A Culturally Sensitive Social Support Intervention
Overview
This study is a randomized controlled trial (RCT) to assess the impact of a culturally based social support program (i.e. Joy Luck Academy, JLA) among Chinese American breast cancer survivors.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Supportive Care
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: August 31, 2025
Detailed Description
This study is a randomized controlled trial (RCT) to test the health benefits of an education and peer mentor support intervention. Chinese American breast cancer survivors who have completed primary treatment will be randomly assigned to either the intervention group or a control group to receive enhanced usual care while waiting for the JLA. Health outcomes are assessed at baseline, immediately post intervention, and 1 and 4 months follow-ups.
Interventions
- Behavioral: Social support intervention
- The social support intervention is a 7-week program includes educational and peer mentoring support components. The education curriculum provides information on recognizing side effects of treatment and differentiating them from symptoms of cancer recurrence, physical therapy and alternative treatment, stress management, recognizing depression and managing emotional problems, communication with family members, and body image. The peer-support component assigns each participant with a mentor who is a breast cancer survivor. They share their own experience with participants and also make weekly phone calls to mentees during the intervention to provide support and address remaining concerns.
Arms, Groups and Cohorts
- No Intervention: Enhanced care and wait-list control group
- Participants in the control group will receive enhanced usual care while waiting for the JLA program. Participants will be given information booklets in Chinese developed by the American Cancer Society and cover common issues related to breast cancer, various treatments, and life after treatment. Participants will be asked to read through the booklet individually.
- Experimental: Social support intervention group
- The intervention is a 7-week program includes educational and peer mentoring support components. The education curriculum provides information on recognizing side effects of treatment and differentiating them from symptoms of cancer recurrence, physical therapy and alternative treatment, stress management, recognizing depression and managing emotional problems, communication with family members, and body image. The peer-support component assigns each participant with a mentor who is a breast cancer survivor. They share their own experience with participants and also make weekly phone calls to mentees during the intervention to provide support and address remaining concerns.
Clinical Trial Outcome Measures
Primary Measures
- Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT)
- Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Secondary Measures
- Change in depressive symptoms as assessed by CES-D
- Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
- Depressive symptoms will be measured with the Chinese short-form version (Boey, 1999) of the Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977) as well as two additional items (“I don’t want to have contact with people, socialize, or go out at all” and “I have thought about hurting myself”) from the Chinese American Depression Scale (CADS-9).
- Change in positive affect as assessed by the PANAS
- Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
- Change in fatigue as assessed by FACIT
- Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
- A short-version (i.e. 6-item) of Functional Assessment of Chronic Illness Therapy-Fatigue scale was used.
- Change in stress as assessed by the Perceived stress scale (PSS)
- Time Frame: Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Participating in This Clinical Trial
Inclusion Criteria
- self-identified to be comfortable speaking Chinese (Mandarin or Cantonese) – having a first breast cancer diagnosis of stages 0-III – having completed primary treatment (surgery, chemotherapy, or radiotherapy) within the last 36 months Exclusion criteria:
- unable to read or speak Chinese (Mandarin or Cantonese) – breast cancer diagnosis of stage IV – live outside of the LA area
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- M.D. Anderson Cancer Center
- Collaborator
- University of California, Los Angeles
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Qian Lu, PhD; MD, Principal Investigator, University of Houston
- Overall Contact(s)
- Qian Lu, PhD; MD, 713-745-8324, qlu@mdanderson.org
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