West Sacramento) to assess the characteristics of Afghan refugee populations, the feasibility and acceptability of study methods, and to provide information to tailor RDS methods and logistic approaches to the different Afghan refugee populations and their social contexts. This phase will last about two months.

Participants of the study will be recruited using RDS methods. RDS requires a formative assessment [6, 7] to verify theoretical requirements, understand social network connections, and gather information to inform implementation logistics. The characteristics of Afghan’s social networks also need to be understood to ensure the appropriate number and type of “seeds” (i.e., initial participants who generate peer referral chains from their social circles) are selected, to identify potential “bottlenecks” (i.e., social and physical barriers between networks), and to define variables needed to track “equilibrium” (i.e., when stability in the sample is achieved on key characteristics). This theoretical and logistical information for RDS will be acquired through in-depth key informant interviews. Individuals are eligible for the formative assessment if they a) are aged 18 years and older, b) are members of Afghan refugee community or worked with them as first-hand experience, and c) have lived in the Sacramento area for at least six months.

Key informant interviews. Persons with first-hand information about Afghan refugees, their needs, and best strategies to approach and recruit them to the survey include Afghan refugees themselves and local NGO managers and health authorities who work with or provide services to Afghan refugees. These include community-based organizations, mosques (Aisha, Salaam, and Tawheed mosques), the Office of Refugee Health, California Department of Public Health, and resettlement agencies such as International Rescue Committee and Opening Doors. Such persons are considered key informants (KI) and will be interviewed individually to seek their insights on the questions listed in the Key Informant Interview (KII) guide. We will ensure that key informants include women and members of other groups of Afghan refugees who have historically been difficult to recruit (e.g., Hazara, LGBTQ+).

Key informant interviews procedures. A minimum of 20 key informant interviews will be conducted. KIIs will continue until saturation has been reached; that is, the point at which additional interviews fail to provide new information about the neighborhoods/locations, social structure, groups, and organizations of areas where recently Afghan refugee households settled in the Sacramento area. Our research team will reach out to local NGOs, key service providers, and stakeholders for referrals of people who can serve as key informants. Eligible key informants will be asked to come to the study site where KIIs will be conducted in a private conference room for 1-2 hours. Participants will be provided a meal (if allowed by COVID-19 restrictions) and reimbursement for their travel expenses. Staff trained in interview skill will conduct the KII following a semi- structured interview guide. An introduction will be followed by easy questions to put participants at ease. After each KII is completed, the KII interviewer will review answers, write up the field notes, and note emerging themes to be used in the analysis. Each enrolled KII will be reimbursed ~$20 for participating. The exact amount will be determined by the formative assessment.

Analysis of key informant interview data. We will analyze the data from the KII and discuss primary findings related to RDS theory and logistics, and strategies to improve the survey. For example, if social networks appear too weak or diffuse, the investigators will develop a plan for recruiting additional seeds and alternate strategies for enhancing recruitment based on findings and within a theoretical, probability-based sampling framework. The survey protocol and Standard Operating Procedures (SOPs) will be updated based on findings from the formative assessment. A list of modifications in addition to the revised survey documents will be submitted to the Ethical Review Board for review and approval.

Pilot of the survey questionnaire. Once the survey instrument is finalized, it will be piloted among 5 Afghan refugee households referred by local NGOs; a trained interviewer will individually interview participants referred and administer the questionnaire over phone call or in-person in a private office. Each enrolled individual will be reimbursed the equivalent of ~$20 for participating. Following the questionnaire administration, participants will meet local investigators and be asked for feedback on the interview and survey process. Participants will be asked for recommendations on improving the instrument and specifically on the clarity of questions, re- framing of items, the acceptability of time to complete the survey, and identify terms and constructs that may be missing or are culturally incongruent.

Advocacy meetings. In many settings, refugee populations are subject to stigma and discrimination; it is, therefore, critical to hold advocacy meetings with local health care providers, local authorities, and other key stakeholders prior to starting the survey. Involving key stakeholders from the start will encourage communication and foster a supportive environment for the study. The study core team, research assistants and peers attend gatherings (i.e., after prayer services) to talk about the study. The advocacy meetings will outline the objectives and benefits of the study to participants and emphasize the importance of facilitating refugee population’s access to the survey site.

Sampling method. The study will utilize Respondent Driven Sampling (RDS) to achieve the target samples (N=50 households). The sampling process in this method begins with selecting a small number of recently settled Afghan refugees who have been purposefully selected from the target population. In this method, each primary participant, called a “seed”, is asked to invite a limited number of their peers in the refugee population to participate in the study. Seeds are people who are known among the Afghan refugee populations. A total of 2-3 seeds will be considered. Those peers who successfully participate in the study repeat the process of inviting and referring peers to the study until the sample size reaches the desired number. The participants receive primary and secondary incentives for their own participation in the study and successful referral of peers to the study, respectively. Inviting and referring peers to study is managed using a coupon numbering system. In this study, a maximum of 3 coupons are given to each seed or enrolled participant, so we can reach relatively long sampling chains to avoid bias from the initial seed selection. Recruitment diagnostics will be run weekly to assure that the recruitment is reaching through diverse networks. Additional seeds may be identified and launched as needed.

Enrollment. Enrolled seeds will receive 3 electronic (via email, text message, or WhatsApp app which is popular among Afghans) or paper coupons that include an introductory note on the study, the study phone contact, the study URL (https://www.sehatinitiative.org) and a unique number. Peers who receive a coupon and are interested in participating in the study can call the study team or use the URL to submit a short form using a unique number. Once one of our staff determines their eligibility over a phone call, they will be briefed and upon providing consent, will be enrolled to the study. Anyone enrolled in the study will be asked to also invite and refer any partners they may have in their household to the study. Those who are single will be enrolled as single individuals. Non-seeds follow the same protocols to invite and refer their peers and their partner in their household to the study.

Measurements. All materials (coupons, forms, surveys, questionnaire, study website) will be prepared in English, Dari, and Pashto. The study survey includes sections to collect data for socio-demographic, life and health vulnerabilities (including Physical and Mental Health [Short-Form/SF-8], Postmigration Living Difficulties Checklist [PMLD], The Refugee Health Screener –15 [RHS-15], Ken Miller’s Afghan Symptom Checklist [ASCL]), and a checklist of the first or second-hand experienced conflicts.

  • Socio-demographic: sex, age, education, current and past income, past housing status, current housing status and housing insecurity, current and past occupation, access to and use of California’s Refugee Cash Assistance, food insecurity, current and past marital status, family size, immediate family in Afghanistan, months outside of Afghanistan, months in US.
  • Physical and Mental Health [Short-Form/SF-8]: the SF-8 developed by Quality Metric [8], include 8 questions (General health, Physical functioning, Role – physical, Bodily pain, Vitality, Social functioning, Role – emotional, Mental health) each has five response category (1 to 5) and can be administrated in 2 minutes. The questions have a 4-week recall period and can measure both physical and mental health components. The principal component analysis of SF-8 among conflict-affected people [9] showed two physical (r>0.7) and mental (r>0.7) construct validity, high test-retest reliability (r=0.68).
  • Postmigration Living Difficulties Checklist [PMLD]: PMLD checklist [10] include 23 questions each with five-point Likert scale response that measures the severity of pre and post migration common problems experience by asylum seeker within the past 12-month timeframe. The principal component analysis of PMLD among Afghan refugees in Istanbul [11] showed five constructs (conditions of extreme precarity, asylum difficulties, employment-related problems, access to medical and social services, marginalization and family-related stressors) with Cronbach’s alpha from 0.719 to 0.891.
  • The Refugee Health Screener –15 [RHS-15]: The RHS-15 is a screening tool for common mental disorders in refugee populations. It can be self- or provider-administrated which takes about 4 to 12 minutes to complete. A study of refugees from three different countries [12] showed a very high internal consistency with Cronbach’s alpha 0.92 for questions 1 to 15. With cutoff 12, it has positive and negative predictive values range from 0.78 to 0.98 for PTSD, anxiety, and depression.
  • Ken Miller’s Afghan Symptom Checklist [ASCL]: the ASCL is a 22-item tool [13] to identify the severity of distress among Afghan. It has excellent reliability (Cronbach’s alpha 0.93) and good construct validity, and its score highly correlated with measures of exposure to war-related violence and loss (r=0.70).
  • Conflicts checklist: We aim to understand the ways in which violent conflict and exposure to trauma in Afghanistan and ongoing since immigration affects individuals and households along key social and economic dimensions. Since no validated survey exists for this population, we will modify and contextualize the World Bank Conflict Exposure Survey [14] to collect data on direct and indirect conflict exposure while in Afghanistan, ongoing exposure to conflict-related trauma since immigration and secondary conflict- related trauma exposure as part of the local Afghan community in Sacramento and ‘back home’. The World Bank Conflict Exposure Survey will be supplemented by additional components based on literature review of previous research from war-affected countries [15-19] as well as community trauma exposure [20] and micro/personal trauma exposure survey questions [21].

Based on the participant's choice, we will collect data using an online survey, or interview them over phone calls, WhatsApp call, in-person, or Zoom in their mother language (Dari or Pashto). The above measures will be assessed at baseline visit among enrolled individuals. The enrolled individuals will have a follow-up visit at six months to measure changes in the above vulnerability outcomes. Further data will be collected for enrolled households who provide consent to link their survey data to their medical record data. The medical records data of each household member who consents will be obtained to ascertain the presence of medical conditions and preventative screening. We will obtain data transfer agreements and work with healthcare systems (e.g., Sutter, UC care, etc.) to extract identified electronic medical record data from structured data fields. We will base analyses on the presence of International Classification of Diseases (ICD) codes in problem lists and vaccination records. Specific conditions we will assess include several health indicators such as infectious disease (latent TB [22], COVID-19, drug-resistant infections [23]), vaccinations, and other maternal and reproductive health conditions. Medical records data will be stored in a university-managed, firewall-protected secure data service, and linked to questionnaire data to create a rich database of self-reported information on experiences and clinical data based on medical screenings. We will also link our survey data to Refugee Health Electronic Information System (RHEIS) which collects Refugee Medical Screening (RMS) data including screening data for chronic conditions and infectious disease, and screening for mental health on arrival. UCSF Co-investigator, Dr. Eva Raphael (Family Physician and Clinical Researcher) will lead medical records linkage and extraction, as she has robust experience obtaining data from various healthcare systems.

Retention strategies. While our study is a pilot to build the cohort and find best enrollment and retention strategies, we have several strategies in place including use of electronic messaging, WhatsApp, contact through enrolled household partners, progressive monetary incentives ($20 for baseline visit and $30 for follow-up visit), and social advocacy gathering among communities and outreach programs to maximize retention and re-contact with those who dropped out or missed a visit.

Sample size justification. Our study is a pilot study that is not powered to estimate (rare) outcomes precisely. However, this small study will enable us to assess the feasibility and acceptability of our methods. We calculated the sample size with the following assumptions:

  • Population size (for finite population correction factor), N: 20,000 [24]
  • Hypothesized % frequency of outcome (unknow; 50% leads to the maximum n), p: 50%
  • Confidence limits as % of 100 (absolute +/- %), d: 14%
  • Design effect (for RDS household surveys), DEFF: 2 [25]

Sample size n = DEFF x [Np(1-p)]/ [(d2/Z21-α/2*(N-1)+p*(1-p)] = 98 (we will recruit 100 individuals from 50 households)

Analysis: We will record the frequencies of the total number of eligible refugees who were asked to participate, the number who accept, the number who decline, and the reasons for not wanting to participate. This allows us to calculate the acceptance rate and accrual. For the response rate, we will assess the completeness of answers to key questions at baseline and each follow-up visit. For other study outcomes (measurements of life and health vulnerabilities), we report both crude and RDS-adjusted estimates. For RDS- adjusted estimates which consider network size and homophily within networks, we will use the RDS package in R software [26] and Gile’s successive sampling estimator [27] to produce weighted average or prevalence estimates. We will use R 4.2.1 [28], and STATA v.17 [29] for data analysis.

Approaches to Aim 2 - Explore the experiences, attitudes, and causes of vulnerabilities of Afghan refugees.
We will conduct in-depth interview with men (n=5 and 5) and women (n=5 and 5) participants in the cohort study (Aim 1) who have the lowest and highest RHS-15 scores in their last visit and run four focus group discussions (FGD) among caseworkers (n=10). Each person will receive ~$20 for their time and cost of their participation.

Data collection: Data collection will be done over phone calls, WhatsApp call, in person, or Zoom meeting. A guide will be used to probe: 1) questions and concerns regarding their income, livelihood, and health issues 2) identifying circumstances in which respondents feel unbearable stress or burn out, 3) type of conflicts, either

direct or indirect, they have experienced in the past or are ongoing that are affecting their wellbeing, 4) successful strategies that help them reduce their vulnerabilities, and 5) interventions to address the causes of vulnerabilities.

Qualitative analysis: Our trained staff will take notes and audio record conversations in the in-depth interviews and focus group discussions. After each focus group, the study team will meet to discuss notes and produce a detailed report for each discussion using the notes and audio recordings. Led by Dr. Camin, an iterative qualitative data analysis process will be conducted. A framework analysis will be used for the interpretation of the data. The thematic analysis method will apply to analyze the data. Transcripted and transcribed data will be analyzed based on pre-defined themes (such as livelihood, stressors, conflicts, strategies, and interventions) by Dedoose software. Data will be shared with the CDPH office of refugee to assess the gaps and further refine the content and process of the refugee resettlement program.

Timepoints: Preparation and community engagement (2 months), RDS enrollment and cohort follow-up (9 months), Qualitative study (2 months), Dissemination (1 months).

  • FEASIBILITY (1 paragraph) – The Eureka platform, with its integrative design for mobile research, offers a highly feasible environment for our project that seeks to monitor the life and health vulnerabilities of Afghan refugees post-resettlement. The majority of refugees, especially the younger population, have access to mobile devices, making a phone/web-based respondent driven sampling (RDS) survey not just doable but efficient. The platform's secure backend ensures the confidentiality and safety of sensitive information, which is paramount in studies involving vulnerable populations like refugees. Moreover, Eureka's participant-engaging front-end can enhance the user experience, promoting consistent engagement from our target cohort. Once the study is built on Eureka, its study management portal facilitates timely follow-ups, efficient data collection, and seamless linkage to electronic medical records. The inherent challenges of working with a refugee population, such as trust-building and cultural sensitivities, can be ameliorated with proper training of on-ground staff and tailoring the app interface to be culturally appropriate. In essence, using Eureka not only makes the execution of our study feasible but also streamlines the data collection and analysis processes, enhancing the overall quality and efficiency of our research endeavor.
  • FUNDABILITY (1 paragraph) – What is your current funding for this project, or if currently unfunded, how will this support funding applications?

Although our study is already funded through the UCSF RAP grant, participating in the Build-a-thon offers the chance to broaden our research scope and collaborate on a basic Eureka study. The opportunity to win complimentary Eureka maintenance for a year and access discounted rates for maintenance fees is appealing, as it can facilitate recruitment and enhance our data analysis capabilities. Engagement in such initiatives reflects our proactive approach and dedication to maximizing our research's impact, which can positively influence potential future funding applications.

  • PROFESSIONAL DEVELOPMENT (1 paragraph) – How will this project support the professional development of the team leader and/or team members?

The study will enable us to design and pilot-test methods to assess the life and health vulnerabilities of Afghan refugees during the early post-resettlement period. The formative assessment, the RDS and cohort phases, and the qualitative research parts will be managed by the faculty of three UC campuses, which will foster cross-campus collaborations for the project PI and other co-investigators. Building on our previously established local and state-wide refugee health networks, this project will be the first attempt to document vulnerabilities in newly resettled Afghan refugees in California. We trust that this pilot will open several opportunities for future grant applications to study the health and life vulnerabilities of thousands of Afghan refugees. Our screening data for health and life vulnerabilities will be valuable to plan for future interventions, such as a SHINE nature-based intervention that one of our Iranian scientists at UCSF has developed to reduce stress among low-income families.

  • IMPACT (1 paragraph) – What improvements will result if your research succeeds (e.g., what are the public health implications or community benefits)?

The study finding could indeed be very useful in evaluating continuity of care and health outcomes and vulnerabilities post Refugee Medical Screening (RMS) which 11 counties in California are funded by the government to provide such screening. CA programs follow CDC recommendations for screening and medical exams for Afghan refugees during the initial resettlement period. However, post resettlement health and life outcomes would be valuable to assess. It is the gap that our study addresses. We have engaged the CDPH team and stakeholders to ensure findings are being used for system improvement, to assess the gaps, and further refine the content and process of the refugee resettlement program.

 

 

Living With Meningioma

Proposal Status: 

 

    • TEAM LEADER (UCSF PI Status):
      • William C Chen MD
    • TEAM LEADER CONTACT (Email & Phone Number):
    • TEAM MEMBERS (Teams are highly encouraged to have a non-researcher stakeholder)
      • William C Chen MD
      • David R Raleigh MD PhD
      • John de Groot MD
      • Steve Braunstein MD PhD
      • Minh Nguyen BS
      • Nicole Willmarth PhD (Patient advocate and Chief Mission Officer, American Brain Tumor Association)
    • DEPARTMENT
      • Radiation Oncology and Neurosurgery
  • RESEARCH QUESTION

We aim to leverage the unique Eureka platform to reach a broad population of meningioma survivors and enroll them into our Living With Meningioma cohort. We will perform annual questionnaires investigating quality of life, symptom burden, engagement with and barriers to care, and lasting effects of treatment for this common tumor, over a study period of 5 years. We will also recruit normal control participants as a control arm as comparison.

  • SPECIFIC AIMS (1/2 page)

Meningioma is the most common primary intracranial neoplasm, accounting for approximately 40% of newly diagnosed primary brain tumors and with approximately 42,000 new cases annually in the United States1. The estimated prevalence of persons living with meningioma in the United States is between 170,000 and 210,000, although this number may be much higher, up to 400,000 or more, based upon incidence and survival rates2. The primary treatment of meningioma includes surgical resection and/or ionizing radiation therapy, as systemic therapies remain ineffective or experimental. Most WHO grade 1 meningiomas can be effectively treated with surgery or radiotherapy, but many WHO grade 2 or grade 3 meningiomas are resistant to treatment and cause significant neurological morbidity and mortality3. With appropriate treatment and surveillance, however, most meningioma patients have a long survival horizon, with a 10-year relative survival of approximately 83-87% compared to age-matched normal controls1. Yet, despite being the most common primary brain tumor, there exists minimal data on the long-term quality of life, side effects of therapy, and survivorship considerations for patients living with meningioma. The scant existing literature4 indicate that survivors living with meningioma experience lasting symptoms of disease and effects of treatment, long after diagnosis and therapy, and also experience gaps in communication and information about their disease process and access to survivorship resources. In particular, little to no data is available to guide providers, patients, and caregivers, about the long-term risks and impacts of intracranial radiation therapy for meningioma5. The aim of this proposed study is to leverage the unique Eureka platform to engage a broad target population of persons living with meningioma, initially in California but eventually nationwide, in order to begin to study and improve our understanding the long-term impacts of this disease and its treatment on the lives and well-being of meningioma survivors.

  • STUDY PROCEDURES AND TIMEPOINTS (1/2 page)

Living With Meningioma will prospectively enroll participants with a self-reported diagnosis of meningioma, at any timepoint of their treatment and survivorship journey and will follow them longitudinally for a period of 5 years. Initially, the target population is all adult persons age 18 or older with a diagnosis of meningioma residing in the state of California. In the interest of capturing as broad a target population as possible, we will utilize self-report of a meningioma diagnosis, given the difficulty of obtaining detailed medical records for persons throughout California who may have been treated many years ago at non-UCSF medical centers with varying medical record systems. Exclusion criteria include the inability to provide informed consent and the inability to interact with the Eureka platform to successfully complete the study questionnaires. Potential participants will be identified via mailing lists, listservs and contact information of brain tumor survivors available through the American Brain Tumor Society, as well as through lists of meningioma patients treated at UCSF. In the future, as the study expands, we will seek out brain tumor survivorship groups in major metropolitan centers, seek out participation from collaborators at other medical centers, and also utilize social media messaging and ads in order to identify more participants. Prospective participants meeting eligibility will be initially screened by self-report of a diagnosis of meningioma at any time in their life. We will initially target a pilot sample size of 250 participants recruited within then 1st year of the study, but eventually will expand to a target of 2,500 participants, or ~0.5%-1% of meningioma survivors in the United States. An incentive of $10 will be offered for completion of each set of annual surveys.

Simultaneous to recruiting of meningioma survivors as above, we will seek to recruit control participants of similar age and characteristics in a 2:1 ratio favoring meningioma survivors, using the method of recruitment by referral of friends and family members. 50% of meningioma survivors enrolled in the study will be asked to identify a friend or family member of similar age without a known meningioma diagnosis, to themselves to be enrolled in Living With Meningioma as a control subject; the number of meningioma survivor participants asked to refer a friend/family member can be uptitrated depending upon the successful referral and enrollment rate of normal controls. An incentive of $10 will be offered for completion of each set of annual surveys, and a referral incentive of $5 for successful referral of a normal control.

The following questionnaires will be performed for meningioma survivors: a modified meningioma specific version of the FOCUS (Follow Up Care Among Survivors) survey6 which is an established survey for cancer survivors collecting comprehensive data on symptom burden, cancer history, treatment, and follow up, second cancers, and quality of life. The questions will be modified to be meningioma specific and the questionnaire shortened. The EORTC QLQ-C30, Meningioma-specific quality of life (MQOL)7, and BN20 (brain specific) quality of life questionnaires will be administered, along with the COST-FACIT financial toxicity survey, and Decision Regret Scale (if patients have undergone a treatment); each of these are 1 page long and fast to complete. Normal controls will be administered the same questionnaires, except altered to not ask questions related to diagnosis or treatment of meningioma. The quality of life, symptom burden, and financial toxicity questionnaires will be administered once annually for the study duration. If possible, patient information will be retrospectively linked once annually with the California and National Death Registry to identify patients who pass away during the duration of the study.

  • FEASIBILITY (1 paragraph) – Please comment on the feasibility of using Eureka for this study and feasibility of executing the study once built.

The Eureka platform represents an ideal platform for reaching participants and administering the questionnaires, all of which are amenable to digitizing. The study team members are committed to the creation of a UCSF multidisciplinary meningioma program aiming to improve the care of meningioma patients and survivors, and are in the process of hiring a full time clinical research coordinator dedicated to meningioma related trials. Living With Meningioma will play a central role in studying the long term impacts of this disease on patients.

  • FUNDABILITY (1 paragraph) – What is your current funding for this project, or if currently unfunded, how will this support funding applications?

The project is currently funded by career development funds available to the team leader, William Chen. Depending on the success of the pilot component of this study, further funding will be sought through meningioma related philanthropic funds and brain tumor research grants.

  • PROFESSIONAL DEVELOPMENT (1 paragraph) – How will this project support the professional development of the team leader and/or team members?

William Chen is a Clinical Instructor in Radiation Oncology who is in his first year out of training, and is also a K12 fellow through the Helen Diller Family Cancer Center. This project represents an integral component of his development as a clinician scientist as he seeks to achieve independent funding, and to establish a research program studying meningioma. Living With Meningioma will be a major piece of a larger plan to establish a meningioma program at UCSF which will aim to bring the latest developments in research to the bedside through clinical trials. Other trials that are in development include a trial studying shortening of radiation courses for meningioma patients, a trial studying improvements in personalization of radiation dose for meningioma patients, and a prospective registry of genomic and blood based biomarkers for meningioma patients.

  • IMPACT (1 paragraph) – What improvements will result if your research succeeds (e.g., what are the public health implications or community benefits)?

Despite being the most common primary intracranial tumor, few studies have examined long term quality of life, symptom burden, engagement in care, barriers to care, and lasting effects of surgery and/or radiotherapy, among meningioma survivors. Living With Meningioma using the unique Eureka platform would allow us to study these questions in a large cohort of meningioma survivors in a cross sectional as well as longitudinal fashion. In addition to these question, several additional questions will be able to be studied: 1) what is the rate of guideline-adherent8 follow up with MRI imaging in long term meningioma survivors, given the propensity for late recurrence of these tumors, 2) after tumor recurrence, what is the change in disease and treatment burden on meningioma survivors, 3) if patient information can be linked to death registries, capture of the rate of all-cause mortality among long term meningioma survivors in a contemporary cohort. All of these questions will help to guide future clinical trials and quality improvement efforts in order to better understand and deliver the best care for our patients living with this common brain tumor. 

 

References:

1.        Ostrom QT, Price M, Neff C, et al. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2015-2019. Neuro Oncol. 2022;24(5):v1-v95. doi:10.1093/neuonc/noac202

2.        Wiemels J, Wrensch M, Claus EB. Epidemiology and etiology of meningioma. J Neurooncol. 2010;99(3). doi:10.1007/s11060-010-0386-3

3.        Brastianos PK, Galanis E, Butowski N, et al. Advances in multidisciplinary therapy for meningiomas. Neuro Oncol. 2019;21:I18-I31. doi:10.1093/neuonc/noy136

4.        Nassiri F, Suppiah S, Wang JZ, et al. How to live with a meningioma: Experiences, symptoms, and challenges reported by patients. Neurooncol Adv. 2020;2(1). doi:10.1093/noajnl/vdaa086

5.        Henzel M, Fokas E, Sitter H, Wittig A, Engenhart-Cabillic R. Quality of life after stereotactic radiotherapy for meningioma: A prospective non-randomized study. J Neurooncol. 2013;113(1). doi:10.1007/s11060-013-1099-1

6.        Kent EE, Arora NK, Rowland JH, et al. Health information needs and health-related quality of life in a diverse population of long-term cancer survivors. Patient Educ Couns. 2012;89(2). doi:10.1016/j.pec.2012.08.014

7.        Baba A, Saha A, McCradden MD, et al. Development and validation of a patient-centered, meningioma-specific quality-of-life questionnaire. In: Journal of Neurosurgery. Vol 135. ; 2021. doi:10.3171/2020.11.JNS201761

8.        Goldbrunner R, Minniti G, Preusser M, et al. EANO guidelines for the diagnosis and treatment of meningiomas. Lancet Oncol. 2016;17(9):e383-e391. doi:10.1016/S1470-2045(16)30321-7