A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
21 Years
N/A
Both
Palliative Care
Trial Information
A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
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).
Inclusion Criteria:
- > or = to 21 years of age.
- All patients with stage IV solid tumor cancers; or Stage III solid tumor
cancers(excluding breast and prostate cancer) who are receiving ambulatory care at
Memorial Sloan-Kettering Cancer Center.
- Able to communicate with an English speaking therapist
- Able to comprehend English to complete study assessments
Exclusion Criteria:
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to
preclude participation in a group-format intervention (i.e., acute psychiatric
symptoms which require individual treatment).
- Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient, in
the investigator's judgment, to preclude meaningful informed consent and/or data
collection. The Mini Mental State Examination (MMSE) will be used as a cognitive
screening tool. Patients with MMSE scores below 20 will be excluded.
- Karnofsky Performance Rating Scale score below 50 or physical limitations or illness
severity sufficient to preclude participation in outpatient group psychotherapy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life).
Outcome Time Frame:
16 weeks
Safety Issue:
No
Principal Investigator
William Breitbart, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
07-094
NCT ID:
NCT00494910
Start Date:
June 2007
Completion Date:
June 2013
Related Keywords:
- Palliative Care
- Palliative Care
- Terminally Ill
- Group Therapy
- 07-094
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center 1275 York Avenue | New York, New York 10021 |
