Mind-Body Program for Cancer Patients

Not Applicable

Completed

• Conditions: Neoplasms
• Interventions: Behavioral: Mind-Body Psychotherapy Group

• Registration Number: NCT00179387
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-12-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2016-02-25
• Study Completion: 2016-02-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mind-Body Psychotherapy Group	Psycho-educational / Stress Management group
2	Mind-Body Psychotherapy Group	Spiritual-Existential Support Group

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy	baseline to 2 months and 4 months

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States