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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 24, 2008 | ||||
| Last Updated Date | July 8, 2009 | ||||
| Start Date ICMJE | May 2009 | ||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To study if a support group program is acceptable for patients with prostate cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00798187 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prostate Cancer Support Programs | ||||
| Official Title ICMJE | Efficacy of Prostate Cancer Support Programs: A Social Comparison Theory Analysis | ||||
| Brief Summary | Primary and Secondary Aims: 1a. To collect feasibility and process evaluation data, including rates of recruitment and retention, group attendance, satisfaction, barriers to participation, and feasibility of randomization.
2b. To estimate the effects on distressed patients of a heterogeneous group program and a homogeneous group program on hypothesized mediators (cognitive processing, coping skills, social support) at 3 months and explore correlations between mediators and distress. 2c. To explore changes in distress in the non-distressed patients participating in the heterogeneous group. We will examine our results in the context of existing data of non-distressed patients participating in the control arm of the randomized trial for PC-SMART (see preliminary studies). 2d. To explore differences in distressed and non-distressed patients on measures of social comparison coping and social comparison orientation and examine changes in these measures following intervention participation. |
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| 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 prostate 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. There will be no cost to you for taking part in this study. The study will pay for parking for study-related visits. Up to 240 patients will take part in this study. All will be enrolled at M. D. Anderson. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case Control, Retrospective | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 240 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1) None |
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| Gender | Male | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00798187 | ||||
| Responsible Party | Cindy Carmack Taylor, PHD/Associate Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2008-0594 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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