Information is needed on implementation processes involved in translating evidence-based interventions (EBIs) into health disparity communities. In an RCT, Nuevo Amanecer, a cognitive-behavioral stress management (CBSM) program delivered by breast cancer survivors (compañeras) in community settings to Spanish-speaking Latina breast cancer survivors, was effective in improving quality of life and decreasing breast cancer concerns and depressive and bodily symptoms. Using mixed methods, we evaluated the processes of implementing Nuevo Amanecer. Program delivery was assessed by direct observation. Treatment receipt was assessed by participants' mastery and homework completion. Perceived benefits, quality, ease of use, usefulness of components, and suggested improvements were evaluated through participant surveys and semi-structured interviews of participants and compañeras. Eighty percent of women completed six or more of eight sessions. Observer ratings of program delivery indicated compañeras demonstrated fidelity 80-90% of the time for three components (e.g., following the manual), but only 10% for two components (e.g., modeling skills). Regarding treatment receipt, most participants completed all homework. Knowledge and skills mastery was high (mostly >85%). In program evaluations, 93% indicated the program helped them cope with breast cancer "quite a bit/extremely." Participants reported improved self-management skills and knowledge. Suggested improvements were to add more sessions to practice cognitive-behavioral coping skills and simplify exercises and homework. We conclude that CBSM programs can be delivered in community settings by trained peers with high fidelity, acceptability, and perceived usefulness. Results provided some areas where the program could be improved. Our rigorous evaluation illustrates methods for evaluating processes of translating EBIs for community implementation.

Trial registration

NCT01383174 (ClinicalTrials.gov).

Cancer self-efficacy (CSE) and spiritual well-being (SWB) have been associated with better self-rated health (SRH) among breast cancer survivors (BCS), but have not been well studied among Latina BCS (LBCS). Multivariate logistic regression analyses of secondary data from a cross-sectional population-based telephone survey of 330 LBCS explored relationships of language acculturation, CSE, and SWB subdomains of inner peace and faith with SRH. English proficiency was associated with SRH, independent of other covariates (OR=2.26, 95% CI 1.15, 4.45). Cancer self-efficacy attenuated this effect and was positively associated with SRH (OR=2.24, 95% CI 1.22, 4.10). Adding inner peace (a SWB subscale) attenuated the association of CSE and SRH (OR=1.67, 95% CI 0.88, 3.18). Inner peace remained associated with SRH (OR= 2.44, 95% CI 1.30, 4.56), controlling for covariates. Findings support the importance of a sense of inner peace and control over breast cancer to LBCS’ perceived health.

Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA^1-3. As these patients often have limited English proficiency^4-7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient's primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.