Randomized controlled trial of Nuevo Amanecer: A peer-delivered stress management intervention for Spanish-speaking Latinas with breast cancer

• Published in: Clinical trials (London, England) England), 2014-04, Vol.11 (2), p.230-238
• Main Authors: Nápoles, Anna M, Santoyo-Olsson, Jasmine, Ortiz, Carmen, Gregorich, Steven, Lee, Howard E, Duron, Ysabel, Graves, Kristi, Luce, Judith A, McGuire, Peggy, Díaz-Méndez, Marynieves, Stewart, Anita L
• Format: Article
• Language: English
• Subjects: Adult; Breast cancer; Breast Neoplasms - psychology; Clinical trials; Cognitive therapy; Cognitive Therapy - methods; Community-Based Participatory Research - methods; Female; Health Status Disparities; Hispanic Americans - psychology; Hispanic people; Humans; Patient Selection; Peer Group; Randomized Controlled Trials as Topic - methods; Stress; Stress, Psychological - therapy
• ISSN: 1740-7745; 1740-7753
• DOI: 10.1177/1740774514521906

Background Latinas with breast cancer suffer symptom and psychosocial health disparities. Effective interventions have not been developed for or tested in this population. Purpose We describe community-based participatory research methods used to develop and implement the Nuevo Amanecer program, a culturally tailored, peer-delivered cognitive-behavioral stress management intervention for low-income Spanish-speaking Latinas with breast cancer, and unique considerations in implementing a randomized controlled trial to test the program in community settings. Methods We applied an implementation science framework to delineate the methodological phases used to develop and implement the Nuevo Amanecer program and trial, emphasizing community engagement processes. Results In phase 1, we established project infrastructure: academic and community co-principal investigators, community partners, community advisory board, steering committee, and funding. In phase 2, we identified three program inputs: formative research, a community best-practices model, and an evidence-based intervention tested in non-Latinas. In phase 3, we created the new program by integrating and adapting intervention components from the three sources, making adaptations to accommodate low literacy, Spanish language, cultural factors, community context, and population needs. In phase 4, we built community capacity for the program and trial by training field staff (recruiters and interventionists embedded in community sites), compensating field staff, and creating a system for identifying potential participants. In phase 5, we implemented and monitored the program and trial. Engaging community partners in all phases has resulted in a new, culturally tailored program that is suitable for newly diagnosed Latinas with breast cancer and a trial that is acceptable and supported by community and clinical partners. Lessons learned Engagement of community-based organizations and cancer survivors as research partners and hiring recruiters and interventionists from the community were critical to successful implementation in community settings. Having culturally and linguistically competent research staff with excellent interpersonal skills facilitated implementation. Facilitating and maintaining excellent communication among community partners was imperative to troubleshoot implementation issues. Randomization was challenging due to community concerns about assigning women to a control group. Patient privac