A Culturally Sensitive Social Support Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT)
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
Intervention: Social support intervention (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Change in positive affect as assessed by the PANAS(Baseline before intervention and immediately, 1 month, and 4 months after the intervention)
- Change in fatigue as assessed by FACIT(Baseline before intervention and immediately, 1 month, and 4 months after the intervention)
- Change in stress as assessed by the Perceived stress scale (PSS)(Baseline before intervention and immediately, 1 month, and 4 months after the intervention)
- Change in depressive symptoms as assessed by CES-D(Baseline before intervention and immediately, 1 month, and 4 months after the intervention)