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Protocol for a Randomized Controlled Trial of a Culturally Sensitive Social Support Intervention for Chinese American Breast Cancer Survivors: The Joy Luck Academy (Preprint)


 BACKGROUND
 Breast cancer is the most prevalent cancer among Asian American women. Chinese American immigrant breast cancer survivors face unique challenges due to cultural and socio-ecological factors. They report emotional distress and the need for social, emotional, and spiritual support. However, culturally and linguistically appropriate information for managing their survivorship health care is often unavailable.
 
 
 OBJECTIVE
 To improve health outcomes for this underserved and understudied population, we developed, designed and launched a randomized controlled trial to test the health benefits of a culturally sensitive social support intervention (Joy Luck Academy [JLA]). In this paper, we describe the research protocol.
 
 
 METHODS
 Using a community-based participatory research approach, this randomized controlled trial will enroll Chinese-speaking stage 0-III breast cancer survivors who have completed treatment within the previous 36 months. We will randomly assign 164 participants to the intervention or a control group. The intervention arm will attend seven 3.5-hour weekly peer mentor and educational sessions. The control group will receive educational information. We will assess health outcomes at baseline, immediately after the JLA, and at 1- and 4-month follow-ups. The primary outcome is quality of life, as measured by the Functional Assessment of Cancer Therapy. Secondary outcomes include depressive symptoms, positive affect, fatigue, and perceived stress. We will also explore how the intervention influences cortisol levels. To identify how and in whom the program is effective, we will measure social and personal resources and theorized mechanisms and perform qualitative interviews with a subsample of participants to enhance the interpretation of quantitative data.
 
 
 RESULTS
 Recruitment began in February 2015, and data collection was completed by February 2019. We expect to complete data management by July 2021. Study results are projected to be published in 2022.
 
 
 CONCLUSIONS
 If the JLA is demonstrated to be effective, it may be easily disseminated as an intervention for other groups of Asian American immigrant breast cancer survivors; similar programs could be integrated into other diverse communities.
 
 
 CLINICALTRIAL
 ClinicalTrials.gov Identifier: NCT02946697
