Breast cancer is the most prevalent type of cancer among Asian American women, and its incidence is increasing [1,2]. Higher survival rates have led to a greater focus on improving cancer survivors’ quality of life [3,4]. Asian American immigrant breast cancer survivors continue to face unique challenges because of cultural and socioecological factors [5,6]. Although they commonly report emotional distress and express the need for social, emotional, and spiritual support [7], they are less likely to seek support from family, friends, or mental health professionals than White Americans [8]. Asian American breast cancer survivors report cultural stigma toward cancer, gender role socialization as caregivers, and fear of burdening family as barriers to seeking support [6-9]. In addition, they lack culturally and linguistically appropriate information to manage their survivorship health care [7,10]. Limited English proficiency also limits survivors’ ability to communicate with health care providers, understand health-related information, and make decisions about survivorship care [7]. Thus, Asian American breast cancer survivors have various informational and psychosocial needs that are not addressed by existing evidence-based interventions.

Psychosocial interventions delivered after the completion of primary oncologic treatment have improved the quality of life of breast cancer survivors [11,12]. A systematic review and meta-analysis of different psychosocial interventions showed improvement in emotional distress, anxiety, depression, and quality of life after treatment [12]. For example, women undergoing educational and nutritional interventions showed fewer depressive symptoms and improved physical functioning at follow-up [13]. Psychosocial interventions (supportive, expressive discussion groups) reduced loneliness, promoted hope, and enhanced the quality of life in women with breast cancer [14]. In addition, women who lacked personal resources (eg, self-esteem) or social support were more likely than those with these resources to show physical health improvements after participating in a psychosocial intervention [15].

Most previous interventions on breast cancer survivorship have been conducted among English-speaking, highly educated White women. Sociocultural differences between White and Asian American immigrant women may limit the applicability of existing interventions to Asian American breast cancer survivors. For example, 50% of Asian Americans do not speak fluent English [16]; however, existing interventions do not address language barriers in communication between patients and health care providers. Moreover, existing interventions do not target cultural factors that affect the quality of life, service use, or support-seeking attitudes among Asian American cancer survivors. Hence, although psychosocial interventions confer significant benefits to health and well-being, existing interventions may not address the specific needs of Asian American breast cancer survivors.

The Joy Luck Academy program was developed for Chinese-speaking breast cancer survivors [17], using a community-based participatory research (CBPR) approach (ClinicalTrials.gov NCT02946697) [18-21]. The Joy Luck Academy includes two components: education and peer mentor support. Each component was chosen based on the needs of this group, including lack of knowledge about breast cancer and survivorship management, feelings of loneliness, lack of emotional support, communication difficulties, and body image concern [22].

The results of a pilot study suggested that Joy Luck Academy has the potential to improve well-being among Chinese American breast cancer survivors [17,23]. Furthermore, qualitative data revealed that Joy Luck Academy reduced perceived stigma and loneliness and increased a sense of belonging by providing a forum for participants to share their experiences with women of similar cultural backgrounds [17]. The pilot study results confirmed that the intervention was feasible and valued by Chinese American breast cancer populations and that the CBPR approach improved the cultural sensitivity of the intervention.

We planned a randomized controlled trial (RCT) to test the health benefits of Joy Luck Academy and identify how and to whom the Joy Luck Academy is effective using a CBPR approach and mixed methods. This study is the first RCT to test a culturally and linguistically sensitive intervention designed to address the informational and emotional needs of Chinese American breast cancer survivors.

The primary aim of this study is to test the health benefits of a culturally sensitive social support program for Chinese American breast cancer survivors (aim 1). We hypothesize that the program will confer health benefits, as indicated by improvements in outcomes. The primary outcome is quality of life; the secondary outcomes are depressive symptoms, fatigue, positive affect, and perceived stress. We also expect that the intervention will normalize diurnal cortisol levels, an exploratory outcome. Secondary objectives include identifying the characteristics of individuals who benefit from the Joy Luck Academy (aim 2) and understanding the underlying mechanisms (aim 3). On the basis of the literature and our pilot study [15,17], we hypothesize that Joy Luck Academy will be more effective for women who lack psychosocial resources, specifically, those with low levels of social support, optimism, and perceived control over illness. We hypothesize that the Joy Luck Academy will increase relatedness need satisfaction and coping self-efficacy and decrease cancer-related perceived stigma, leading to health benefits (ie, mediators of the intervention effect).

We will conduct an RCT in Chinese American breast cancer survivors who have completed primary treatment. Participants will be randomly assigned to the Joy Luck Academy intervention or control group. Health outcomes will be assessed at baseline and immediately after the intervention (7 weeks after baseline) and at 1 and 4 months after completing the Joy Luck Academy. All study materials will be in Chinese.

We will recruit 168 Chinese American breast cancer survivors, as determined by a sample size calculation (described below in Power Analysis section). Experienced researchers and community staff who speak fluent Chinese (Cantonese or Mandarin) will introduce potential participants to the study, screen them for eligibility, and invite them to participate; if they decline to participate, their reasons for declining will be documented. Upon completion of the study, each participant will be given prorated US $180 in gift cards as compensation.

The inclusion criteria were (1) self-identifying as being comfortable speaking Mandarin or Cantonese, (2) women having stage 0 to 3 breast cancer, and (3) having completed primary treatment (surgery, chemotherapy, or radiotherapy) within the previous 36 months.

Participants will be recruited from the Greater Los Angeles area in Southern California. We will identify and recruit potential participants via a community organization (Herald Cancer Association [HCA]) and local advertising. The HCA provides many community services, including providing Chinese-language cancer information brochures. The HCA maintains a large database of primarily Chinese immigrant breast cancer survivors, who registered with the HCA to obtain educational and informational resources. The HCA will contact individuals on their client list, advertise the study in their monthly newsletters, ask for referrals from participants, and promote the study at cancer survivor events. Targeted announcements will be used in the Chinese American community to reach women who are not in the HCA database. The San Gabriel Valley region of Los Angeles County has the largest concentration of Chinese American communities in the United States [24]. Announcements will be distributed to local clinics, doctors’ offices, and other patient services.

We will obtain approval from the human subjects protection committees of the University of Houston (Houston, Texas), the University of Texas MD Anderson Cancer Center (Houston, Texas), and the California Cancer Registry (Sacramento, California) to conduct this RCT. Written informed consent will be required before participation from each participant and will be obtained by the HCA.

Power analysis was based on the primary aim of this trial. Specifically, we calculated the sample size required to detect the effect of Joy Luck Academy on the primary outcome (quality of life at the 4-month follow-up assessment). In our primary analyses, we will use maximum likelihood-type (eg, restricted maximum likelihood) estimation procedures based on all observed data, assuming a missing-at-random mechanism [25]. The pilot study revealed that the Joy Luck Academy had an intermediate or higher effect on improving participants’ quality of life (Cohen d=0.47), depressive symptoms (Cohen d=0.55), and positive affect (Cohen d=0.62). On the basis of a targeted medium effect size of Cohen d=0.47, we estimated that a total sample size of 146 women at the 4-month follow-up would yield 80% power to detect this treatment effect at α=.05 (nQuery Advisor Version 7.0, Statistical Solutions Ltd). Assuming an attrition rate of 10%-20%, the final recruitment goal will range between 162 and 183 at the baseline.

Participants who consent to participate will be randomly assigned to the Joy Luck Academy or control group at an approximate 1:1 ratio. Using minimization—a covariate adaptive randomization approach [26]—we will assign a participant to the intervention or control group by applying a randomization algorithm that will take into account participants’ age, stage of cancer, and time since completing treatment. This covariate information will be obtained by the HCA staff during the participant screening process. Randomization will start 4 weeks before the orientation scheduled start date and continue until the recruitment goal is reached or until 1 week before the start of each cohort study. Only the researcher conducting random assignments and the person who informs participants of their group allocation will be aware of the condition assignment.

Each Joy Luck Academy intervention program will enroll a maximum of 24 participants. We plan to deliver seven Joy Luck Academy programs during the project period. The Joy Luck Academy programs will have the same instructors, lectures, and support materials to ensure the fidelity of programs delivered at different times.

Joy Luck Academy participants will meet for 3.5 hours once a week for 7 consecutive weeks. Each session will begin with a 30-minute breakfast to allow for informal conversations among participants (mentees) and mentors. The meal is followed by a lecture given by the instructors on cancer-related topics and a question-answer session. After the lecture, 15 minutes of physical exercise will be engaged, followed by a 15-minute break. After the break, participants will join class activities and group sharing in the format of a large group sharing led by a Joy Luck Academy program facilitator, a small group sharing led by peer mentors, or a combination of both. The lecture, question-answer, class activities, and group sharing take about 2.5 hours in total.

Joy Luck Academy lecture topics include recognizing the side effects of treatment and differentiating them from the symptoms of cancer recurrence, physical therapy and complementary treatments, stress management, recognizing depression and managing emotional problems, communication with family members, and body image. The Joy Luck Academy instructors are professionals who are experienced in breast cancer treatment and support, including a breast surgeon, a clinical psychologist, a physical therapist, a dietitian, and a beautician. They will give lectures in their areas of expertise and answer the Joy Luck Academy participants’ questions. Some sessions will be audio recorded to determine fidelity to the protocol, lecture plan, and activity objectives.

Each peer mentor will work with 3 to 5 mentees. Peer mentors will lead small group discussions on that week’s topic and share their own experiences with mentees. This setup will encourage and allow mentees to share personal feelings in a relaxed and comfortable setting and receive support and advice. Mentors will also contact mentees once a week during the 7-week program to provide guidance and address remaining concerns. Each participant will be assigned to a volunteer peer mentor who is a breast cancer survivor and speaks a similar Chinese dialect. Mentors will be recruited from graduates of Joy Luck Academy pilot programs. Each potential mentor will be evaluated by the program facilitator based on the potential mentor’s engagement in the program and support of other participants during the program. Mentors will complete a 3-hour training program to gain mentoring skills. The training will be conducted by HCA staff using a standardized manual that was jointly developed by the academic and community teams. The training program focuses on skills in establishing rapport, demonstrating understanding, listening empathically, discussing participants’ concerns, and promoting the sharing of information and feelings. The training also involves lectures, case study presentations, discussions, and role-play activities.

We will use a procedure to maximize attendance and retention recommended by a previous study [27]. Participants will be asked to notify the program facilitator or their assigned mentor in advance if they will be absent. They will be told that, with their permission, the group members will be informed of the reason for their absence to reduce worries and concerns. The mentor will keep copies of the handouts for missing participants and call them within 5 days to briefly discuss the week’s topic and tell them that they can pick up the handouts when they return to class. This should make participants feel that they are cared for by others and that they can catch up and will make them more likely to continue the program. Participants will also be informed that the lectures, recorded in DVD format, will be available for them to view at home so that they will not miss information in the lecture.

Control group participants will undergo usual care and receive information booklets in Chinese that were developed by the American Cancer Society [28]. The booklets cover common issues related to breast cancer, various treatments, and life after treatment, which are similar to the topics covered in the Joy Luck Academy. Control group participants will be informed that they are in the self-study group to read the information booklets on their own to reduce potential anticipation bias and they will have the opportunity to join an in-person study group (Joy Luck Academy) after the assessment at the 4-month follow-up.

All participants’ identification records will be kept confidential and stored in a secure file with password protection. Each participant will be assigned an identification number that will be used on all documents and data files. All protected health information will be removed from the data when it is exported for analyses.