A Culturally Sensitive Social Support Intervention

Not Applicable

Completed

• Conditions: Breast Cancer; Breast Neoplasms
• Interventions: Behavioral: Social support intervention

• Registration Number: NCT02946697
• Lead Sponsor: M.D. Anderson Cancer Center

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Status Verified: 2024-02
• Primary Completion: 2024-10-14
• Study Completion: 2024-10-14
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Social support intervention group	Social support intervention	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in depressive symptoms as assessed by CES-D	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	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 fatigue as assessed by FACIT	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.

Trial Locations

Locations (1)

Herald Cancer Association; 🇺🇸 Los Angeles, California, United States