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REST: Reducing End-of-Life Symptoms With Touch

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00065195
First received: July 18, 2003
Last updated: January 23, 2008
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Neoplasms
Pain
 Procedure: Moving touch therapy
Procedure: Nonmoving touch therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Efficacy of Massage at the End of Life

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Decreased pain

Secondary Outcome Measures:
  • Less total analgesic medication use.
  • Improved quality of life
  • Decreased physical symptom distress
  • Decreased emotional symptom distress

Estimated Enrollment: 440
Study Start Date: November 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065195

Locations
United States, California
San Diego Hospice
San Diego, California, United States, 92103
United States, Colorado
Pike's Peak Hospice and Palliative Care
Colorado Springs, Colorado, United States, 80903
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
Pathways at Hospice of Metro Denver
Denver, Colorado, United States, 80246
Hospice of St. John
Lakewood, Colorado, United States, 80215
United States, Florida
Hope Hospice and Palliative Care
Fort Myers, Florida, United States, 33908
LifePath Hospice and Palliative Care, Inc.
Tampa, Florida, United States, 33609
United States, Massachusetts
Hospice Care in the Berkshires, Inc.
Pittsfield, Massachusetts, United States, 01201
United States, North Carolina
Hospice at Charlotte
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Jean S. Kutner, MD University of Colorado, Denver
Principal Investigator: Marlaine Smith, RN, PhD University of Colorado, Denver
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00065195     History of Changes
Other Study ID Numbers: R01 AT001006 01-A2
Study First Received: July 18, 2003
Last Updated: January 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Massage
Palliative Care
Hospices
Cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013