Diversifying Electronic Cohort Research at UCSF

A community-engaged contest to select and support a diverse "eCohort" at UCSF

Pilot Test & Feasibility of a Digital Lifestyle Cohort of Diverse Individuals with Cancer

Proposal Status: 

PLAIN LANGUAGE SUMMARY - A common question that people ask after they find out they have cancer is: “What can I do to keep the cancer from spreading or coming back?” Our study aims to find answers for the millions of people worldwide who live with cancer. We will use the Internet to collect information on individual characteristics (such as age, race, where people live, who they live with, education, etc), cancer care and other diseases, and about daily life (for example, what people eat, how much they exercise and sleep, if they use any natural products or supplements or meditate, what their religious beliefs are, etc). If we can enroll a diverse group of people and follow them for several years, we will examine if different lifestyle practices lead to better cancer outcomes or can improve how people feel. To start, we will enroll people with prostate, bladder, and colorectal cancer. We will share what we learn on our website, for participants and the general public. 

RESEARCH QUESTION -  Our goal is to study if diet, exercise, and other lifestyle factors can improve quality-of-life (QOL), prognosis, and overall health of people living with cancer. Given the heterogeneous nature of cancer, we hypothesize that customizing lifestyle recommendations and tools to patients’ cancer site, socio-demographics, culture, treatments, tumor features, habits, and preferences will maximize uptake and benefit. To support this goal, we are building a novel technology-enhanced cohort that will collect detailed data on diet, exercise, sedentary habits, complementary alternative medicine practices, spiritual beliefs, sleep quality, socio-demographics, immigration history, co-morbidities, and other factors. We will follow participants for general and cancer-specific QOL and clinical outcomes (e.g., treatment-specific progression, metastasis, death) through long-term periodic medical chart review and National Death Index and cancer registry searches. These rich data will support multiple research studies across a broad range of topics. We will start by pilot testing the feasibility and acceptability of our recruitment methods, study format (digital), survey questions, and request for long-term follow-up among 300 diverse individuals with prostate, bladder, or colorectal cancer. We anticipate making iterative improvements after this pilot phase, and that through collaboration, the cohort will be comprised of sub-cohorts of thousands of individuals with various cancer types in the future.

This study will address two major gaps in the medical literature – the lack of data on lifestyle habits after a cancer diagnosis and its impact on subsequent QOL and clinical outcomes; and the lack of diversity in cohorts that have collected comprehensive lifestyle data. In the US, African Americans (AA) have the highest death rate and shortest survival of any racial and ethnic group for most cancer types. Approximately 190,000 AAs are diagnosed with cancer annually. There are extremely limited data on the impact of lifestyle factors on psychosocial and clinical outcomes in AAs with cancer. Thus, focused study on post-diagnostic lifestyle factors, and its influences on cancer outcomes, in particular among AA’s, is warranted.

This cohort was approved in 2016 to be built by the UCSF Health ePeople team on the Eureka Research Platform (Eureka) (NIH-funded 5U2CEB021881-02). A digital cohort has several potential advantages, such as reduced infrastructure costs and labor. However, a limitation may be the generalizability, due to the “digital divide”- i.e., inequity with regards to access to or use of the Internet and information and communication technology, based on age, education, income, or race. Thus, it is important to pilot test the feasibility and acceptability of this digital cohort in diverse groups, and collect data on barriers and facilitators to participation, for iterative improvements. Thus, we propose to address the following questions:

1. What is the feasibility and acceptability of a digital lifestyle cohort in adults with prostate, bladder, or colorectal cancer using online (e.g., email blasts, website ads, etc) or print-based (e.g., mass mailings using cancer registry or APEX queries, brochures in clinics, etc) recruitment methods? We will analyze response, enrollment, and survey completion rates overall and by socio-demographic factors. We will query participants on ways to improve the online study, assess the ability to obtain electronic vs. paper medical records, and assess feasibility of consent for long-term follow-up.

2. What are the best ways to engage and enroll older adults and under-represented groups into a digital cohort? We will develop and test methods for outreach to and enrollment of older adults and diverse populations, including AA’s. Based on experience, we anticipate the potential need for in-person assistance to engage and educate some groups about clinical research and the study, prior to enrollment, and for technology support. With this proposal, we welcome the opportunity to work with experts on community outreach and enrollment of under-represented populations.

STUDY SAMPLEWe aim to enroll ~200 men with prostate, and 50 individuals with bladder and 50 with colorectal cancer (Ntotal~300). Individuals will be over 18, need to have access to the Internet, and consent to medical record follow-up, and completion of online surveys (see Table 1). We welcome the opportunity to translate our materials into other languages, including Spanish, Chinese, Tagalog, and Russian. This study will be open to individuals managed anywhere, including UCSF. For the initial pilot, we will not restrict enrollment based on disease status or clinical criteria, and will collect data on such clinical parameters for future planning.

We also welcome the opportunity to collaborate with community partners and other researchers to add other measures that gather data on individual, structural, and environmental barriers to physical activity and healthy nutrition. For example, we may add questions about adverse life course events or utilize tools to map out the communities with regards to how conducive they are to support exercise and healthy food choices.

We are initiating the study in the proposed cancer sites, given the public health burden and our team’s experience. Prostate cancer is the 2nd most common cancer in men worldwide. In US men, it is the most commonly diagnosed cancer and second-leading cause of cancer death, with 164,690 new diagnoses and 29,430 deaths estimated to occur in 2018. There are ~2.8 million men living with prostate cancer in the US. AA men experience the highest burden of prostate cancer worldwide, with 74% higher incidence and twice the mortality compared to whites. 140,250 new cases and 50,630 deaths due to colorectal cancer are estimated to occur in 2018. 1.2 million people live with colorectal in the US (the third most common cancer among US cancer survivors). Bladder cancer is the 4th most common cancer in men, and 81,190 new diagnoses and 17,240 bladder cancer deaths will occur in 2018.

Table 1. Proposed Surveys & Source of Surveys to be Administered on Eureka Platform*

Topic

Survey Source

Socio-Demographics, Smoking

Eureka

Medical History, Family History

CaPSURE & Health Professionals Follow-up Study

Diet, Exercise/Sedentary habits

Harvard cohorts and CHARRED

CAM

CaPSURE

Sleep Quality

Pittsburg Sleep Quality Index 

Memory / Cognition

Nurses’ Health Study

General & Cancer specific QOL

SF-12 & Patient Reported Outcome Measurement Information Systems Depression & Anxiety

Cancer specific QOL & Anxiety

e.g., EPIC-26, QLQ-C30, & MAX-PC

*Each survey will be administered ~annually, though some may be less frequent (e.g., diet asked every 4 years), while others may be more frequent (cancer-specific quality of life, every 6 months). Surveys administration will be staggered such that participants are pinged ~ quarterly.

OUR TEAM - Our team has outstanding experience in recruitment, enrollment, and follow-up of people with cancer, including diverse populations. For each of our initial proposed cancer types, we have an epidemiologist and a clinician co-lead (Drs. June Chan & Peter Carroll, prostate cancer; Drs. Stacey Kenfield & Sima Porten, bladder cancer; Drs. Erin Van Blarigan & Alan Venook, colorectal cancer). We have also engaged leaders in cancer health disparities research, Drs. Rena Pasick and Nynikka Palmer. Drs. Chan, Kenfield, and Van Blarigan are cancer epidemiologists and have led and implemented multiple cohorts and randomized clinical trials of individuals with prostate or colorectal cancer. Drs. Carroll and Venook lead the prostate and gastrointestinal cancer programs (respectively) of the Helen Diller Family Comprehensive Cancer Center (HDFCCC); and each has long-standing experience in clinical trials, patient enrollment, and outcomes research. Dr. Porten specializes in bladder cancer and is the Associate Chair for Diversity & Academic Affairs in the Dept. of Urology. Dr. Pasick has conducted cancer disparities research for ~30 years, including multi-ethnic, multi-lingual studies with AA, Latino, Chinese, Vietnamese, and Filipino adults on cancer screening and genetic counseling for hereditary cancers. Previously, as Director of the UCSF HDFCCC’s Office of Community Engagement, she established a network of 70+ AA churches in four Bay Area counties, leading to changes in church policies and practices related to diet and health. Dr. Nynikka Palmer has a National Cancer Institute (NCI) K01 award to address inequities in quality of care among AAs with prostate cancer, and established and runs a support group for AA men with prostate cancer in Oakland. Drs. Pasick and Palmer co-lead the first of its kind county-wide initiative to eliminate the mortality disparity in prostate cancer among AA men via community-based education and screening and a multiple health system quality collaborative (San Francisco Cancer Initiative, SF CAN). Mr. Ghilamichael Andemeskel is a graduate of the SF BUILD program, former Vice President of the Black Student Union and founder of the first Black Unity Center at San Francisco State University, and is currently an outreach coordinator for Dr. Chan’s clinical studies on prostate cancer. Our team has worked (or is currently working) with the following community leaders: Mr. A. Perkins, former Director of the Alameda County Public Health Dept. and prostate cancer advocate; Mr. M. Shaw, Director of the Alameda Health Department's Urban Male Health Initiative; Mr. S. Rosenfeld, Marin County prostate cancer support group leader; and Drs. B. Breyer and S. Blashko, clinical urology leaders of Zuckerberg San Francisco General Hospital and Highland Hospital, Oakland, respectively. Additionally, thru Mr. Andemeskel’s efforts, our team has recently begun to engage with multiple community partners, including SF CAN Wellness Warriors, American Cancer Society, San Francisco National Association for the Advancement of Colored People, and multiple community organizations focused on addressing systemic issues facing African American communities in Oakland and San Francisco.

FUTURE PLANS - This initial pilot will be supported via philanthropic funds of Drs. Carroll & Chan in the Dept. of Urology. We are committed to launching and sustaining the cohort through 2020 and beyond, by applying for grants from NCI and Dept. of Defense. Build-out of the cohort will be guided by the pilot, though we anticipate expanding the scope of the study through mailings via state cancer registries, collaboration with international health-focused philanthropic organizations such as Movember and Prostate Cancer Foundation (whose leaders have already expressed support for digital advertising), and outreach to community networks.

Comments

Thanks for taking the time to submit. Would it be possible for you to share a 150-word plain language summary of your idea? How would you describe this to your next door neighbor?

Our selection committee has both UCSF and non-UCSF community-based members so a short accessible summary will make it easier for everyone to engage. 

Hi Beth, thank you for this request. We have developed the following "plain language" summary.  Please let me know what you think and if you have any other suggestions/questions.

A common question that people ask after they find out they have cancer is: “What can I do to keep the cancer from coming back?” Our study aims to find answers for the millions of people worldwide who live with cancer. We will use the Internet to collect information on individual characteristics (such as age, race, where people live, who they live with, education, etc), cancer care and other diseases, and about daily life (for example, what people eat, how much they exercise and sleep, if they use any natural products or meditate, etc). If we can enroll a diverse group of people and follow them for several years, we will learn if different lifestyle practices lead to better cancer outcomes. To start, we will enroll people with prostate, bladder, and colorectal cancer. We will share what we learn on our website, for participants and the general public.

Hi Beth - FYI, we have edited the proposal to lead with this plain language summary.

Thanks June.  Eureka is already engaged in this important project, and I agree that engaging community partners would enhance the work.  I understand that this work represents a pilot project that would hopefully lead to additional funding and expanding the scope of the study.  A question - if recruitment goes as you hope through Fall 2020, will you have enough data to answer at least one research question?  If so, what would be the FIRST specific research question you would try to answer?

HI Mark, thank you for the question.

Our initial research questions are focused on feasibility and acceptability of the study platform, and how we can enroll diverse individuals into this digital study. We propose a pilot of ~300 individuals with prostate, bladder, or colorectal cancer, for this first phase, and will focus on recruitment of diverse demographic groups. Thereafter, we plan to attempt to enroll several thousand individuals of each cancer type (starting in 2019-2020 and onwards).

In the short-term (by Fall 2020), I anticipate that we could answer the following important questions on how to improve cancer survivorship: 

  • What lifestyle factors affect overall and cancer-specific quality of life (QOL)?  (This includes questions on how lifestyle may be able to offset side effects of treatment)
    • There are questions we could investigate combining all cancer types, such as: “Are exercise (type, intensity, frequency), meditation, or the usage of other alternative approaches associated with reduced anxiety regarding cancer recurrence?”
    • There are also cancer-type specific QOL questions, e.g, “What specific diet habits, complementary alternative medicine use, or exercise practices are associated with reduced incontinence among individuals with prostate cancer (post-surgery)?”
  • As we aim to enroll a diverse cohort of people with cancer, it would also be of interest to examine which socio-demographic features predict adherence to diet or exercise guidelines for people living with cancer (e.g., American Cancer Society Physical Activity and Nutrition Guidelines for Cancer Survivors). This research may identify opportunities to tailor education, support, and interventions for specific groups of people who may benefit the most from changing diet or exercise practices.

As to which question might we prioritize FIRST, I think it would be of interest to examine what lifestyle practices reduce anxiety regarding cancer recurrence, and if there may be differences by race/ethnicity or culture.

To address questions about diet, exercise, or sleep and the development of cancer recurrence/progression would require more years of follow up, of several thousand people.

Are you looking for community members or UCSF patients or both?  If UCSF patients, are you recruiting through clinic or EHR-based data querying?

Hi Mark -  thank you for the quesiont. We are open to recruiting from both groups you mention; and primarily through EHR based data querying, rather than through live/in-person clinic encounters. Also, we have worked previously with the CTSI on the following types of recruitment methods in other studies - mass mailing to UCSF patients and MyChart messaging to UCSF patients. We'd be interested to pursue both those approaches for this study. We have also received a letter of support from the Greater Bay Area Cancer Registry (Dr. Scarlett Lin Gomez, Director) to obtain case listings and conduct a mass mailing using data from their registry. 

Were there funds allotted for translations in the budget?

What are your plans to test the translations?

How do you plan to promote the study to the non-English communities?

Do you have staff with the language capacity to assist non-English speaking participants?

Were any of the survey sources/instruments validated for the Spanish-, Chinese-, Tagalog- and Russian-speaking populations?

Thank you for raising many excellent points. In this pilot phase, we do not have funds for translations. Our plans have been to first develop and test the study website, online surveys, recruitment procedures, feasibility and acceptability, using English language materials. Subsequently, we plan to develop a larger grant application that includes translation services and bilingual bicultural collaborators. Based on US Census data, we plan to prioritize translation for the most common languages spoken at home -  English, Spanish, Chinese, and Tagalog. With this proposal to eDiverse cohorts, we would be excited to work with collaborators to facilitate quicker adoption of translated materials for the study.

 At this time, we do not have primary staff to assist with non-English speaking subjects, although we have one bilingual member of our research group (Spanish). We understand that one approach for translating survey instruments is to have several multi-lingual individuals translate and back-translate the same surveys (i.e., different individuals translate than those who back-translate), paying attention to both linguistic and cultural appropriateness, then have the two sets of individuals review and reconcile differences together. For certain metrics, construct validity assessment of the translated survey could be done against objective measures (e.g., exercise survey vs. accelerometers or fitness evaluations). We currently do not have resources for conducting such translations or validation studies ourselves, and are interested to learn and collaborate with others on this aspect of the study.

We anticipate that a main way to advertise and recruit participants will be through mass mailing advertisements (paper or email) and social media. When we have multi-lingual study materials ready, we plan to work with different groups on campus to help raise awareness about the study in different languages (e.g., Asian American Research Center on Health, Greater Bay Area Cancer Registry, Urologic Oncology clinics at ZSFGH, SF CAN, Helen Diller Family Comprehensive Cancer Center Office of Community Engagement, etc).

Based on the literature, several of the proposed surveys have been validated in multiple languages:

Pittsburg Sleep Quality Index – Spanish, Chinese, Hebrew, Arabic, Portuguese, etc

PROMIS QOL metrics – Spanish, Chinese

Food Frequency Questionnaire – Spanish

We acknowledge that for some of the surveys, like the diet assessment, both linguistic and cultural appropriateness will be particularly important, and we have considered using additional methods of assessment that would allow more flexibility in responses (e.g., 24-hour diet recalls using the National Cancer Institute ASA24, Automated Self-Administered 24 Diet Dietary Assessment Tool, is available in English, Spanish, and French).

a few questions:

1) how do you see the community advisors helping you with your project? do you have specific ways they can be most helpful? 

2) how do you propose to document pre-diagnosis lifestyle habits in your participants? what will the baseline data on your participants come from?

3) given the diversity of patients you are recruiting, what is your process for identifying important culturally specific lifestyle habits across socio economic status that can influence quality of life? Also, how is spirituality being addressed as part of lifestyle? it is so important to many in our communities.

4) Re: digital divide critique - have you considered or will you be offering patients with a phone?

5) how are/would patients benefitting from with the study? how are you integrating supports/information/resoures within the study? 

6) Re: cancer -- community residents perceive that there are few linguistically accessible supports to the Latin@ community - community residents would like to have more culturally and linguistically appropriate - how do you intend to communicate out the results of such a study and do it in the most user-friendly manner for residents of all communities? 

7) will this study examine African immmigrant communities?  generational differences? 

Thank you for more great questions, and providing us an opportunity to share more about our plans, approaches, and vision for this study. We have tried to address each question individually below. Thanks!

1)    how do you see the community advisors helping you with your project? do you have specific ways they can be most helpful? 

Response: We plan to engage and integrate community advisors into multiple aspects of the study design, planning, implementation, and follow-up. We will be seeking guidance on what data we should collect for different populations, pilot testing our materials and online study experience, developing culturally competent methods for community engagement, and assisting with developing networks for advertising the study for enrollment. We will work with the Helen Diller Family Comprehensive Cancer Center Community Advisory Board (HDFCCC CAB), and Dr. Kim Rhoads, the new Director of the Office of Community Engagement for the HDFCCC.

We will have a pilot phase, including focus groups, interviews, and requests for feedback on study materials and the website/mobile user interface. Community advisors could help us identify early participants who would be more likely to engage and provide constructive feedback.

For the pilot phase and beyond, we anticipate that for some groups, establishing trust through multiple contacts, education, and relationship-building may be needed before one even discusses research participation. We anticipate seeking guidance from community advisors regarding best ways to engage potential participants, frame and promote the study, and solicit feedback on what information different communities would like to view on the website as general “patient education”. Furthermore, community advisors can provide guidance to establish a culturally competent platform and model that aims to minimize any historical or social barriers that might otherwise be overlooked. We recently hired an outreach coordinator specifically to network and build relationships in African American communities of Oakland and San Francisco, to help build partnerships that support ongoing dialogue, general public education about diet/lifestyle/clinical research, and recruitment for our current clinical trials and this proposed study.

 

2)    how do you propose to document pre-diagnosis lifestyle habits in your participants? what will the baseline data on your participants come from?

Response: Baseline data will be obtained through online, validated, surveys. In the future, we may be interested to add a biospecimen collection portion to the study to also examine things like nutrient or oxidative stress or inflammation levels, however that will require a larger grant to support building the infrastructure for multi-site collection/processing. Using online surveys, we will also ask about changes made in diet, exercise, and other lifestyle factors, pre- vs. post-diagnosis, although such questions may be subject to recall bias.

3)    given the diversity of patients you are recruiting, what is your process for identifying important culturally specific lifestyle habits across socio economic status that can influence quality of life? Also, how is spirituality being addressed as part of lifestyle? it is so important to many in our communities.

Response:

As described above, we will work closely with our community advisors on what data we should collect for different populations, and pilot testing our materials and online study experience. This will include requesting guidance on culturally specific lifestyle habits.

In general, we will collect information on residential neighborhood, income (self-reported in categories), education, occupation, and household size to help us examine if there are differences in the effects of lifestyle factors by socio-economic status. After we launch the initial phase of this study, we will have a robust platform for requesting information on other critical aspects of lifestyle (i.e., other than diet, exercise, sleep, CAM, etc), including spirituality, that may influence quality of life and overall health. For example, we have identified the Spiritual Well Being survey, EORTC QLQ‐SWB32 (Vivat B, European J of Ca Care, 2017) as a future module for buildout on the Eureka platform; and we have been approached about adding a survey regarding racism or adverse life course events, depending on the diversity of the population which we are able to recruit.

 

4)    Re: digital divide critique - have you considered or will you be offering patients with a phone?

 

Response: For our initial pilot, we do not have sufficient funds to offer participants a phone, though the study will be available/accessible both by phone, tablet, or computer.  As part of the pilot, we plan to ask individuals about reasons for declining both on our study website and through a mass mailing to a subset of potential participants. While we realize that those who decline may not respond, we will attempt to gather such data for future planning and grant applications.

5)    how are/would patients benefitting from with the study? how are you integrating supports/information/resources within the study? 

Response: As scientists and public health advocates, we are committed to pursuing novel research to extend our knowledge about prevention, while also developing and disseminating tools/resources to the general public. As we have done in the past, we anticipate working with patient advocates to develop new content for community talks and patient guides. Our team has extensive experience making patient-friendly tools (e.g., recommendations, shopping guides, recipe books, magnets, postcards, exercise workbooks, exercise plans, blogs, interviews with experts, recipe of the week, etc) about diet and exercise, as we have done this for several of our intervention trials, at the request of national foundations (e.g., Prostate Cancer Foundation, American Cancer Society), and for distribution on our departmental websites. We have collaborated successfully with Beth Berrean’s group to design these print and web-based materials in the past. Specifically for this study, we plan to distribute similar patient-friendly materials about prevention and wellness on the study website. We anticipate making additional materials targeted at specific groups based on cancer type, as well as preventive health measures appropriate for the general public (i.e., not just cancer survivors).

As an example, we have created several patient-facing, user-friendly lifestyle guides for men living with prostate cancer, which are freely available on our Dept. of Urology website as downloadable PDF’s (https://urology.ucsf.edu/lifestyle-studies ); we also have mass produced print copies of these booklets for distribution in clinic and at patient support groups, etc. They have been very well received and we are consistently asked to share more by providers from our urology clinic and integrative medicine, and our local patient support groups. We have also made graphic magnets to remind men about healthy eating habits for prostate cancer prevention, and are currently working on a general healthy eating/shopping postcard appropriate for a broad audience (i.e., aligning with American Heart Association, American Diabetes Association, American Cancer Association, and our own research recommendations). We plan to have our outreach coordinator (Mr. Ghilamichael Andemeskel) distribute these postcards with our other study advertising materials at community events.

6)    Re: cancer -- community residents perceive that there are few linguistically accessible supports to the Latin@ community - community residents would like to have more culturally and linguistically appropriate - how do you intend to communicate out the results of such a study and do it in the most user-friendly manner for residents of all communities? 

Response: We will harness existing partnerships in diverse communities, to present study results and provide presentations on cancer prevention (and survivorship) and diet/lifestyle recommendations at community events. We look forward to engaging with existing and new community advisors, our outreach coordinator (Mr. Andemeskel), and Drs. Rena Pasick and Nynikka Palmer to develop patient education materials that are culturally and linguistically appropriate.

Drs. Pasick and Palmer specialize in community engaged-research with diverse populations and are part of this collaboration. We will work with them, Dr. Kim Rhoads, and others to obtain feedback on the study from diverse groups (including the Latino community), and disseminate useful information to various community groups, through a mix of live presentations, our website, and as print materials. As summarized above, we plan to create tools that live on the study website, so participants can learn about latest study results or recommendations via email, text messages, or logging in to their study account. We also plan to make hard copy materials summarizing general recommendations, and distribute these at community events with our other study advertisements. Our outreach coordinator attends local events to distribute materials, both in conjunction with other UCSF cooperatives (e.g., SF CAN) or independently. For example, this past summer, he has distributed our study materials at the Oakland Art and Soul, Juneteenth, and First Friday Festivals (events in both Oakland and San Francisco), and at local congregations like Bethel AME and Third Baptist Church in San Francisco. We have also worked to establish partnerships with local health group such as the Oakland based African American prostate cancer support group led by Dr. Nynikka Palmer. He has developed and is continuing to develop partnerships with local faith groups, community organizers, and health coalitions. These efforts provide representatives of the community with access to study information materials and more importantly promote direct engagement, such that they are more empowered to be active decision makers about their lifestyle and health, and the education of their communities.

Our team also regularly provides talks for the general public on diet/lifestyle recommendations (e.g., Drs. Kenfield and Chan recently presented on diet and exercise for cancer prevention at the American Cancer Society Bay Area Policy Forum, sponsored by the Oakland A’s). Additionally, members of our team, including Drs. Palmer and Pasick, and our outreach coordinator (Mr. Ghilamichael Andesmeskel), have experience developing culturally appropriate presentations about clinical research and medicine and presenting at local community churches, health organizations, etc.

Dr. Chan has also been invited to create podcasts on diet and exercise for the Prostate Cancer Foundation, which will be posted/hosted on Facebook; and which could be adapted for posting on our internal dept. and study websites.

We currently are mentoring a diverse group of students (African American, Hispanic/Latino, LGBQTI) who are also interested in engaging different populations in clinical research and integrative medicine, and have expressed an interest in helping with outreach for this study. 

We welcome the opportunity to interface with other colleagues about recommendations on this important point.

 

7)    will this study examine African immigrant communities?  generational differences? 

 

Response: This is a great question and we can add a set of questions to inquire about immigration/ family history of immigration to allow us to study this in the future. 

This is a great project. I have the following questions.

1) Given the amount of community involvement you already have, do you think you need the diversity aspect of Diverse eCohorts (i.e., help with recruitment, retention, appropriate tools for minority populations) or is this primarily to build the tech infrastructure?

2) What are the projected number of minority patients you are planning to recruit? Assuming we can help with Spanish and Chinese, what # of patients from each of those groups?

Hi Tung, Thank you for the clarifying question. We are interested in both the diversity and technology development components of Diverse eCohorts. This project is being launched using internal discretionary funding from the Dept. of Urology, and is not currently supported by a formal grant mechanism.  Thus, any additional support and resources to engage community networks is welcome. While our team has experience conducting community-engaged research, our current part-time outreach coordinator is focused primarily on networking with local African American populations. Fostering parallel networks to provide guidance on outreach to Latino, Asian/Pacific Islander, and other diverse communities would be very welcome.  

With regards to your 2nd question - we propose to enroll approximately 35 African American, 25 Hispanic, and 15 Asian participants. Based on US Census Data, among those who were diagnosed with cancer in 2015, the distribution by race/ethnicity was ~78% White, 10% Black, 7% Hispanic, and 3% Asian, which would correspond to 236, 31, 22, and 9 White, Black, Hispanic, and Asian individuals, respectively, in a population of 300. Thus, we anticipate enrolling a similar/slightly higher proportion of non-white participants (75/300 ~ 25%) than the national distribution.

Thank you for this proposal, and for the important research questions you're working to answer.  Does your team have thoughts about how you would adress incorporating culturally-informed diet and lifestyle practices that are not yet grounded in evidence?  For example: if Latin@ participants are being told that use of a particular plant or vegetable in the diet, like consumption of cactus or aloe vera are beneficial, how does something like that get dealt with in customizing diet information provided for these populations?  Do you review the evidence on these foods, or do you stick to the evidence you're relying on prior to gathering such community perspectives, and merely tailoring the message you've developed in advance? I have the same question for other behaviors, beyond diet.

Hi Mr. Vargas, thank you for your follow-up question. In the past, with regards to our work in prostate cancer, we have done a mix of all that you mention above – we provide summaries based on latest evidence (including studies we have published as well as others), we collect data on new participants to extend the scope of our research, and we have also addressed questions/topics received from our patient advocate/nutrition group. For example, last year when we updated our Diet booklet (https://urology.ucsf.edu/sites/urology.ucsf.edu/files/uploaded-files/attachments/diet_guide_web.pdf the navy blue one, on this page), we collaborated with 3 prostate cancer patient advocates and two registered dieticians with the Helen Diller Family Comprehensive Cancer Center. As a group, we decided which topics to cover/prioritize, either as separate designated sections or under the Frequently Asked Questions area. The patient advocates and the nutritionists played a critical role in identifying topics or questions that may be of interest to our target audience. Currently, our working group is not very diverse (culturally), and it be would great to involve additional community representatives/patient advocates who could help us understand what topics may be of particular interest for different cultural groups/populations. In addition to having the more formal PDF guides available on the website, the study website could have additional sections that addressed a wider scope of topics in a monthly newsletter format or blog. One idea we have discussed internally is having a study nutritionist field questions periodically and keep a running FAQ section, where questions and answers could be filed/tagged/organized to support searching (e.g., to help the item be found if someone google searched it). We look forward to discussing the technical feasibility of this kind resource with the Eureka team. I hope this addresses your questions and thanks again for your interest!

HI again - to clarify, when I wrote "our working group is not very diverse" - I was referring to our patient advocate  committee for prostate cancer that has been intersted in nutrition. We are committed to creating a cohort that will address questions about lifestyle and cancer for diverse populations, and look forward to engaging with more community representatives to ensure the success of this endeavor. thanks!

I appreciate the vastness of the scope, I’m wondering about this as appropriate N for the work that this collaboration is doing. I am also concerned about the tone of “teachable moment”- that approach psychologically does not work in Black/AA communities nor Latinx/ Pacific Islander communities. It also comes across as judgemental and possibly structurally inequitable given health and food access and safety concerns of community dealing with real primary issues that can impact their access, practice and multiple other systemic structural Race issues. How’s night you see shifting to be able to engage without a top down ivory tower university “I know” approach? Also given other factors such as enVirgo mental toxicity etc? 

Dear Dr. LeSarre, Thank you for your thoughtful comments.

Our goal is to initiate a diverse cohort focused on addressing questions about lifestyle factors and cancer survivorship, and which includes under-represented populations. Thank you for pointing out ways to improve our proposal to engage better with diverse communities. I see now how the term “teachable moment” is inappropriate in this context and very much welcome feedback from experts like yourself, who can help me avoid future mis-steps. I have now removed that term, added a basic summary at the beginning of the proposal, and will continue to make edits incorporating feedback before the deadline on Friday. I welcome your thoughts on whether the revised first two paragraphs are better.

Our initial proposed sample size of 300 is the initial pilot phase of the study. The goals of the pilot are to test feasibility and acceptability of the study design, format, and methods in diverse groups. We anticipate revising the study based on the pilot results, and aim to enroll thousands of individuals with different cancer types and of diverse race/ethnicities in the future. The exact numbers for each subgroup will be guided by the recruitment/enrollment experience in the pilot. We have revised the 2nd paragraph to describe this better.

We are interested to partner with community leaders, patient advocates, caregivers, and other stakeholders to create a study that not only collects data for our initial research ideas on diet/exercise/CAM/sleep, but to learn what questions are of most interest to the diverse populations we aim to serve. For example, we may add questions about adverse life course events (including racism and violence) such that one can better study effects on cancer/health. We welcome the opportunity to work with community partners to ensure that our study materials are culturally sensitive, linguistically appropriate, and accessible.

Lastly, thank you for appreciating the “vastness of the scope”! As an epidemiologist, I have benefitted from working with large cohort studies of hundreds of thousands of people that have spanned decades and were started by scientists and participants who came before me. In part, I view the initiation and development of this new study as one way for me to ‘pay it forward’ – to improve public health and medicine for all different types of people, increase knowledge about under-represented populations, and to engage diverse learners in medical and public health professions.

This proposal is an incredible endeavor and could transform how we care for and empower our patients.  

Thank you Dr. Chan, very helpful and thoughtful responses. Given some of your above comments and my repsonses and the goal to: 

In the US, African Americans (AA) have the highest death rate and shortest survival of any racial and ethnic group for most cancer types. Approximately 190,000 AAs are diagnosed with cancer annually. There are extremely limited data on the impact of lifestyle factors on psychosocial and clinical outcomes in AAs with cancer. Thus, focused study on post-diagnostic lifestyle factors, and its influences on cancer outcomes, in particular among AA’s, is warranted.

How might you see shifting design in addition to dialogue around race that you mentioned (and certainly there are longitidunal studies on impact of stress/depression/anxiety and linking them to ongoing experiences of racism), that can address the compounding factor of stress and isolation that can often impact what i was speaking to about "knowledge" not being the deterring/motivating factor in lifestyle changes?

Thank you Dr. Chan, very helpful and thoughtful responses. Given some of your above comments and my repsonses and the goal to: 

In the US, African Americans (AA) have the highest death rate and shortest survival of any racial and ethnic group for most cancer types. Approximately 190,000 AAs are diagnosed with cancer annually. There are extremely limited data on the impact of lifestyle factors on psychosocial and clinical outcomes in AAs with cancer. Thus, focused study on post-diagnostic lifestyle factors, and its influences on cancer outcomes, in particular among AA’s, is warranted.

How might you see shifting design in addition to dialogue around race that you mentioned (and certainly there are longitidunal studies on impact of stress/depression/anxiety and linking them to ongoing experiences of racism), that can address the compounding factor of stress and isolation that can often impact what i was speaking to about "knowledge" not being the deterring/motivating factor in lifestyle changes?

Hi Dr. LeSarre, Thank you for the question. We agree that there could be multiple factors affecting behavior change, in addition to “knowledge” and would be interested in collecting such information for the study, and subsequently identifying ways to address such barriers. We welcome the opportunity to collaborate with community partners and other colleagues who have experience in these areas.  We agree that it would be good to capture data on both individual, structural, and environmental factors that may influence lifestyle habits. For example, we could add measures that capture lived experiences such as micro/macro aggression, stress, or living situations, and ask how these impact lifestyle choices; or, apply geospatial tools to map out the communities with regards to how conducive they are to support exercise and healthy nutrition. Adding such metrics could help identify better what factors act as barriers, and thereby help us provide more evidence regarding how to support healthy lifestyle changes. We have now added this to the proposal. 

Additionally given Black/AA (with a prostate bladder or colo-recatl cancer diagnosis) will typically be of a probably 55+ age range the design will need to be super accessible as this age range is typically not as comfortable with tech and virtual communities and learning. How do you anticipate dealing with this challenge?

We acknowledge that the format of the study may not be as accessible for older adults, which is another reason we aim to test the feasibility of the “format” (Aim 1) and develop methods for enrollment (Aim 2). We have revised the wording of Aim 2 to mention “older adults” as well as “under-represented” groups, and added mention about providing in-person assistance for technology support.

We have long experience conducting “mixed mode” studies and offering both online and paper forms for consenting/surveys. Unfortunately, we currently do not have funds to offer this in the pilot, and thus the pilot is focused on testing feasibility of the digital format, while also collecting data on what percent of individuals would prefer paper/postal mail modes. Such data would help us apply for funding to allow the study to offer both digital and paper data collection methods.

With regards to Aim 2 of the pilot, we have considered several possible ways to create “bridges” or have “facilitators” to help someone enroll in the pilot study digitally, if they are not comfortable with technology. We have several ideas which we look forward to discussing with community leaders/stakeholders, to identify what is more likely to work. For example, we have considered having a team of outreach facilitators (e.g., a combination of volunteers, students, peer navigators/coaches, study coordinators) who could provide more “boots on the ground” support to help show people how to enter the study website and enroll initially. These individuals could provide ongoing periodic assistance in technology support and answer study questions at specified times/places (e.g., having a volunteer who regularly visits the same church, support group, barbershop, café, or community center to help people in-person with a tablet or laptop on hand). We have also considered engaging interested participants to help bring in other people to the study, serving as “peer coaches”. Local peer coaches could also help by identifying places with free Internet or having a “hotspot” with them to create a location with free Internet, temporarily, to facilitate enrollment and survey completion. Some of these ideas require additional funding, and we will be working these  into Fall grant applications and welcome f/b from community partners.

 

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