A Culturally Sensitive Social Support Intervention (JLA)

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasms
• Intervention / Treatment: Behavioral: Social support intervention

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 Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Lu, PhD; MD; Phone Number: 713-745-8324; Email: qlu@mdanderson.org
• Study Contact Backup: Name: Lenna Dawkins-Moultin, PhD; Phone Number: 713-792-0005; Email: ldawkins@mdanderson.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 91776
      • Recruiting
      • Herald Cancer Association
      • Contact: Alice Loh; Phone Number: 626-286-2600
      • Contact: Lucy Young; Phone Number: x13 626-286-2600; Email: lucy@cchc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: JLA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Change in cortisol slope	Baseline before intervention and immediately

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); University of California, Los Angeles; Herald Cancer Association
• Investigators: Principal Investigator: Qian Lu, PhD; MD, University of Houston

Publications and helpful links

General Publications

• Lu Q, Warmoth K, Chen L, Wu CS, Chu Q, Li Y, Gallagher MW, Stanton AL, Kagawa Singer M, Young L, Loh A. A Culturally Sensitive Social Support Intervention for Chinese American Breast Cancer Survivors (Joy Luck Academy): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Sep 22;10(9):e30950. doi: 10.2196/30950.

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimated): October 27, 2016

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Chinese; Social Support; cancer survivors
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PA18-0280; R01CA180896 (U.S. NIH Grant/Contract); 16402-02 (Other Identifier: University of Houston)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO