Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients

Palliative Care Clinical Trial

Official title:

A Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494910
• Other study ID #: 07-094
• Status: Completed
• Phase: Phase 3
• Start date: June 26, 2007
• Est. completion date: March 5, 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: March 5, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Palliative Care

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Fordham University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcomes to be measured include measures of spiritual well-being (meaning) and psychological distress (depression, hopelessness, optimism quality of life).		16 weeks
Secondary	To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy.		16 weeks

External Links

•   Memorial Sloan-Kettering Cancer Center