Background

Integrative health equity (IHE) is defined as optimal health for all through a whole person approach that explicitly recognizes cultural, social, and structural determinants of health across the life course. Integrative health equity is a unique, innovative approach to addressing unmet health needs. The UCSF Osher Center for Integrative Health (OCIH) has partnered with numerous community organizations on IHE projects, with support from MZHF. Through community-academic partnerships, we developed and tested strategies for integrative health equity by (1) creating interventions that are socio-culturally tailored for historically marginalized populations and (2) increasing access to integrative healthcare (e.g., acupuncture, mindfulness) in safety-net and community-based settings. These projects have demonstrated positive impacts of integrative healthcare for the management of pain, stress, and chronic conditions in marginalized populations. We see these experiences reflected in the work of colleagues around the country who are working towards IHE through clinical practice and innovative research. 

Community engagement is recognized as a critical element for improving health outcomes in historically marginalized populations and reducing healthcare inequalities (O’Mara-Eves et al., 2015). Our prior community partnerships combined IHE and community engagement strategies to address significant public health needs among vulnerable populations in San Francisco (e.g., diabetes self-management in Cantonese-speaking elders; psychosocial needs of low-income individuals with complex chronic conditions; and undertreated chronic pain in diverse safety-net primary care patients). After nearly three years of the COVID-19 pandemic, the needs of these communities have in many cases been intensified by socio-structural factors including racism, social isolation, and delayed medical care. Despite the success of these projects, sustaining integrative healthcare programs beyond grant funding periods has been challenging, limiting the longer-term impacts of our partnerships. Supporting ongoing partnerships by sustaining and expanding them is critical for advancing health equity beyond incremental progress. Centering MZHF values of Innovation (Hidush), Service (Avodah), and Community Building (Kehilah), we will develop a scalable and sustainable infrastructure that fundamentally shifts the way we partner. by moving away from transactional research-driven projects to a relational, mutual process centering community needs.  

List of Goals 

The overarching goal of our current proposal is to build structures and processes to support sustainable community-academic partnerships for integrative health equity. Throughout the project we aim to foster high levels of community engagement by centering the voices of individuals with lived experience, planning in ways that are community driven, and prioritizing the relationships between collaborators. The proposed project will develop long-term work towards integrative health equity at OCIH on the Mt Zion campus in collaborative partnership with community-based organizations to make integrative healthcare a core element of accessible, culturally responsive care. Our proposal draws on principles of community-based participatory research as well as recommendations from the UCSF study of Accelerating Systematic Stakeholder Patient and Institution Research Engagement (ASPIRE). This proposal is part of a broader Osher Center Integrative Health Equity Initiative, aimed at creating sustainable structural change and being a national model. We aim to support existing community-academic partnerships while creating infrastructure that will demonstrate long-term commitment to this approach.

Specific Aims

Towards this goal, the current proposal aims to: 

(1) Build capacity for three community-academic partnerships to advance integrative health equity in San Francisco. We will do this by embedding integrative health services into existing programming at On Lok and the Shanti Project, providing integrative medicine training to biomedical clinicians (e.g., family medicine residents) through San Francisco Health Network, and providing community-engaged learning to integrative health trainees. 

(2) Create mechanisms for ongoing feedback from and accountability to community partners of the Osher Center. We will establish an Osher Center Community Advisory Board (CAB) that includes staff member and patient representatives from four partner organizations. This CAB will meet quarterly with Osher Center leadership to advise on IHE priorities and projects. CAB activities will also include opportunities for co-learning across the projects described in Aim 1 as well as experiential learning about integrative health. 

(3) Identify and disseminate promising practices for community-academic partnerships focused on integrative health equity. We will conduct a needs assessment of integrative health equity partnerships in San Francisco, followed by an in-depth evaluation of the three partnerships described in Aim 1. We will then disseminate learnings to local and national networks of community-based and academic organizations involved with integrative health equity work. 

Approach/Activities for Aim 1: Build capacity for three community partnerships to advance IHE in SF.

We will continue developing three community-academic partnerships that support the physical and mental health of adults with chronic conditions in San Francisco who are low-income, people of color, LGBTQ+, and/or have limited English proficiency (see attached document “Community Partnership Details” which provides descriptions of each project team, community partner, project goals, and timeline). We selected partnerships that have several commonalities: 

• Share a common motivation to increase access to integrative healthcare and advance health equity
• Serve marginalized communities focusing on adults living with chronic conditions that have been exacerbated by the COVID pandemic and resulting social isolation 
• Offer group-based interventions with high potential for sustaining integrative health services in low-resource settings
• Have received past funding from MZHF and would benefit from capacity-building support to sustain their programs

These partnerships are delivered in distinct settings, address multiple components of integrative health equity, involve multiple OCIH employees, and provide community-engaged learning opportunities for trainees in OCIH fellowship programs. We intentionally chose projects with a history of community partnership at different phases of program development. Collaborating with three separate partners serving distinct populations will allow for testingmultiple strategies for capacity-building, meeting the needs of each organization. This will also allow us to refine and institutionalize key factors common across partnerships to better support integrative health equity (IHE). 

IHE strategies employed by the projects in Aim 1 include providing whole person, culturally responsive care to low-income people living with chronic conditions. Each site has IHE champions who have been involved in the development of this proposal. The focus on capacity-building in three organizations (e.g., train the trainer models) will support IHE sustainability beyond the period of the proposed grant, and facilitate longer-term expansion of access to integrative care. 

1a. Integrative Approaches to Healthy Aging with On Lok.  Asian American elders experienced heightened stress, fear, and anxiety amidst increased anti-Asian hate and violence over the past two years. This project will expand the Integrative Nutritional Counseling (INC) program—which combines Chinese medicinal foods principles with biomedical nutrition advice—to include movement/exercise groups such as tai chi and qi gong adaptable for a range of physical abilities and to provide mental health support.  We will partner with On Lok Program of All-Inclusive Care for the Elderly, whose clientele is 72% Asian and 55% Chinese speaking and experiences a high burden of chronic conditions addressed by INC. We will build sustainability by training On Lok staff to deliver the INC nutrition and movement program as part of existing services. This will address gaps identified by our partners at On Lok, who shared the need for culturally responsive movement programs for elderly people with a range of abilities: “One site is not currently offering any tai chi and another only shows YouTube videos. One concern in offering tai chi classes to seniors is that many of them use walkers and canes when standing, thus practicing standing tai chi may not be easy.” 

1b. Sharing Humanity through Arts, Reflection, and Expression (SHARE) with the Shanti Project. Cultivating social connectedness is critical for addressing isolation and loneliness exacerbated by the COVID-19 pandemic. SHARE provides integrative support to multiple Shanti programs, of whose clientele, 60% receive disability for a diagnosis of primary mental illness, and 37% for an unexplained mind-body syndrome. Monthly in-person group meetings will offer experiential integrative health opportunities such as mind-body skills practice, Ayurveda, East Asian Medicine, and biofeedback. SHARE broadens approaches to integrative health communication by including immersive experiences, the arts, and mind-body awareness. Groups will address topics that impact a large number of Shanti clients—HIV, cancer, and aging—as well as personalize the experience for the participants based on their needs. This aligns with feedback we received from Shanti clients, who spoke to how “People want to know who is going to be there, who is going to be leading it, will they be safe” and want “to access acupuncture, massage, biofeedback in a familiar environment.”

1c. Expanding Integrative Pain Management, with the Tom Waddell Urban Health Clinic and San Francisco Health Network (SFHN). Over 20% of adults suffer from chronic pain and rates are higher among low-income individuals. With the ongoing opioid crisis, providing non-medication approaches for pain is an urgent priority. The Integrative Pain Management Program (IPMP) was established to broaden access to group-based integrative care for racially and ethnically diverse patients in a primary care safety net clinic in the Tenderloin, with the vision to expand access to integrative care for all SFHN patients with chronic pain. This project will provide training on integrative health and group facilitation to SFHN clinicians and clinicians in existing UCSF/SFHN training programs (e.g., addiction medicine fellowship, primary care residencies). We will build capacity by training clinicians to expand integrative pain care to racially and linguistically diverse safety-net patients throughout the city. This responds to patient feedback about the need for integrative pain management in primary care: “IPMP reinforced stuff that I knew I should be doing. But of course, I can’t do acupuncture on myself. I can’t do massage on myself. I’m poor – like really poor – and I can’t afford to go and get that stuff done at some slinky spa somewhere. So, it’s great to have access to it in my primary care clinic.”  

Approach/Activities for Aim 2: Create mechanisms for ongoing feedback from and accountability to community partners of the Osher Center.

We will establish a Community Advisory Board (CAB) to provide a forum for co-learning across integrative health equity partnerships (including those described in Aim 1) and to advise on OCIH’s clinical, research, education, and community programs. This group will meet with OCIH leadership every three months, and participants will receive honorariums for their time and expertise. CAB participants will include a staff member and a client/patient from four community-based organizations (3 established and 1 new partnership), and two OCIH patients who received support through our Community Care Fund. We will regularly elicit feedback and assess the impact of the CAB. This will allow us to promptly respond to feedback with the goal of strengthening engagement of CAB members and developing tools that can be used by other Mount Zion based community partnerships.  

The Osher Center CAB will be aligned with broader UCSF efforts to increase community engagement, such as the Center for Community Engagement and best practices identified by the UCSF ASPIRE study. The CAB will: 

• Foster ongoing relationships focused on developing and sustaining integrative health equity.
• Enhance collective learning to strengthen community-academic partnerships. 
• Provide experiential opportunities for CAB members to familiarize themselves with a range of integrative health practices, strengthening their experience in advising on Osher Center research and education programs. 
• Inform OCIH priorities and practices. 
• Include a mechanism for recruiting appropriate advisors for ongoing individual projects (e.g., a project focused on integrative pediatric care that would benefit from community advisors who are parents or work with children). 

In Year 1, we will identify CAB members and establish group processes, including a practical and experiential orientation to the Osher Center’s work. In years 1-3, the CAB will have quarterly meetings with the OCIH leadership team including the Center Director, Clinic Director, Director of Research, Director of Education, and Associate Director for Health Equity and Diversity. The Integrative Health Equity Program Manager will coordinate the CAB meetings and support CAB members in providing feedback on community-based projects, such as the ones described in Aim 1. OCIH leadership will benefit from consistent guidance from the CAB on how to ensure that Osher programming serves the needs of a diverse range of San Francisco residents. 

Approach/Activities for Aim 3: Identify and disseminate promising practices for community-academic partnerships focused on integrative health equity.

In order to provide data and models that can be employed in San Francisco and beyond, Aim 3 focuses on evaluation and dissemination across projects. In Year 1, we will conduct a citywide scan of integrative health equity partnerships, including but not limited to the community-academic partnerships in Aim 1. Interviews with community-based organization staff and clients as well as their academic collaborators will elicit successes, challenges, and recommendations for strengthening partnerships at an organizational level and towards community impact. We will include ongoing and partnerships between community-based organizations and researchers (e.g., Homeless Prenatal Program, Larkin Street Youth Services, Year Up Bay Area, Sisterweb, Rafiki Coalition, the ARCH/TCM working group, and Mujeres Unidas y Activas). This broad scan will allow us to begin identifying best practices in IHE partnerships.

In Year 2, we will evaluate the three partnerships that are part of Aim 1 using mixed methods instruments developed for community partnerships (Reese et al., 2019). We will use frameworks developed for realist evaluations which focus on answering questions such as what works, for whom, in which circumstances, and why. Using interviews and program implementation data, we will examine factors contributing to sustainability at institutional and programmatic levels (e.g., organizational capacity, program characteristics, funding, staff champions) (Bodkin & Hakimi, 2020). Building on past literature, we will assess how these partnerships have facilitated capacity-building for each of the three partners to offer integrative health services. 

In Year 3, we will focus on dissemination of what we have learned about community-academic partnerships for integrative health equity. We will share preliminary findings with the Community Advisory Board (see Aim 2), then integrate their feedback to create accessible materials summarizing these findings. These materials will be disseminated to community and academic partners locally and nationally through networks conducting integrative health equity work, including the 11 academic centers of the Osher Collaborative for Integrative Health, as well as Integrative Medicine for the Underserved, a national organization. Finally, we will host a daylong event for community-based organizations and researchers focused on IHE partnerships. 

Summary of healthcare-related needs being addressed: Integrative medicine can reduce health disparities and advance health equity through whole person, culturally responsive care for complex conditions that disproportionately impact historically marginalized populations. However, integrative health is not equally accessible for all due to high out-of-pocket expenses and other barriers. The partnerships described in Aim 1 support adults from marginalized communities with a disproportionate burden of chronic conditions, including diabetes, chronic pain, HIV, cancer, and mental health challenges. Aims 2 and 3 will address a broader range of healthcare-related needs across the lifespan, including specific needs emerging from the COVID-19 pandemic (e.g., impacts on mental health, social isolation). The project is designed to strengthen partnerships that respond to current and emerging healthcare needs of vulnerable populations in San Francisco.

MZHF/Jewish values: Based at the Mount Zion Campus, the UCSF Osher Center for Integrative Health will serve as the hub for all proposed project activities. This includes the core academic team (Drs. Chao, Thompson-Lastad, Adler and Chan), the program manager, and OCIH staff involved with the community partnerships. Administrative, fiscal, and programmatic oversight will all be located at the Mount Zion Campus. The community organizations serve populations within the Mount Zion catchment area, focusing on historically marginalized communities. The proposed integrative health equity program embodies MZHF’s core Jewish values: 

• Avodah (service): Community-based organizations in these partnerships serve adults with chronic conditions in multiple ways, including increased access to integrative health services. These efforts are recovering from the COVID-19 pandemic, which increased physical and mental health needs in marginalized communities. The IHE program plans to address this by providing financial and technical support to community-based organizations. 
• Tikkun Olam (social justice): The focus of the IHE program is to address socioeconomic and racial inequities in access to integrative medicine and institutional resources more broadly.
• Kehilah (community building): One of the successes of community partnerships is building relationships among community organizations and university representatives. The COVID-19 pandemic has in some cases worsened silos between organizations and sectors, while creating new partnership opportunities in other cases. Our hope is that the IHE initiative will foster connection and build community among organizations and the people that are part of them. 
• Limud u’Manhigut (education and leadership): This project will support and involve leadership of community organizations and develop collaboration between the UCSF Osher Center and a range of community organizations. It will also contribute to education programs by providing opportunities for community-engaged learning and applied research projects for trainees at UCSF and other institutions.
• Hidush (innovation): The proposal takes an innovative approach to community-academic partnership and increasing access to integrative healthcare, with a focus on capacity-building that will last beyond the period of this grant. 

Information about Partners

Community Project Partners include representation from multiple San Francisco-based organizations:

• Sunny Pak, Associate Medical Director, On Lok, 
• Evelyn Y. Ho, Professor, University of San Francisco
• Tammy Kremer, Public Health Communications Specialist, California Prevention Training Center 
• Liz Stumm, Director of Community Partnerships and Program Evaluation, Shanti Project; 
• Jesse Wennik, Nurse Practitioner, San Francisco Health Network
• Pamela Swedlow, Physician, San Francisco Health Network
• Folashade Wolfe-Modupe, Physician, San Francisco Health Network

Partners from UCSF Osher Center for Integrative Health (OCIH) include

• Maria T. Chao, Associate Director for Health Equity and Diversity
• Ariana Thompson-Lastad, Assistant Professor 
• Shelley Adler, Director
• Selena Chan, Interim Director of Clinical Programs 

Roles of Partners: Partners will jointly foster community engagement by centering the voices of individuals with lived experiences, planning in ways that are community-driven, and prioritizing relationships between collaborators. Community partners will provide an established presence in their respective communities, relevant lived experiences, and informed perspectives on community priorities and feasibility. OCIH partners will provide administrative coordination, technical support for evaluation, and expertise in integrative health. 

Project leadership and background: All partners named above have extensive skill sets and experience with community partnerships, integrative health, and healthcare in marginalized communities. The principal investigators, Drs. Chao and Thompson-Lastad, have led multiple community-academic collaborations on integrative health equity, have 10 years of experience working together, and will ensure that project activities are accomplished. 

Project start date: April 1, 2023, three-year duration.

Estimated total budget: $250k/year; the amount requested from MZHF is $150k/year.

1. Applicant/s name; title; UCSF Mount Zion academic affiliation; Community Partner affiliation (if applicable)

Applicant: Dr. Shannon Fogh, Associate Professor of Radiation Oncology 

Community Partner: Maple Tree Cancer Alliance

 Project Title: Implementation of a Structured Exercise Program for Oncology Patients

List of Goals:

1. Demonstrate the feasibility of patient participation and adherence to a prescribed exercise program. Specifically, the percent of patients exercising >150 minutes per week at baseline, 6 and 12 weeks and frequency and type of adverse events.
2. Understand and validate the best exercise strategies for patients with cancer and modifications appropriate for different places in the patients’ disease and treatment.
3. Measure and evaluate the functional outcomes of participation, including Timed-up and Go (TUG) test, 30 Second Chair Stand, Four Stage Balance Test and BMI.
4. Evaluate patient-reported health-related quality of life as measured by the global QOL, physical functioning, role functioning, and social functioning domains on the EORTC Quality of Life Questionnaire (QLQ-C30). 
5. Understand unique patient preferences and barriers to participation for patients with varying functional status and across different demographics.
6. Assess relationships between functional outcomes and quality of life. 
7. Assess health care utilization, including ER visits and hospitalizations of participants.

 Summary of healthcare-related needs being addressed:

Cancer is a significant national health problem. The long-term physical and psychological side effects of cancer and its treatment negatively impact the cancer survivor’s quality of life, causing cancer to be classified as a chronic disease by the Centers of Disease Control. Survival, while the most common outcome measure, may not address components of a patient’s quality of life. How toxicities of treatment are managed makes a great difference in quality of life both during and after treatment. 

 Exercise has been demonstrated to positively impact patients with cancer, and government and leading health organizations such as the American Institute for Cancer Research, American Cancer Society (Clark et al), and the American Society of Clinical Oncology (Ligibel et al 2022) have included exercise among cancer-prevention guidelines. The 2019 Exercise Guidelines for Cancer Survivors was based on a consensus statement from an International Multidisciplinary Roundtable recommending a combination of aerobic and resistance exercise based on multiple studies demonstrating benefit in cancer patients across multiple symptom domains from fatigue and functional status to mood and quality of life. Importantly, many studies have also demonstrated an overall survival benefit when exercise guidelines are met. Conversely, studies have demonstrated a fivefold increase in death in patients who are not active.

Despite these recommendations, most hospitals and clinics have not implemented personalized cancer exercise programs due to workforce, funding, and infrastructure limitations. This represents a quality gap between what we know benefits patients with cancer and the implemenation of an intervention which has continuously demonstated a positive impact on patients. Specifically, when provided as part of a comprehensive cancer plan, individualized exercise has clear benefits, including reductions in treatment-related side effects, higher chemotherapy completion rates, improved physical fitness and functionality, and increases in health-related quality of life. Further, reductions in health care utilization have been reported. This is noteworthy as unplanned hospitalizations contribute half of the cost of cancer care. Nevertheless, 85% of patients are sedentary at the time of their diagnosis, and shockingly, less than 5% engage in exercise programs during cancer treatment. Furthermore, less then 5% of cancer patients are ever referred to an exercise program, and approximately 2% of patients meet the published exercise recommendations.

Challenges inherent to creating a generalizable program for all patients include the wide range of physical deficits patients can present with, depending on the location of the cancer and prior and current treatments and medications. This can lead to considerable variability in baseline strength, balance, and muscle mass. Steroid use, as well, can deplete muscle mass and create difficulty with completing traditional exercises. This is exacerbated by fluctuating side effects, including radiation-induced fatigue, arguing for an individualized and flexible program providing patients with options when side effects of treatment are more prevalent. 

The UCSF Cancer Exercise Counseling Program has led an important effort within the Cancer Center to offer one-on-one fitness counseling to adult cancer patients and survivors. During a one-hour session with an exercise counselor, patients receive education and training on activities related to cardio, strength, balance, and flexibility. These efforts are entirely supported by gift funds, and there is no cost to patients. While this program has been an incredible asset to patient care, important limitations include:

1)    Exclusion of patients who do not speak English as a primary language.

2)    Availability: Currently only one exercise specialist is available with 8 clinic slots per week.

3)    Exclusion of many of our patients based on physical abilities: This service is limited to fully functional patients who are able to safely perform these activities at a baseline level. 

4)    A focus on exercise counseling vs. implementation of a true exercise intervention.

These limitations exclude many of our patients who have graduated from physical therapy and could benefit from a structured exercise program. Specific examples include patients who do not speak English as a primary language, as well as patients who have deficits from their primary tumor or treatment. This includes patients who are non-ambulatory or who have pain or neurologic symptoms, including cognitive changes, motor function, balance, visual symptoms, and other physical deficits which can be amplified by traditional treatments including surgery, systemic therapy, and radiation therapy. 

While there are challenges inherent to creating a generalizable program for all patients, the Maple Tree Cancer Alliance has created exercise programing for patients with both physical limitations and has made substantial efforts to offer exercise programs to patients who do not speak English. Maple Tree has developed trainers with experience in working with patients with functional deficits, including patients who are not ambulatory or have pain or other physical limitations. Additionally, they have developed materials that are available in Spanish, Mandarin, Portuguese, and Arabic. They are actively hiring trainers proficient in multiple languages and are comfortable offering sessions with the assistance of an interpreter, as well.

The purpose of this proposal is to demonstrate the feasibility of implementing individualized exercise programs for patients with cancer and their impact on functional measures and patient reported quality of life and cognition. We will also assess patient exercise preferences, barriers to activity and modifications appropriate for different functional limitations. Our long-term goal is to develop programs for every patient in the cancer center, regardless of their functional limitations, primary language, or socioeconomic status, and to engage them as early as possible and support them through their treatment journey. 

Roles of UCSF and Community Partner(s), if applicable

The exercise program will be offered through a partnership with Maple Tree Cancer Alliance, a 501(c)(3) non-profit organization that has developed a unique, evidence-based model of exercise programming that has gained national attention. 

Name(s), title(s), agency/department/division(s) of individuals who will lead the project, with brief background information relevant to ability to accomplish the project activities

Dr. Shannon Elizabeth Fogh is a Radiation Oncologist and Integrative Oncologist. After completing her  fellowship in Integrative Medicine, Dr. Fogh joined the faculty at the Osher Center for Integrative Health with a practice focused on integrative approaches for all patients living with a cancer diagnosis. Her research interests are centered on developing and implementing integrative treatments to improve survival, reduce treatment toxicities  and improve quality of life and preservation of neurocognitive function. She was integral to the efforts to implement and study the impact of a dedicated exercise program for patients with primary brain tumors and is dedicated to implementing individualized exercise programs for patients living with and beyond cancer. 

Karen Wonders, Ph.D., FACSM, is the Founder of Maple Tree Cancer Alliance. She also serves as a Professor of Exercise Physiology at Wright State University and Program Director over the undergraduate Exercise Science Program. The primary focus of her research is on the physiological and financial impact of exercise during cancer treatment. 

Other Investigators/Collaborators:

Kavita Mishra; Integrative Oncologist, Osher Center Faculty

Donald Abrams: Integrative Oncologist, Osher Center Faculty

Natalie Marshal: Integrative fellowship graduate with expertise in implementation of exercise programs for cancer patients.

Note which of the six MZHF values the project embodies: 

• Service (Avodah): A major goal of this project is serving all patients with a cancer diagnosis who can and should be able to benefit from the impact exercise can have on survival, functional status, and quality of life.
• Social Justice (Tikkun Olam): This project seeks to create inclusive exercise programing by including patients with physical limitations and patients who do not speak English as a primary language.
• Innovation (Hidush): We seek to be one of the first cancer centers in the United States to implement exercise programming and to measure the qualitative and quantitative impact of formal exercise programing. 
• Compassion (Rahamin): By creating programs that do not exclude participation based on physical ability, socioeconomic status, or language barriers.

 Project start date and duration (earliest start date is January 1, 2023):

 March 1, 2023-March 2024

Estimate of total budget required and the amount requested from MZHF.

 $75,000

Proposal: 

1: Specific Aims: 

The aims of the proposed project are to understand the feasibility of and barriers to implementing a comprehensive exercise program for patients with cancer, as well as the program’s impact on functional outcomes and health related quality of life.  We will also assess patient exercise preferences, barriers to activity and modifications appropriate for different functional limitations. Our long-term goal is to develop programs for every patient in the cancer center and engage patients as early as possible and support them through their treatment journey. 

 The hypothesis will be tested by addressing the following aims:

1. Demonstrate the feasibility of patient participation and adherence to a prescribed exercise program. Specifically, the percent of patients exercising >150 minutes per week at baseline, 6 and 12 weeks and frequency and type of adverse events.
2. Understand and validate the best exercise strategies for patients with cancer and modifications appropriate for different places in the patient’s disease and treatment.
3. Measure and evaluate the functional outcomes of participation including Timed-up and Go (TUG) test,  30 Second Chair Stand, Four Stage Balance Test and BMI.
4. Evaluate patient-reported health-related quality of life (HRQOL), as measured by the global QOL, physical functioning, role functioning, emotion functioning and social functioning domains on the EORTC Quality of Life Questionnaire (QLQ-C30). In addition, to measure patient-reported cognitive function, as measured by the cognitive functioning subscale of the EORTC QLQ-C30.
5. Understand unique patient preferences and barriers to participation in patients with varying functional status and across different cultures and socioeconomic status.
6. Assess relationships between functional outcomes and quality of life. 
7. Assess health care utilization including ER visits and hospitalizations of participants.

 Experimental Design and Methodology: 

This is an observational, mixed methods implementation science pilot study examining the feasibility, adherence, and impact of a tailored exercise program for patients with cancer.

Patients will be referred to a certified exercise specialist by e-mail or through the electronic medical record (EMR). Following this referral, a patient intake appointment is completed to assess baseline functional and quality of life status, health concerns, health history, current fitness/activity levels, available resources, and desired goals. Patients will be assessed for function and quality of life at 3 time points throughout the duration of the trial. These include at initial assessment and at 6 weeks and 12 weeks, after starting the program. Completion of quality-of-life forms will be done electronically or by patient interview. Quality of life forms are offered in multiple languages and support will be provided to patients who may not have access to computers or other means to complete the survey and/or patients who might struggle with navigating an online survey.

 As this program is intended to complement and supplement existing exercise resources, we will work closely with relevant stakeholders to maximize availability of services to patients. Priority will be given to vulnerable patient populations including but not limited to, patients with physical limitations or impairments, patients with limited access to exercise resources and patients who do not speak English.

 Based on the results of the initial assessment, an exercise prescription is developed. This exercise intervention is individualized according to the patient’s current health status and goals and is in-line with ACSM’s published guidelines on exercise for cancer patients. Exercises will include cardiorespiratory endurance, muscular strength, and balance. Exercise duration and intensity are systematically progressed based on patient tolerance. All sessions are completed one-on-one with a trainer who holds a minimum of a bachelor’s degree in an Exercise Science-related field and a nationally accredited Exercise Oncology Instructor certification. The individualized program will be sent to the patient through the EMR with links to the appropriate resources for further assistance. 

The individualized exercise program will last 6-12 weeks depending on the individual plan created for the patient.

 After completion of the program, participants will repeat the assessments done at baseline pertaining to functional status, cognitive function, and quality of life. Patient adherence will also be measured. These assessments will be repeated at 12 weeks following the start of the program to assess for sustainability of program recommendations for exercise and functional and quality of life outcomes.

 Primary Objectives/outcomes: 

• Patient demographics including age, diagnosis, sex, previous and current treatment, and medications including dose and duration of steroids and antiepileptic medications.
  
  
• Number of patients referred and individual and overall adherence with the program, including number of prescribed sessions completed percent of patients exercising >150 minutes per week at baseline, 6 and 12 weeks (as able).

• Patients’ ability to complete prescribed exercise as well as any feedback about challenges or difficulties they faced in completing certain exercises. We will track modifications based on this feedback. This will allow us to understand and validate the best exercise strategies for individual patients and modifications appropriate for different places in the patient’s disease and treatment. This qualitative data will be collected by interviews, open text boxes for feedback as part of electronic surveys and ongoing dialogue with the exercise counselor during visits.
  
  
• Cardiovascular fitness/functional status will be measured by: 

                       Timed-up and Go (TUG)
                       30 Second Chair Stand
                       Four Stage Balance Test

• Body Mass Index (BMI) based on height and weight recorded at a clinic visit within 3 months or self-reported

• Current weekly steps as self-reported by a mobile fitness app (if available)

• Patient-reported health-related quality of life (HRQOL), as measured by the global QOL, physical functioning, role functioning, emotion functioning and social functioning domains on the EORTC Quality of Life Questionnaire (QLQ-C30). 

• Patient-reported cognitive function, as measured by the cognitive functioning subscale of the EORTC QLQ-C30.

• Adverse events: Determined by frequency, type or absence of significant adverse events recorded during the study period to include experiencing chest pain, shortness of breath, falls, and dizziness (without falls) during exercising. Minor adverse events could include muscle pain and use of OTC pain medication after exercising. 

• Health care utilization including ER visits and hospitalizations of participants.

Primary Objective: 

The primary objective of this investigation is to assess the feasibility, recruitment, adherence, and impact of a patient’s participation in a supervised, individualized exercise program for oncology patients. The intervention will be considered feasible and with a high adherence if  this study produces less than 20% exercise dropout rate and 70% completion of prescribed exercises over the 6-week program.

Secondary Objectives: 

Changes in functional outcomes from baseline to post-intervention at 6 weeks and 3 months including

• Timed-up and Go (TUG) 
• 30 Second Chair Stand 
• Four Stage Balance Test
• Body Mass Index (BMI) based on height and weight recorded at a clinic visit within 3 months or self-reported
• Current weekly steps 

Changes in patient-reported health-related quality of life (HRQOL), as measured by the global QOL, physical functioning, role functioning, emotion functioning and social functioning domains on the EORTC Quality of Life Questionnaire (QLQ-C30) post-intervention (6 weeks) and 3 months. 

Changes in patient-reported cognitive function, as measured by the cognitive functioning subscale of the EORTC QLQ-C30 at initial assessment and at three months from baseline. 

 Quality of Life and Functional Outcomes assessment tools

The EORTC QLQ-C30 is the instrument most frequently used to measure quality of life (QOL) in cancer patients. Importantly, it is offered and is validated in over 50 languages.

The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults. It measures both static and dynamic balance and is used to help determine current performance level and how safe it is to complete certain activities. It will be used in this patient population to help determine the appropriate exercise program and to monitor progress throughout the program.  [https://www.cdc.gov/steadi/pdf/TUG_test-print.pdf]

The Four-Stage Balance Test is used in conjunction with other measures such as the 30 second Chair Stand Test and TUG test as an assessment of postural hypotension which can help indicate if a patient is a risk of falling. In this test, patients are asked to perform four progressively more challenging positions without the help of an assistive device. Specific positions each held for 10 seconds with patients eyes open include a parallel stance, semi-tandem stance, tandem (Heel-Toe) stance and one-legged stance. [https://www.cdc.gov/steadi/pdf/4-Stage_Balance_Test-print.pdf] 

The 30 Second Chair Stand, combined with other tests can help evaluate risk of postural hypotension and a patient’s risk of falling in addition to leg strength and endurance. The number of times patients can rise to a full standing position and return to a seated position during a 30 second interval is documented. This can be helpful in creating an appropriate exercise program as well as monitoring progress as patients increase activity.  [https://www.cdc.gov/steadi/pdf/STEADI-Assessment-30Sec-508.pdf]
 

Data collection: 

Data will be collected by electronic survey and patient interviews and stored in a REDCAP database.

Plan for evaluation and data analysis: 

Primary endpoint: 

The primary endpoint is feasibility, defined by adherence of patient’s participation in a customized exercise program for patients with cancer. The intervention will be considered feasible with a less than 20% drop out rate and 70% completion of exercises in patients enrolled. We anticipate enrolling 50 patients in one year.

Secondary endpoints: 

Changes in patient functional outcomes from baseline, post-intervention and 3 months assessed for each individually:

• Timed-up and Go (TUG) 
• 30 Second Chair Stand 
• Four Stage Balance Test
• Body Mass Index (BMI) based on height and weight recorded at a clinic visit within 3 months or self-reported
• Current weekly steps as self-reported by a mobile fitness app (if available)

Improvement in patient-reported health-related quality of life (HRQOL), as measured by the global QOL, physical functioning, role functioning, emotion functioning and social functioning domains on the EORTC Quality of Life Questionnaire (QLQ-C30) at baseline, post-intervention and at 3 months. Since higher scores indicate better functioning, an increase of 10% from baseline indicates an improvement in function.  

Improvement from baseline to post-intervention and 3 months following the intervention in the following subscales will be assessed and compared using Fisher’s exact test: global QOL, physical functioning, role functioning, emotional functioning, and social functioning domains along with fatigue and pain items. 

Exploratory Outcomes: 

Assess barriers for participants to participating in an exercise program by a survey conducted within the first 2 weeks of study participation. Results of a survey will be presented using descriptive statistics. 

Aim five focuses on understanding the barriers and facilitators to uptake and successful completion of the exercise program by a demographically diverse group of participants. Pilot data we have collected indicates that exercise preferences and barriers differ across patients from different cultures, functional and socioeconomic status. To ensure diversity of responses we will perform one-on one interviews with 15 Mandarin, Spanish and English-speaking patients selected for varying levels of completion of the pilot program. Additionally, we will interview 15 patients with high functional status (defined as KPS of 90 or above) and compare to patients with low functional status < KPS of 80) or with an identified physical deficit. All patient interviews and surveys will be additionally stratified by socioeconomic factors including but not limited to income and education level.

Interviews will focus on asking patients if they were able to exercise as much as they had planned, what barriers they faced to exercising,  their satisfaction with the program, what factors associated with the program helped them exercise more, how the program helped them cope with cancer and how their quality of life was affected by the program.

Additionally, we hope to assess relationships between functional outcomes and quality of life.  

Finally, we hope to analyze hospitalizations and urgent care visits of participating patients to develop pilot data for understanding the impact of exercise on health care utilization.

2. Anticipated benefit for underserved or vulnerable communities in San Francisco: 

One in three people will develop cancer in their lifetime and between 54.4-90% will have some physical or functional limitations depending on the location of the cancer and prior and current treatments and medications. This can lead to considerable variability in baseline strength, balance, and muscle mass. Steroid use can deplete muscle mass and create difficulty with completing traditional exercises. This is exacerbated by fluctuating side effects including radiation-induced fatigue. This can lead to challenges leaving the home, social isolation, navigating physical barriers at home such as stairs and even completing activities of daily living, creating vulnerabilities in this patient population. Importantly, approximately 40% of patients diagnosed with cancer do not speak English and 20% are at or below the poverty level without financial means to pay for in-house therapy, personal trainers, access to gyms or exercise equipment. 

The UCSF Cancer Exercise Counseling Program has led an important effort within the cancer center to offer one-on-one fitness counseling to adult cancer patients and survivors. During a one-hour session with an exercise counselor, patients receive education and training on activities related to cardio, strength, balance, and flexibility. These efforts are entirely supported by gift funds. While this program has been an incredible asset to patient care, important limitations include:

• Exclusion of patients who do not speak English as a primary language.
• Availability: Currently only one exercise specialist is available with 8 clinic slots per week.
• Exclusion of many of our patients based on physical abilities: This service is limited to fully functional patients who are able to safely perform these activities at a baseline level. 
• A focus on exercise counseling vs a true exercise intervention.

These limitations exclude many of our patients who have graduated from physical therapy and could benefit from a structured exercise program. Specific examples include patients who have deficits from their primary tumor or treatment, such as patients who are non-ambulatory, have pain or neurologic symptoms including cognitive changes, motor function, balance, visual symptoms, and other physical deficits which can be amplified by traditional treatments including surgery, systemic therapy, and radiation therapy. Importantly, this also excludes patients who do not speak English as a primary language.

Role of Community Partner:

While there are challenges inherent to creating a generalizable program for all patients, the Maple Tree Cancer Alliance has created exercise programing for patients with both physical limitations and has made substantial efforts to offer exercise programs to patients who do not speak English. They have developed trainers with experience in working with patients with functional deficits, including patients who are not ambulatory or have pain or other physical limitations. Additionally, they have developed materials that are available in Spanish, Mandarin, Portuguese, and Arabic. They are actively hiring trainers proficient in multiple languages and are comfortable offering sessions with the assistance of an interpreter as well.

3: How the project addresses UCSF Mount Zion priorities and compelling San Francisco healthcare needs.

This project would provide a critical service free of charge to underserved and vulnerable patients diagnosed with cancer. There is a significant gap between national guidelines that recommend exercise to benefit quality of life, mitigate treatment related symptoms and improve survival and, access to resources to facilitate this. This is a significant unmet health-related need impacting all our cancer patients in San Francisco, including our patients seen and treated at our Mt. Zion location and patients seen in our Integrative Oncology practice at the Osher Center for Integrative Health.

Both our patients and providers want access to these resources as well! Our preliminary needs assessment, consisting of qualitative interviews and surveys with patients and multidisciplinary team members, including physicians, indicated that 100% of providers and patients reported that exercise is Important to Very Important for patients' lifestyle. Most providers (92%) reported that exercise was Important for patients' lifestyle and 80% felt it should be integrated into the treatment of patients with cancer. Ninety-six percent felt that exercise improved quality of life, decreased fatigue (100%) and reduced treatment-related side effects (92%). While patients and providers were motivated to refer and support patients’ participation in a customized exercise program, there is very limited availability of exercise counselors. Additionally, patient feedback indicated a preference to be part of a more structured program with more frequent visits, to assess progress and modify exercises if needed. 

This project embodies many of the MZHF values, including Social Justice, as we seek to create inclusive exercise programing by including patients with physical limitations and patients who do not speak English as a primary language; Innovation, as we seek to be one of the first cancer centers in the United States to implement clinical access, research, as we measure the impact of formal exercise programing; and Compassion, by creating programs that do not exclude participation based on physical ability, ability to pay, or language barriers.

4.Type and duration of campus-community partnership, if applicable: 

Plan for sustainability: 

Pilot data from this grant will be critical to determining both need for services, guidance for widespread implementation and outcomes in cancer patients including demonstration of exercise on cost savings. Specifically, there is growing evidence that exercise oncology, when properly performed, improves functional outcomes, quality of life, survival and serves as a cost savings event by reducing unplanned visits to the emergency room and decreasing the number of hospitalizations needed to manage the complications that can occur during and after treatment. 

Despite evidence that exercise can be beneficial to patients’ quality of life and survival, in addition to providing cost saving, widespread incorporation of exercise into the treatment plan of newly diagnosed cancer patients has been severely limited by the absence of many of the conventional methods for clinical activity reimbursement.

Our overall goal is to ensure this service is available to all cancer patients. We are actively working to obtain Category III CPT codes for exercise interventions. These codes are temporary codes for new and emerging therapies that allow data collection and assessment of new services to substantiate widespread usage of new and emerging interventions to justify the establishment of a permanent Category I CPT code. 

We believe pilot data from this program would be integral to this effort and to UCSF through the Mt. Zion Health Fund, which would be leading this effort to obtain reimbursement for exercise nationally and to create a national model for exercise counseling.

Pilot data from this program will also be presented to the Cancer Center leadership and be critical for ongoing infrastructure, dissemination, and support. 

5.How the community partner's experience and expertise was integrated into proposal development: 

The exercise program will be offered through a partnership with Maple Tree Cancer Alliance, a 501(c)(3) non-profit organization that has developed a unique, evidence-based model of exercise programming that has gained national attention. Maple Tree Cancer Alliance is dedicated to improving the quality of life of individuals who battle cancer that creates program of supervised, individualized exercise training. In other types of cancers, they have demonstrated improved patient outcomes in terms of increased fitness parameters, decreased symptom severity, and decreased health care utilization. 

Program Outcomes: The following charts represent the outcomes data Maple Tree has measured on the patients who have completed their programs showing improvement in domains including quality of life, multiple fitness parameters and health care utilization (see supporting documents). 

Contact information: address, email, phone

• 505 Parnassus Ave., Room L-08, Box 0226 San Francisco, CA 94143
• Shannon.fogh@ucsf.edu
• (617) 460-0900