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 SAMPLE – We 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*
Medical History, Family History
CaPSURE & Health Professionals Follow-up Study
Diet, Exercise/Sedentary habits
Harvard cohorts and CHARRED
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.
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