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Social Support for Breast Cancer Survivors (JLA Trial)
N/A
Waitlist Available
Led By Qian Lu, PhD; MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having a first breast cancer diagnosis of stages 0-III
Be older than 18 years old
Must not have
Breast cancer diagnosis of stage IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline before intervention and immediately, 1 month, and 4 months after the intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate how a program called Joy Luck Academy can help Chinese American breast cancer survivors by providing them with culturally relevant social support.
Who is the study for?
This trial is for Chinese American breast cancer survivors who are comfortable speaking Mandarin or Cantonese, have had a first diagnosis of stages 0-III breast cancer, and completed primary treatment within the last 36 months.
What is being tested?
The study tests a culturally based social support program called Joy Luck Academy (JLA) to see how it affects Chinese American women who've survived breast cancer. It's a randomized controlled trial, meaning participants are randomly assigned to receive JLA or not.
What are the potential side effects?
Since this intervention involves social support rather than medication, traditional physical side effects aren't expected. Emotional discomfort due to sharing experiences could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My first breast cancer diagnosis was at stage 0 to III.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My breast cancer is at stage IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline before intervention and immediately, 1 month, and 4 months after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline before intervention and immediately, 1 month, and 4 months after the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in depressive symptoms as assessed by CES-D
Change in fatigue as assessed by FACIT
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Social support intervention groupExperimental Treatment1 Intervention
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.
Group II: Enhanced care and wait-list control groupActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Social support intervention
2015
N/A
~170
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,377 Total Patients Enrolled
University of California, Los AngelesOTHER
1,569 Previous Clinical Trials
10,314,121 Total Patients Enrolled
Herald Cancer AssociationOTHER
2 Previous Clinical Trials
232 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,412 Total Patients Enrolled
Qian Lu, PhD; MDPrincipal InvestigatorUniversity of Houston