Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
| Tracking Information | |||||
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| First Received Date ICMJE | June 29, 2007 | ||||
| Last Updated Date | July 23, 2012 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life). [ Time Frame: 16 weeks ] | ||||
| Change History | Complete list of historical versions of study NCT00494910 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy. [ Time Frame: 16 weeks ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients | ||||
| Official Title ICMJE | A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients | ||||
| Brief Summary | The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" group counseling is intended to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" group counseling is intended to help you cope with cancer by giving you a place to express your feelings and get support from other cancer patients. The purpose of this study is to compare the benefits of these two types of counseling approaches for cancer patients. |
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| Detailed Description | To conduct a randomized controlled trial comparing the efficacy of Meaning-Centered Group Psychotherapy (MCGP) versus a standardized Supportive Group Psychotherapy (SGP) in reducing psychological distress (depression and anxiety), end-of-life despair (hopelessness, desire for hastened death, and suicidal ideation), and improving spiritual well-being and overall quality of life in a sample patients with advanced cancer. To assess the relative impact of Meaning-Centered Group Psychotherapy on different aspects of spiritual well-being (e.g., a sense of meaning and purpose versus spirituality linked to religious faith). To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy (e.g., potential mediating and moderating influences such as illness severity, religion and religiosity, level of education, race/ethnicity, level of pre-intervention social support, presence of pain and physical symptom burden). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Palliative Care | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 253 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00494910 | ||||
| Other Study ID Numbers ICMJE | 07-094 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | Fordham University | ||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | July 2012 | ||||
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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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