Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Screening Questionnaires:
Signing this consent form does not mean that you will be able to take part in this study. You will complete some questions about your mood to help researchers decide if you are eligible to take part in this study. It will take 10 to 15 minutes to complete these questions.
The researcher will discuss the questionnaire results with you and provide you with a list of community referrals and resources.
If your responses to the questions show that you are distressed, you will be eligible to take part in this study. If your responses to the questions show that you are not distressed, you will be randomly selected (as in the flip of a coin) to take part in this study.
If your responses to the questions show that you may harm yourself, a licensed psychologist will follow-up with you and make recommendations for future treatment.
Study Questionnaires:
If you are found to be eligible and are selected to take part in this study, you will be asked to complete questionnaires that will have questions about your medical history, quality of life, mood, thought processes, methods of coping with the disease, and support that you receive from others. It will take about 1 hour to complete these questionnaires.
Support Groups:
You will also take part in a support group program for either prostate or breast cancer patients. Each support group will be made up of about 10 members. Each group will meet 1 time each week for 10 weeks. Each meeting will last about 2 hours. At each meeting, patients will discuss and learn about methods of coping with the disease and ways to relax.
All meetings will be audio-recorded. Recordings will be reviewed by the research team to make sure that the groups are covering the program content.
Length of Study:
You will be on study for about 3 months.
End-of Study Questionnaires:
After the last support group meeting, you will complete questionnaires that will ask questions about your medical history, quality of life, mood, thought processes, methods of coping with the disease, and support that you receive from others. You will be off study after you have completed the end-of-study questionnaires.
This is an investigational study.
Up to 240 patients will take part in this study. Up to 204 will be enrolled at MD Anderson.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of prostate or breast cancer, regardless of treatment
- No evidence of metastatic disease
- Able to read, speak, and write English
- Resides within one hour of M.D. Anderson Cancer Center
- 21 years of age or older
- Able to provide meaningful informed consent as judged by a research team member
- Being a distressed patient: a T score greater than or equal to 63 on the Global Severity Index (GSI) of the Brief Symptom Inventory (BSI) or a T score greater than or equal to 63 on any two primary dimensions of this measure, or being a non-distressed patient: a T score of < 63 on the GSI and a T score of <63 on all primary dimensions of the BSI.
Exclusion Criteria:
1) None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Homogeneous Support Group
|
10 weekly group meetings lasting 2 hours.
Surveys
|
|
Heterogeneous Support Group One
|
10 weekly group meetings lasting 2 hours.
Surveys
|
|
Heterogeneous Support Group Two
|
10 weekly group meetings lasting 2 hours.
Surveys
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient Psychological Functioning and Quality of Life (QOL)
Time Frame: Baseline and Month 3: Questionnaires & Support Group Assessments
|
Baseline and Month 3: Questionnaires & Support Group Assessments
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To study if the characteristics of the members of the support group program can have an effect on the quality of life of other members of the support group program.
Time Frame: 2 Years
|
2 Years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cindy L Carmack Taylor, PHD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-0594
- 1R21CA126854 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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