A Culturally Sensitive Social Support Intervention

Breast Cancer Clinical Trial

— JLA  

Official title:

A Culturally Sensitive Social Support Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02946697
• Other study ID #: PA18-0280
• Secondary ID: R01CA18089616402
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Qian Lu, PhD; MD
• Phone: 713-745-8324
• Email: qlu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Herald Cancer Association	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Herald Cancer Association, National Cancer Institute (NCI), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in cortisol slope		Baseline before intervention and immediately
Primary	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	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
Secondary	Change in positive affect as assessed by the PANAS		Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Secondary	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
Secondary	Change in stress as assessed by the Perceived stress scale (PSS)		Baseline before intervention and immediately, 1 month, and 4 months after the intervention

External Links

•   MD Anderson Cancer Center Website