Background

Latinos are underrepresented in biomedical research, particularly biomarker research, yet they constitute the nation's largest ethnic/racial minority. Optimal methods for obtaining biospecimens for biomarker research among Latinos need to be identified. To minimize barriers and enhance participation, this study developed and tested tailored strategies for collecting biomarkers of chronic stress and premature aging among Spanish-speaking Latina breast cancer survivors.

Methods

This study used a community-based participatory approach and selected hair and saliva as noninvasive biospecimens to assess telomere length, the cortisol awakening response (CAR), and hair cortisol concentration. We developed bilingual multimedia instructional materials, and community health workers assisted in collections. Telephone surveys assessed willingness to participate in future studies, barriers to sample collection, and recommendations for improving the strategies.

Results

A total of 103 participants were recruited over 18 months from two rural sites in California, and 88 were retained at 6-month follow-up. At baseline, rates of donating salivary DNA for telomere length measurement, saliva for CAR analysis, and hair for cortisol concentration were 98%, 89%, and 52%, respectively. At follow-up, rates were 83%, 76%, and 55%, respectively. The majority of participants reported being very willing to provide hair (72%) or saliva (74%) for future studies.

Conclusions

Our results support the feasibility of including minorities in biomedical research. We report excellent rates of saliva collection when community partners are engaged in the process, and when patient-centered and culturally tailored recruitment methods are implemented.

Impact

The development of methods to facilitate the inclusion of minorities in biomedical research is critical to eliminate racial/ethnic health disparities.

Objectives

Adapt a cognitive-behavioral stress management program (Nuevo Amanecer or NA) to be generalizable to rural, low literacy Spanish-speaking Latinas with breast cancer survivors at all phases of survivorship.

Methods

Apply the Transcreation Framework, a community-engaged translational model, to develop the adapted program (Nuevo Amanecer or NA-II), design a randomized controlled trial for community settings, identify recruiters and interventionists, and recruit participants into the trial.

Results

Adaptations included expanding the program from eight to ten weeks, simplifying materials, and increasing skills practice. We added stress management videos, healthy lifestyles information, and survivorship information. Interventionists were trained Latina breast cancer survivors. All core components of NA were retained in NA-II including managing the impact of cancer, information on breast cancer and its treatment, finding cancer information, getting support, managing thoughts, stress management techniques, and setting goals. Participants receive a program manual. Each session includes a review of that week’s content using the manual, practicing a stress-management skill, setting a specific goal, and reviewing videos. Spanish-speaking Latinas with non-metastatic breast cancer were recruited by community recruiters. Of 231 women approached, 24% refused, 10% were ineligible, and 153 (66%) were randomized to the intervention or a wait-list control group. The sample was vulnerable: 69% had < high school education, more than half had only Medicaid or no insurance, 91% was foreign born, and 48% reported financial hardship in the past year.

Conclusions

Applying the Transcreation Framework to engage stakeholders in designing community-based RCTs enhanced congruence with community contexts and recruitment of this vulnerable population.

Background

An often heard and justifiable concern of ethnic minorities is related to researchers' lack of attention to sharing the results of a study with participants after the study has concluded. Few studies have examined the effects of returning overall study results on participants' attitudes, especially among populations underrepresented in research. Among Latina research participants, providing a summary of study results could enhance participation in research. We assess Latina breast cancer survivors' reactions to receiving study results and their attitudes about participating in future studies.

Methods

For this cross-sectional survey study, all women who had participated in two behavioral randomized controlled trials (RCTs) were mailed a letter summarizing the study results (using written and graphic formats) and a questionnaire assessing problems and understanding the results, importance of sharing results, willingness to participate in future studies, and format preferences for receiving the results. A postage-paid envelope for returning the completed questionnaire was included. Logistic regression examined the associations of age, education, and rural/urban residence on format preferences and willingness to participate. The survey sample consisted of 304 low-income, predominantly Spanish-speaking Latina breast cancer survivors (151 from urban and 153 from rural communities) who had participated in two RCTs testing a stress management program designed for Latina breast cancer survivors.

Results

Ninety-two women returned the questionnaires (30.3%). Most of the women (91.1%) indicated that they had no trouble understanding the results of the study, and 97% agreed that it is very/extremely important for researchers to share the study result with the participants. The majority (60.2%) reported that receiving the results increased their willingness to participate in future studies. About half (51.7%) did not have a format preference, 37.4% preferred written summaries, and 10.9% preferred graphs.

Conclusions

This study is an important first step to understanding the impact of returning study results among a population that is underrepresented in research. Returning the results of studies and understanding the impact of doing so is consistent with maintaining community involvement in all phases of research. The findings suggest that sharing aggregate research results in simple language yields few problems in participants' understanding of the results and is viewed as important by participants.

Trial registration

ClinicalTrials.gov NCT02931552 Date registered: October 13, 2016 and NCT01383174 Date registered: June 28, 2011.

Objective

We report results of a community-based multisite, randomized controlled trial of Nuevo Amanecer (NA-II), a 10-week stress management program for rural, low literacy Latina breast cancer survivors.

Methods

Trained peers delivered NA-II to Spanish-speaking Latinas with non-metastatic breast cancer in three rural communities. Women were randomized to receive the program immediately or wait 6 months. Assessments were conducted at baseline, 3 months, and 6 months. Primary outcomes were breast cancer-specific quality of life domains; secondary outcomes included general distress symptoms and stress management skills. Intention-to-treat analyses using repeated-measures linear regression models estimated changes in slope between groups.

Results

Of 153 participants (76 randomized to intervention, 77 to control group), 92% were retained at 6 months. Mean age was 54.8 years (SD = 10.5); 80% had less than high school education. There were no statistically significant treatment × time effects on quality of life. Compared to women in the control group, intervention group women reported greater improvements in anxiety at 6 months (-0.20 vs -0.02, P = .049; range 0-4) as well as three stress management skills: relaxation at 3 months (+0.98 vs -0.07, P < .0001; range 0-4) and 6 months (+0.82 vs +0.04, P < .001), awareness of tension at 3 months (+0.31 vs -0.19, P < .01; range 0-4) and 6 months (+0.29 vs -0.11, P < .05), and coping confidence at 3 months (+0.12 vs -0.23, P < .01; range 0-4).

Conclusions

Stress management programs delivered by trained peers in rural community settings can reduce anxiety and improve stress management skills among Latina breast cancer survivors.