Back to resultsA Culturally Sensitive Social Support Intervention (JLA)
Primary Purpose
Breast Cancer, Breast Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social support intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Chinese, cancer survivors, Quality of Life, Social Support
Eligibility Criteria
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
Sites / Locations
- Herald Cancer AssociationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Enhanced care and wait-list control group
Social support intervention group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT)
Secondary Outcome Measures
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).
Change in positive affect as assessed by the PANAS
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.
Change in stress as assessed by the Perceived stress scale (PSS)
Full Information
NCT ID
NCT02946697
First Posted
October 25, 2016
Last Updated
July 9, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
University of California, Los Angeles, Herald Cancer Association, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02946697
Brief Title
A Culturally Sensitive Social Support Intervention
Acronym
JLA
Official Title
A Culturally Sensitive Social Support Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
University of California, Los Angeles, Herald Cancer Association, National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms
Keywords
Chinese, cancer survivors, Quality of Life, Social Support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enhanced care and wait-list control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Social support intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social support intervention
Other Intervention Name(s)
JLA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quality of life as assessed by Functional Assessment of Cancer Therapy Scale (FACT)
Time Frame
Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Secondary Outcome Measure Information:
Title
Change in depressive symptoms as assessed by CES-D
Description
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).
Time Frame
Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Title
Change in positive affect as assessed by the PANAS
Time Frame
Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Title
Change in fatigue as assessed by FACIT
Description
A short-version (i.e. 6-item) of Functional Assessment of Chronic Illness Therapy-Fatigue scale was used.
Time Frame
Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Title
Change in stress as assessed by the Perceived stress scale (PSS)
Time Frame
Baseline before intervention and immediately, 1 month, and 4 months after the intervention
Other Pre-specified Outcome Measures:
Title
Change in cortisol slope
Time Frame
Baseline before intervention and immediately
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Lu, PhD; MD
Phone
713-745-8324
Email
qlu@mdanderson.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lenna Dawkins-Moultin, PhD
Phone
713-792-0005
Email
ldawkins@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qian Lu, PhD; MD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herald Cancer Association
City
Los Angeles
State/Province
California
ZIP/Postal Code
91776
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Loh
Phone
626-286-2600
First Name & Middle Initial & Last Name & Degree
Lucy Young
Phone
626-286-2600
Ext
x13
Email
lucy@cchc.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34550088
Citation
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.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
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A Culturally Sensitive Social Support Intervention
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