REST: Reducing End-of-Life Symptoms With Touch

NCT ID: NCT00065195

Last Updated: 2008-01-25

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

PHASE2

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to determine whether massage therapy is effective in reducing pain and distress and improving quality of life among cancer patients at life's end.

Detailed Description

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Relieving physical and emotional symptoms is a key component of end-of-life care. Despite care, terminally ill patients are still significantly burdened by unrelieved symptoms. Therapies that have potential to alleviate these symptoms deserve thorough investigation.

This study will last 3 weeks. Participants in this study will be randomly assigned to receive six sessions of either moving or nonmoving touch therapy, in addition to usual hospice care, for 2 weeks. Moving touch therapy consists of massage therapy in which a trained therapist continually touches a person's body. The nonmoving touch therapy will be conducted by volunteers who have no previous experience in massage. Participants in this group will have a volunteer rub specific body parts for 3-minute intervals. Because current evidence suggests that thoughts of healing may influence the effectiveness of touch therapy, volunteers in the nonmoving therapy group will distract their minds to avoid thinking of healing processes. In both groups, the person administering the touch therapy will note all interruptions during a session, including talk, music, and television. Interviews about medication use, pain, and quality of life will be used to assess participants; these interviews will be conducted at study start, immediately before and after each therapy session, and at Weeks 1, 2, and 3.

Conditions

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Neoplasms Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Moving touch therapy

Intervention Type PROCEDURE

Nonmoving touch therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Advanced cancer, with at least moderate pain 1 week prior to study entry
* Life expectancy of at least 3 weeks
* Able to speak English

Exclusion Criteria

* Massage therapy within 1 month prior to study entry
* Current use of anticoagulants
* Platelet count less than 10,000
* Unstable spine that would interfere with touch therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Jean S. Kutner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Marlaine Smith, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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San Diego Hospice

San Diego, California, United States

Site Status

Pike's Peak Hospice and Palliative Care

Colorado Springs, Colorado, United States

Site Status

Pathways at Hospice of Metro Denver

Denver, Colorado, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

Hospice of St. John

Lakewood, Colorado, United States

Site Status

Hope Hospice and Palliative Care

Fort Myers, Florida, United States

Site Status

LifePath Hospice and Palliative Care, Inc.

Tampa, Florida, United States

Site Status

Hospice Care in the Berkshires, Inc.

Pittsfield, Massachusetts, United States

Site Status

Hospice at Charlotte

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R01AT001006-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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