Approximately 1 in 3 of prostate cancer diagnoses are classified as “low risk” and “very low risk” for disease progression and mortality. Active surveillance, that is, closely monitoring the course of disease, is a recommended management option for all men with very low risk and most men with low risk cancer. In the U.S., more than 100,000 men a year are estimated to be candidates for active surveillance, but only 40% of eligible men receive active surveillance. Despite the fact that prostate cancer is the most commonly diagnosed cancer in men among all major racial/ethnic groups, there is very little known about the determinants of active surveillance and outcomes across racial/ethnic groups.
The research questions for this study are:
1) What are provider experiences with and perceptions of racial/ethnic differences in patients’ preferences regarding active surveillance?
2) What are patient perspectives and ethnic/cultural/psychosocial beliefs regarding active surveillance?
3) What is the influence of patient and contextual (family, social networks, institutional/provider, neighborhood) factors on use of active surveillance?
4) What are patient-reported outcomes (PROs), including quality of life and physical, physiological, and psychosocial well-being, at various time points after prostate cancer diagnosis?
To address these questions, the Talking About Prostate Cancer (TAP) study will establish a diverse population-based cohort of low risk prostate cancer patients that can be followed for future research inquiries, including examination of disease progression.This study, conducted within a range of medical care settings, will enable us to understand the factors that drive differences in active surveillance referral and utilization. In identifying vulnerable sub-populations, study results will inform culturally-targeted clinic-level policies and practices regarding patient communication and counseling, and ultimately ensuring that all men, regardless of race/ethnicity or socioeconomic status (SES), have the opportunity to be fully informed about their treatment options and experience optimal wellness as a survivor.
An online engagement and data collection platform would allow this study to recruit and retain the diverse participants that are needed to answer the above research questions. Making data collection more efficient, streamlined, and culturally relevant will promote engagement from participants who are typically underrepresented in research projects. Finally, an online platform would facilitate the development of a diverse population-based cohort for future research studies.
The impact of the project on minority communities will be to: understand the unique factors that affect decision-making about treating prostate cancer; inform culturally-targeted clinic-level policies and practices directed towards improving patient communication and counseling; and ultimately, to support all men diagnosed with prostate cancer to make decisions about their treatment that will reflect the same positive outcomes across all racial/ethnic groups.
This study will include a survey component among both prostate cancer patients and physicians in the Bay Area. We propose to use the Eureka platform only for the patient component of this study, thus, only the methods pertaining to patient participants are described here. Eligible patients will be identified through the Greater Bay Area Cancer Registry (GBACR), a part of the statewide California Cancer Registry and the NCI Surveillance, Epidemiology, End Results (SEER) Program since 1973. Using an early case ascertainment method to identify cases within 6-9 months after diagnosis, eligible patients are those newly-diagnosed with very low risk or low risk first primary invasive prostate cancer, ages 40-79 years and residing in one of the nine Greater Bay Area counties at diagnosis. This age range was selected because it represents 95% of all cases, and treatment decisions are less confounded by comorbidities and life expectancies. We will recruit all non-White ethnic groups and a 20% sample of NH Whites. Of approximately 4,700 cases of invasive prostate cancer reported each year in the catchment region, more than 40% (N approximately 1,900) have very low or low risk disease. These patients include both UCSF patients and non-UCSF patients. We plan to recruit patients who speak English, Spanish, Chinese (Mandarin and Cantonese), and Tagalog.
The main survey constructs are listed in the Table. Tumor characteristics will be ascertained from the GBACR. Most domains will be based on established items, adapted accordingly based on a qualitative phase of the study, which will inform the survey development.
Table. TAP Study patient survey constructs
Outcomes – dependent variables
We will conduct a baseline survey within 2-3 months of diagnosis when the men are making their decision regarding their initial treatment. Follow-up surveys will be administered at 12- and 24-months after the baseline survey (approximately 15- and 27-months after diagnosis), selected to capture relevant clinical events in the trajectory of treatment and surveillance, such as PSA measurement at 6 months and biopsy at 12 months following diagnosis, and to capture changes in PROs.
We currently have a study website available in 3 languages (English, Spanish, Chinese) for patient recruitment (tapstudy.ucsf.edu). The Eureka platform would be an ideal solution for tailoring our website with culturally-relevant content that would encourage participation, easily incorporate electronic consent for this minimal-risk protocol, and provide a stable self-administered survey platform in 4 languages (English, Chinese, Spanish, Tagalog). The Eureka platform would also enable us to offer links to suveys via computers or apps and could be programmed to notify participants when surveys are ready and notify study staff of important data collection issues, completion of surveys, and non-response flags. Simple, tested, stable platforms for this type of research are critical to engaging diverse populations and retaining their participation in the future.
This research will be led by a multi-disciplinary team of collaborators with a productive history of research in prostate cancer, especially focused on disparities. The Principal Investigator, Dr. Scarlett Lin Gomez, Professor in the Department of Epidemiology and Biostatistics (DEB) and Member of the HDFCCC, is a cancer epidemiologist at UCSF with experience in disparities research focusing on multi-dimensional social and cultural determinants of health. Dr. Iona Cheng, Associate Professor in DEB and Member of the HDFCCC, is a molecular epidemiologist whose research focuses on understanding the role of genetic, molecular, lifestyle, and neighborhood factors in relation to cancer risk and outcomes, with much of her research focused on prostate cancer. Dr. Shariff-Marco, Associate Professor in DEB and Member of the HDFCCC, is trained in social and behavioral sciences and conducts epidemiologic and mixed methods research aimed at addressing the role of social determinants of health, including neighborhood determinants, as it relates to cancer disparities in racial/ethnic groups. Dr. Janet Shim is Professor in the Department of Social and Behavioral Sciences at UCSF, and brings expertise in sociology, psychology, qualitative and mixed methods research. Dr. Daphne Lichtensztajn is an epidemiologist with M.D. training, and is well-versed in cancer registry data, particularly clinical and diagnostic data on prostate cancer. Additional study staff at UCSF include Mindy DeRouen, Laura Allen, Debora Oh, and Mei Chin Kuo.
Co-Investigators include urologic oncologists, Drs. James Brooks, Benjamin Chung, and John Leppert, from Stanford School of Medicine, and Drs. Peter Carroll and Matthew Cooperberg from UCSF; Dr. Robert Haile from Cedars-Sinai Medical Center; Weiva Sieh from Mt. Sinai; Qian Lu from MD Anderson; and Dominick Frosch from Palo Alto Medical Foundation Research Institute.
We have assembled a racially/ethnically-diverse 4-member patient advisory group to help with input on our survey measures, recruitment plans and website design. We will work with HDFCCC to engage with community partners to inform communities about the research, encourage participation, and distribute findings that could impact men’s experience of prostate cancer in the future (e.g., information sessions tailored to issues learned from the results of this study).
This study is funded through the National Cancer Institute (R01CA211141) from August 2017-July 2022. The direct cost budget per year is about $500,000 (minus a 17% budget reduction applied by the NCI). The timing for the e-cohort initiative fits in well with our study as we are beginning the qualitative phase of the study and will begin the patient cohort recruitment in early 2019. Per our timeline, we will begin developing the survey for the patient cohort in upcoming months.
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