Barriers to Recruitment and Adherence in a Randomized Controlled Diet and Exercise Weight Loss Intervention Among Minority Breast Cancer Survivors.

Minority recruitment to cancer trials is low and there are limited data on minority adherence to lifestyle modification interventions. We examined factors related to recruitment and adherence to a pilot weight loss intervention among Hispanic and black breast cancer survivors. Participants completed a detailed screening interview to assess barriers to enrollment. An index was created to assess adherence at 6 months. 112 potentially eligible women were identified; 66 consented and completed a screening interview. After screening, 9 were ineligible; 15 opted to not enroll; and 42 were randomized. Among eligible women, earlier stage at diagnosis, treatment type, and negative beliefs related to exercise and diet after diagnosis were negatively associated with study enrollment (P < 0.05). Self-reported barriers to adherence included fatigue, family responsibilities, illness, work, transportation, and negative perceptions of exercise and diet. Results from this study emphasize the need to adapt recruitment and adherence strategies to address these factors.

Long-term Diet and Biomarker Changes after a Short-term Intervention among Hispanic Breast Cancer Survivors: The ¡Cocinar Para Su Salud! Randomized Controlled Trial.

BACKGROUND: Among Hispanic breast cancer survivors, we examined the long-term effects of a short-term culturally based dietary intervention on increasing fruits/vegetables (F/V), decreasing fat, and changing biomarkers associated with breast cancer recurrence risk. METHODS: Spanish-speaking women (n = 70) with a history of stage 0-III breast cancer who completed treatment were randomized to ¡Cocinar Para Su Salud! (n = 34), a culturally based 9-session program (24 hours over 12 weeks, including nutrition education, cooking classes, and food-shopping field trips), or a control group (n = 36, written dietary recommendations for breast cancer survivors). Diet recalls, fasting blood, and anthropometric measures were collected at baseline, 6, and 12 months. We report changes between groups at 12 months in dietary intake and biomarkers using 2-sample Wilcoxon t tests and generalized estimating equation (GEE) models. RESULTS: At 12 months, the intervention group compared with the control group reported higher increases in mean daily F/V servings (total: +2.0 vs. -0.4; P < 0.01), and nonsignificant decreases in the percentage of calories from fat (-2.2% vs. -1.1%; P = 0.69) and weight (-2.6 kg vs. -1.5 kg; P = 0.56). Compared with controls, participants in the intervention group had higher increases in plasma lutein (+20.4% vs. -11.5%; P < 0.01), and borderline significant increases in global DNA methylation (+0.8% vs. -0.5%; P = 0.06). CONCLUSIONS: The short-term ¡Cocinar Para Su Salud! program was effective at increasing long-term F/V intake in Hispanic breast cancer survivors and changed biomarkers associated with breast cancer recurrence risk. IMPACT: It is possible for short-term behavioral interventions to have long-term effects on behaviors and biomarkers in minority cancer patient populations. Results can inform future study designs. Cancer Epidemiol Biomarkers Prev; 25(11); 1491-502. ©2016 AACR.

Barriers and facilitators to recruitment to a culturally-based dietary intervention among urban Hispanic breast cancer survivors.

PURPOSE: The purpose of this study was to understand factors related to recruitment to behavioral intervention trials among Spanish-speaking urban Hispanic breast cancer (BC) survivors. METHODS: Potentially eligible Hispanic BC survivors were recruited from the Columbia University Breast Oncology Clinic, signed informed consent, and completed a screening interview on demographics, medical history, acculturation (Short Acculturation Scale for Hispanics), quality of life (QOL), and perceived benefits/risks of research participation. Trial eligibility criteria included stage 0-III BC, completion of adjuvant treatment, Hispanic, fluency in Spanish, willing to be randomized to active arm (9-session in-person culturally-based ¡Cocinar para su salud! dietary modification program) or control arm (written materials). We compared characteristics between eligible women who did and did not enroll in the trial. RESULTS: 102 women completed the screening interview and were eligible to participate. Overall mean age was 57.3 ± 9.5 years, mean time since diagnosis was 3.4 ± 2.1 years, 71% reported annual household income <$15,000 and mean acculturation index score was 1.6 ± 0.6 (scale 1-5, low-high). Of the 102 women, 70 enrolled and 32 declined participation. Reasons stated for non-participation included lack of interest in dietary change, illness, and work constraints. Compared to women who enrolled, women who did not enroll were less likely to be employed (P=0.03) and more likely to only read/speak Spanish (P=0.02). Compared to women who enrolled, non-enrollers were more likely to state that research is costly to participants (P=0.03). CONCLUSION: Lower participation was associated with unemployment, monolingualism, and the perception that research is costly to participants. Future behavioral intervention trials among minority BC survivors need to account for these and other factors that may be related to trial participation.

¡Cocinar Para Su Salud!: Randomized Controlled Trial of a Culturally Based Dietary Intervention among Hispanic Breast Cancer Survivors.

BACKGROUND: There is a need for culturally relevant nutrition programs targeted to underserved cancer survivors. OBJECTIVE: Our aim was to examine the effect of a culturally based approach to dietary change on increasing fruit/vegetable (F/V) intake and decreasing fat intake among Hispanic breast cancer survivors. DESIGN: Participants were randomized to Intervention and Control groups. Diet recalls, detailed interviews, fasting blood, and anthropometric measures were collected at baseline, 3, 6, and 12 months. PARTICIPANTS/SETTING: Hispanic women (n=70) with stage 0 to III breast cancer who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012. INTERVENTION: The Intervention group (n=34) participated in ¡Cocinar Para Su Salud!, a culturally based nine-session (24 hours over 12 weeks) intervention including nutrition education, cooking classes, and food-shopping field trips. The Control group (n=36) received written dietary recommendations for breast cancer survivors. MAIN OUTCOME MEASURES: Change at 6 months in daily F/V servings and percent calories from total fat were the main outcome measures. STATISTICAL ANALYSES: Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3 and 6 months. RESULTS: Baseline characteristics were the following: mean age 56.6 years (standard deviation 9.7 years), mean time since diagnosis 3.4 years (standard deviation 2.7 years), mean body mass index (calculated as kg/m(2)) 30.9 (standard deviation 6.0), 62.9% with annual household income ≤$15,000, mean daily servings of all F/V was 5.3 (targeted F/V 3.7 servings excluding legumes/juices/starchy vegetables/fried foods), and 27.7% of daily calories from fat. More than 60% in the Intervention group attended seven or more of nine classes, with overall study retention of 87% retention at 6 months. At month 6, the Intervention group compared with Control group reported an increase in mean servings of F/V from baseline (all F/V: +2.0 vs -0.1; P=0.005; targeted F/V: +2.7 vs +0.5; P=0.002) and a nonsignificant decrease in percent calories from fat (-7.5% vs -4.4%; P=0.23) and weight (-2.5 kg vs +3.8 kg; P=0.22). CONCLUSIONS: ¡Cocinar Para Su Salud! was effective at increasing short-term F/V intake in a diverse population of Hispanic breast cancer survivors.

¡Cocinar Para Su Salud!: Randomized Controlled Trial of a Culturally Based Dietary Intervention among Hispanic Breast Cancer Survivors.

BACKGROUND: There is a need for culturally relevant nutrition programs targeted to underserved cancer survivors. OBJECTIVE: Our aim was to examine the effect of a culturally based approach to dietary change on increasing fruit/vegetable (F/V) intake and decreasing fat intake among Hispanic breast cancer survivors. DESIGN: Participants were randomized to Intervention and Control groups. Diet recalls, detailed interviews, fasting blood, and anthropometric measures were collected at baseline, 3, 6, and 12 months. PARTICIPANTS/SETTING: Hispanic women (n=70) with stage 0 to III breast cancer who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012. INTERVENTION: The Intervention group (n=34) participated in ¡Cocinar Para Su Salud!, a culturally based nine-session (24 hours over 12 weeks) intervention including nutrition education, cooking classes, and food-shopping field trips. The Control group (n=36) received written dietary recommendations for breast cancer survivors. MAIN OUTCOME MEASURES: Change at 6 months in daily F/V servings and percent calories from total fat were the main outcome measures. STATISTICAL ANALYSES: Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3 and 6 months. RESULTS: Baseline characteristics were the following: mean age 56.6 years (standard deviation 9.7 years), mean time since diagnosis 3.4 years (standard deviation 2.7 years), mean body mass index (calculated as kg/m²) 30.9 (standard deviation 6.0), 62.9% with annual household income ≤$15,000, mean daily servings of all F/V was 5.3 (targeted F/V 3.7 servings excluding legumes/juices/starchy vegetables/fried foods), and 27.7% of daily calories from fat. More than 60% in the Intervention group attended seven or more of nine classes, with overall study retention of 87% retention at 6 months. At month 6, the Intervention group compared with Control group reported an increase in mean servings of F/V from baseline (all F/V: +2.0 vs -0.1; P=0.005; targeted F/V: +2.7 vs +0.5; P=0.002) and a nonsignificant decrease in percent calories from fat (-7.5% vs -4.4%; P=0.23) and weight (-2.5 kg vs +3.8 kg; P=0.22). CONCLUSIONS: ¡Cocinar Para Su Salud! was effective at increasing short-term F/V intake in a diverse population of Hispanic breast cancer survivors.