A Culturally Sensitive Social Support Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Culturally Sensitive Social Support Intervention

Conditions
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Breast Cancer, Breast Neoplasms

Intervention / Treatment
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* Behavioral: Social support intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Enhanced care and wait-list control group<br>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<br>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. | Behavioral: Social support intervention<br>* 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.<br>* Other names: JLA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT) |  | Baseline before intervention and immediately, 1 month, and 4 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms as assessed by CES-D | 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). | Baseline before intervention and immediately, 1 month, and 4 months after the intervention | 
| 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 | A short-version (i.e. 6-item) of Functional Assessment of Chronic Illness Therapy-Fatigue scale was used. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese, cancer survivors, Quality of Life, Social Support