REST: Reducing End-of-Life Symptoms With Touch

January 23, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)

Efficacy of Massage at the End of Life

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

440

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • San Diego Hospice
    • Colorado
      • Colorado Springs, Colorado, United States, 80903
        • Pike's Peak Hospice and Palliative Care
      • Denver, Colorado, United States, 80262
        • University of Colorado Cancer Center
      • Denver, Colorado, United States, 80246
        • Pathways at Hospice of Metro Denver
      • Lakewood, Colorado, United States, 80215
        • Hospice of St. John
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Hope Hospice and Palliative Care
      • Tampa, Florida, United States, 33609
        • LifePath Hospice and Palliative Care, Inc.
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Hospice Care in the Berkshires, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Hospice at Charlotte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Decreased pain

Secondary Outcome Measures

Outcome Measure
Less total analgesic medication use.
Improved quality of life
Decreased physical symptom distress
Decreased emotional symptom distress

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jean S. Kutner, MD, University of Colorado, Denver
  • Principal Investigator: Marlaine Smith, RN, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

July 18, 2003

First Submitted That Met QC Criteria

July 18, 2003

First Posted (Estimate)

July 21, 2003

Study Record Updates

Last Update Posted (Estimate)

January 25, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT001006-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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