NCT02946697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
Last Updated

October 16, 2024

Status Verified

February 1, 2024

Enrollment Period

9.8 years

First QC Date

October 25, 2016

Last Update Submit

October 14, 2024

Conditions

Keywords

Chinesecancer survivorsQuality of LifeSocial Support

Outcome Measures

Primary Outcomes (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 Outcomes (4)

  • Change in depressive symptoms as assessed by CES-D

    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

    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 Outcomes (1)

  • Change in cortisol slope

    Baseline before intervention and immediately

Study Arms (2)

Enhanced care and wait-list control group

NO INTERVENTION

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.

Social support intervention group

EXPERIMENTAL

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

Interventions

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.

Also known as: JLA
Social support intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unable to read or speak Chinese (Mandarin or Cantonese)
  • breast cancer diagnosis of stage IV
  • live outside of the LA area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herald Cancer Association

Los Angeles, California, 91776, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Qian Lu, PhD; MD

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 27, 2016

Study Start

January 1, 2015

Primary Completion

October 14, 2024

Study Completion

October 14, 2024

Last Updated

October 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations