JLA: A Culturally Sensitive Social Support Intervention

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02946697
Collaborator
University of California, Los Angeles (Other), Herald Cancer Association (Other), National Cancer Institute (NCI) (NIH)
168
1
2
79
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social support intervention
N/A

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
Anticipated Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
A Culturally Sensitive Social Support Intervention
Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. Change in positive affect as assessed by the PANAS [Baseline before intervention and immediately, 1 month, and 4 months after the intervention]

    3. 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.

    4. 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

    1. Change in cortisol slope [Baseline before intervention and immediately]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herald Cancer Association Los Angeles California United States 91776

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Qian Lu, PhD; MD, University of Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02946697
    Other Study ID Numbers:
    • PA18-0280
    • R01CA180896
    • 16402-02
    First Posted:
    Oct 27, 2016
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 15, 2021