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NCT00179387 Clinical Trial

Mind-Body Program for Cancer Patients

Neoplasms Clinical Trial

Official title:
Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00179387
Other study ID # 2003-412
Secondary ID ACS Research Sch
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2004
Est. completion date February 25, 2016

Study information
Verified date May 2023
Source Albert Einstein College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment.

Description:

Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, relationship strains, existential distress and role losses are all potential "side-effects" of living with cancer and its treatment. Behavioral interventions have shown some success in mitigating distress and QOL impairment among cancer patients. The purpose of this randomized-controlled study is to compare the effects of Mind-body group interventions on the quality of life of patients with advanced cancer. Patients are randomized to one of two psychotherapy groups, which occur weekly for eight weeks. Quality of life assessments are conducted at baseline and two and four-month intervals.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date February 25, 2016
Est. primary completion date February 25, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - On Active Treatment for: Breast Cancer Stage IV, Colorectal Cancer Stage IV, Lung Cancer Stages III & IV, or All Other Cancers (ANY stage on treatment) - Language is English or Spanish Exclusion Criteria: - Patient is currently attending other support/psychotherapy group - Significant Cognitive Impairment - ECOG performance status = 3 or 4 - Current major untreated psychiatric disorder - Unable to attend intervention in following 8 weeks due to medical or practical restrictions

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Mind-Body Psychotherapy Group
Psycho-educational group
• Mind-Body Psychotherapy Group
Spiritual-Existential Group

Locations
Country Name City State
United States Albert Einstein College of Medicine Bronx New York

Sponsors (2)
Lead Sponsor Collaborator
Albert Einstein College of Medicine American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functional Assessment of Cancer Therapy baseline to 2 months and 4 months
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