Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00494910|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2007
Last Update Posted : August 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Palliative Care||Behavioral: Meaning Centered Group Psychotherapy Behavioral: Supportive Group Psychotherapy||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||253 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Meaning Centered Group Psychotherapy (MCGP)
Behavioral: Meaning Centered Group Psychotherapy
this eight-week (1 ½ hour weekly sessions) Session 1 - Concepts of Meaning and Sources of Meaning Session 2 - Cancer and Meaning Session 3 - Meaning and Historical Context of Life Session 4 - Storytelling, Legacy Project (optional) Session 5 - Limitations and Finiteness of Life Session 6 - Responsibility, Creativity, Deeds Session 7 - Experience, Nature, Art, Humor Session 8 - Transitions, Goodbyes, Hopes for the Future
Active Comparator: 2
standardized Supportive Group Psychotherapy
Behavioral: Supportive Group Psychotherapy
The eight weekly 1 ½ hour sessions will focus on group discussion on a set of specific themes that emerge for patients coping with cancer. The session themes or topics will include such issues as: the discussion of strategies for coping with medical issues and procedures, communication with health care providers and issues related to family, friends, and occupational life.
- 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 ]
- To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy. [ Time Frame: 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494910
|United States, New York|
|Memorial Sloan-Kettering Cancer Center 1275 York Avenue|
|New York, New York, United States, 10021|
|Principal Investigator:||William Breitbart, MD||Memorial Sloan Kettering Cancer Center|