Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis
NCT ID: NCT00798187
Last Updated: 2019-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
240 participants
OBSERVATIONAL
2009-05-31
2019-03-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Homogeneous Support Group
Group Meetings
10 weekly group meetings lasting 2 hours.
Questionnaire
Surveys
Heterogeneous Support Group One
Group Meetings
10 weekly group meetings lasting 2 hours.
Questionnaire
Surveys
Heterogeneous Support Group Two
Group Meetings
10 weekly group meetings lasting 2 hours.
Questionnaire
Surveys
Interventions
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Group Meetings
10 weekly group meetings lasting 2 hours.
Questionnaire
Surveys
Eligibility Criteria
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Inclusion Criteria
2. No evidence of metastatic disease
3. Able to read, speak, and write English
4. Resides within one hour of M.D. Anderson Cancer Center
5. 21 years of age or older
6. Able to provide meaningful informed consent as judged by a research team member
7. 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Cindy L Carmack Taylor, PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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The University of Texas M.D.Anderson Cancer Center
Other Identifiers
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2008-0594
Identifier Type: -
Identifier Source: org_study_id
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