Mind-Body Program for Cancer Patients

NCT ID: NCT00179387

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-01

Study Completion Date

2016-02-25

Brief Summary

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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

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Psycho-educational / Stress Management group

Group Type ACTIVE_COMPARATOR

Mind-Body Psychotherapy Group

Intervention Type BEHAVIORAL

Psycho-educational group

2

Spiritual-Existential Support Group

Group Type ACTIVE_COMPARATOR

Mind-Body Psychotherapy Group

Intervention Type BEHAVIORAL

Spiritual-Existential Group

Interventions

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Mind-Body Psychotherapy Group

Psycho-educational group

Intervention Type BEHAVIORAL

Mind-Body Psychotherapy Group

Spiritual-Existential Group

Intervention Type BEHAVIORAL

Other Intervention Names

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Stress Management Group Spiritual Support Group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alyson Moadel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

References

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Stein EM, Kolidas E, Moadel A. Do spiritual patients want spiritual interventions?: A qualitative exploration of underserved cancer patients' perspectives on religion and spirituality. Palliat Support Care. 2015 Feb;13(1):19-25. doi: 10.1017/S1478951513000217. Epub 2013 Aug 6.

Reference Type DERIVED
PMID: 23916058 (View on PubMed)

Related Links

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http://www.einstein.yu.edu/cancercenter/support

Support programs for cancer patients \& their families in the Bronx

Other Identifiers

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ACS Research Scholar's Grant

Identifier Type: -

Identifier Source: secondary_id

2003-412

Identifier Type: -

Identifier Source: org_study_id

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