REST: Reducing End-of-Life Symptoms With Touch - Full Text View

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 II

MedlinePlus related topics:

Cancer Hospice Care Palliative Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Efficacy of Massage at the End of Life

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
	University of Colorado Cancer Center
	Denver, Colorado, United States, 80262
	Hospice of St. John
	Lakewood, Colorado, United States, 80215
	Pike's Peak Hospice and Palliative Care
	Colorado Springs, Colorado, United States, 80903
	Pathways at Hospice of Metro Denver
	Denver, Colorado, United States, 80246

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 at Denver and Health Sciences Center

Principal Investigator:	Marlaine Smith, RN, PhD	University of Colorado at Denver and Health Sciences Center

More Information

Click here for the Population-Based Palliative Care Research Network Web site This link exits the ClinicalTrials.gov site

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Massage

Palliative Care

Hospices

Cancer

Study placed in the following topic categories:

Pain

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00065195