Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
|ClinicalTrials.gov Identifier: NCT00494910|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2007
Last Update Posted : August 4, 2017
|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 2018|
|Estimated Study Completion Date :||July 2018|
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 ]
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|