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Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fordham University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00494910
First received: June 29, 2007
Last updated: July 24, 2014
Last verified: July 2014

June 29, 2007
July 24, 2014
June 2007
July 2015   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00494910 on ClinicalTrials.gov Archive Site
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 ]
To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy. [ Time Frame: 16 weeks ]
Not Provided
Not Provided
 
Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients
A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Palliative Care
  • 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
  • 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.
  • Experimental: 1
    Meaning Centered Group Psychotherapy (MCGP)
    Intervention: Behavioral: Meaning Centered Group Psychotherapy
  • Active Comparator: 2
    standardized Supportive Group Psychotherapy
    Intervention: Behavioral: Supportive Group Psychotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
253
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00494910
07-094
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Fordham University
Principal Investigator: William Breitbart, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP