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Background: Black men exhibit a high prevalence of vitamin D deficiency as well as a higher incidence of prostate cancer and higher mortality rates from prostate cancer than Whites. There are few data about the effect of vitamin D3 (cholecalciferol) supplementation on prostate-specific antigen (PSA) in healthy Black men. Methods: During three winters from 2007 to 2010, 105 Black men (median age, 48.9 years) of Boston, MA were randomized into a four-arm, double-blind trial for 3 months of placebo, 1,000, 2,000, or 4,000 U of vitamin D3. At baseline and 3 months, free and total PSA was measured. Results: With vitamin D supplementation, no significant differences in free and total PSA were observed; free PSA, −0.0004 ng/mL (P = 0.94) and total PSA, −0.004 ng/mL (P = 0.92) for each additional 1,000 U/d of vitamin D3. Conclusion: Within an unselected population of healthy Black men without a cancer diagnosis, we found no effect of vitamin D supplementation on free or total PSA. Impact: These findings support prior findings of no change in PSA with vitamin D supplementation and emphasize the need for new methods to assess the influence of vitamin D supplementation on prostate cancer prevention. Cancer Epidemiol Biomarkers Prev; 23(9); 1944–7. ©2014 AACR.

The National Cancer Institute's (NCI) Cancer Centers Program has provided a critical infrastructure for discovery related to the causes, prevention, and treatment of cancer. This program spends more than $200 million annually to fund 39 comprehensive cancer centers in 24 states. The substantial

Purpose: To determine if adult survivors of childhood acute lymphoblastic leukemia (ALL) are less active (and more inactive) than the general population and to identify modifying factors. Patients and Methods: Physical activity was assessed by self-report in 2,648 adult survivors of the Childhood Cancer Survivor Study. Participants in the Behavioral Risk Factor Surveillance System (BRFSS) survey administered through the Centers for Disease Control and Prevention (CDC) were used as a comparison group. Results: Survivors had a mean age of 28.7 years (range, 18.0-44.0 years) and were a mean of 23.1 years from their cancer diagnosis (range, 16.0-33.8 years). In multivariate models, ALL survivors were more likely to not meet CDC recommendations for physical activity [odds ratio (OR), 1.44; 95% confidence interval (95% CI), 1.32-1.57] and more likely to be inactive (OR, 1.74; 95% CI, 1.56-1.94) in comparison with the BRFSS general population. Survivors treated with >20-Gy cranial radiotherapy were at particular risk. Compared with BRFSS participants and adjusted for age, race, and ethnicity, survivors were more likely to not meet CDC recommendations (females: OR, 2.07, 95% CI, 1.67-2.56; males: OR, 1.43, 95% CI, 1.16-1.76) and more likely to be inactive (females: OR, 1.86; 95% CI, 1.50-2.31; males: OR, 1.84; 95% CI, 1.45-2.32). Conclusions: Long-term survivors of childhood ALL are less likely to meet physical activity recommendations and more likely to report no leisure-time physical activity in the past month. This level of inactivity likely further increases their risk of cardiovascular disease, osteoporosis, and all-cause mortality. (Cancer Epidemiol Biomarkers Prev 2007;16(7):1356–63)

Purpose: We explored change in complementary and alternative medicine (CAM) use by unaffected women and cancer survivors from enrollment into a randomized BRCA1/2 testing program to CAM use 1 year following results disclosure. Methods: A cohort of 243 high-risk women completed questionnaires at enrollment into a BRCA1/2 randomized trial and 1 year post results disclosure. Uses of several CAMs for cancer prevention were explored, including ingestible, behavioral, and physical modalities. Assessment of the change in CAM use from baseline to 1 year follow-up was conducted using a repeated self-administered questionnaire. Correlates of the number of CAMs used at 1 year were explored using multivariable linear regression models. Results: Among the subset of women who changed their CAM behavior from enrollment to 1 year following BRCA1/2 results disclosure, there was a significantly higher proportion who changed from no CAM use to CAM use among the overall cohort (P = 0.01), among women without cancer at enrollment (P = 0.003), among women found to be BRCA1/2 carriers (P = 0.03), and among women randomized to the genetic counseling intervention arm of the study (P = 0.009). Number of CAMs used at 1 year was positively associated with number of CAMs used at baseline, sunscreen use, and BRCA1/2 mutation status. Conclusion: High-risk women who have received BRCA1/2 counseling and testing frequently adopt new CAM use in the first year after learning their genetic status. Mutation carriers frequently initiate CAM use after learning their genetic status as part of their cancer preventive regimen. Further studies are warranted to determine the efficacy of CAM-related strategies for cancer prevention. (Cancer Epidemiol Biomarkers Prev 2006;15(1):70–5)

Background: This report examines the outcome data for Project PREVENT, a two-site randomized control trial designed to reduce behavioral risk factors for colorectal cancer among individuals who have been diagnosed with adenomatous colon polyps. Methods: The study sample included 1,247 patients with recent diagnosis of adenomatous colorectal polyps. Within 4 weeks following the polypectomy, participants completed a baseline survey by telephone, and were randomized to either Usual Care (UC) or the PREVENT intervention, which was designed to target multiple risk factors. The intervention consisted of a telephone-delivered intervention plus tailored materials, and focused on the six primary behavioral risk factors for colorectal cancer, including red meat consumption, fruit and vegetable intake, multivitamin intake, alcohol, smoking, and physical inactivity. Results: Participation in the PREVENT intervention was associated with a significantly greater reduction in prevalence of multiple risk factors for colorectal cancer compared with UC. Only about one third of UC participants dropped any risk factors during the study period, compared with almost half of the PREVENT participants. PREVENT participants were also significantly more likely to change more than one behavior than UC participants. Conclusions: The PREVENT intervention was effective in helping patients change multiple risk factors. These results provide further support that more comprehensive interventions that move beyond emphasis on a single risk factor are acceptable to patient populations, can result in improvements, and are cost effective.

Purpose: The purpose of this abstract is to describe the recruitment and retention success of a double-blind, randomized-controlled vitamin D supplementation trial enrolling African American (AA), English-speaking participants between the ages of 30 and 80 in the Boston area. Background: This study addresses the critical areas of cancer prevention and racial disparities by defining the optimal dose of vitamin D supplementation in AAs needed for future large intervention efforts in the prevention of colorectal cancer. AAs are at higher risk of colorectal and other gastrointestinal cancers, and compelling evidence suggests that the high rates of hypovitaminosis D in AAs may possibly account for this disparity in cancer incidence. Although the optimal dose of supplemental vitamin D needed to achieve adequate levels of plasma 25(OH)D is unknown in virtually all populations, there is a critical need to define doses of oral vitamin D supplementation in AAs that will achieve a sufficient level of plasma 25(OH)D before vitamin D chemoprevention studies are initiated. Study subjects were randomized to placebo, 1000 IU, 2000 IU, or 4000 IU of vitamin D3 per day to determine the minimum dose of vitamin D needed to achieve an optimal level. Supplementation occurred during the winter months, to reduce sun exposure. After 3 months of supplementation, plasma levels of 25(OH)D are determined and compared to baseline levels. We also assessed vitamin D levels 3 months post supplementation. Methods: The recruitment goal was to enroll 320 participants, including100 men, into the study. A 3-phase eligibility and consent process was used to reach this goal. 1) Only people who were AA, English-speaking, and 30-80 years old were approached to participate in the study. 2) Among these individuals, basic nonclinical eligibility criteria were assessed. 3) Primary care physicians of the remaining individuals were contacted to assess clinical eligibility. Targeted recruitment efforts focused on obtaining individuals who met the first-phase eligibility criteria. Potential participants were identified at public housing sites, faith-based organizations, community organizations, and through participant referrals. To encourage retention, a case-manager approach was implemented and research assistants made biweekly phone calls and monthly pill bottle exchange visits with participants. Results: Through our recruitment efforts, we consented 572 individuals and exceeded our recruitment goals with 329 participants enrolled in the study, including 107 men. During year 1, with 2.5 months of recruitment, we enrolled 46 participants. During years 2 and 3 with 6 months of recruitment each year, we enrolled 166, and 117 participants, respectively. Retention for the 3-and 6-month assessment was 90.1 % and 87.4%, respectively. Conclusions: The number of individuals needed to be approached was about twice the desired amount of participants to be enrolled in the study. The design of this study posed many challenges for recruitment and retention; however, through collaborations with community-based organizations and biweekly contact with study participants, we were able to surpass our goals. Our strategies and lessons learned are relevant to other researchers conducting research in a population, such as this one, that has historically been challenging to recruit and retain into clinical studies. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A43.