Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients

NCT00494910 | Completed Phase 3

• 1 other identifier: 07-094
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palliative Care

Keywords

Palliative Care; Terminally Ill; Group Therapy; 07-094

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy.

  16 weeks

Study Arms (2)

1

EXPERIMENTAL

Meaning Centered Group Psychotherapy (MCGP)

Behavioral: Meaning Centered Group Psychotherapy

2

ACTIVE COMPARATOR

standardized Supportive Group Psychotherapy

Behavioral: Supportive Group Psychotherapy

Interventions

Meaning Centered Group Psychotherapy BEHAVIORAL

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

1

Supportive Group Psychotherapy BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Fordham University: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: an effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015 Mar 1;33(7):749-54. doi: 10.1200/JCO.2014.57.2198. Epub 2015 Feb 2.

  PMID: 25646186 DERIVED

Related Links

• Memorial Sloan-Kettering Cancer Center

Study Officials

• William Breitbart, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 2, 2007
• Study Start: June 26, 2007
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

US (1)