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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00067288
Other study ID # R21AT001031-01
Secondary ID Breitbart
Status Completed
Phase Phase 2
First received August 14, 2003
Last updated August 16, 2006
Start date May 2002
Est. completion date March 2006

Study information

Verified date August 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

We have developed an 8-week Meaning-Centered Group Psychotherapy designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the limitations of their cancer illness. This project's overall aim is to explore the feasibility and efficacy of this new and unique psychotherapy intervention for advanced cancer patients in enhancing psychological and spiritual well-being and quality of life by comparing it with a standard supportive group psychotherapy.


Description:

As per Brief Summary


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- 21 years of age or older;

- English speaking;

- Stage III or IV solid-tumor or Non-Hodgkin's Lymphoma;

- Receiving ambulatory care at Memorial Sloan-Kettering Cancer Center in New York City;

Exclusion Criteria:

- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention;

- Presence of cognitive impairment disorder, such as delirium or dementia that is sufficient, in the investigator's opinion, to preclude meaningful participation and/or informed consent;

- Karnofsky Performance Rating Scale below 50 or physical limitations or illness severity sufficient to preclude participation in outpatient group psychotherapy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


Intervention

Behavioral:
Meaning-Centered Group Psychotherapy

Standard Supportive Group Psychotherapy


Locations

Country Name City State
United States Memorial Sloan-Kettering Institute for Cancer Research New York New York

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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