REST: Reducing End-of-Life Symptoms With Touch

Pain Clinical Trial

Official title:

Efficacy of Massage at the End of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065195
• Other study ID #: R01AT001006-01A2
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2003
• Last updated: January 23, 2008
• Start date: November 2003
• Est. completion date: March 2007

Study information

• Verified date: January 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Pain

Intervention

Procedure:
• Moving touch therapy

• Nonmoving touch therapy

Locations

Country	Name	City	State
United States	Hospice at Charlotte	Charlotte	North Carolina
United States	Pike's Peak Hospice and Palliative Care	Colorado Springs	Colorado
United States	Pathways at Hospice of Metro Denver	Denver	Colorado
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Hope Hospice and Palliative Care	Fort Myers	Florida
United States	Hospice of St. John	Lakewood	Colorado
United States	Hospice Care in the Berkshires, Inc.	Pittsfield	Massachusetts
United States	San Diego Hospice	San Diego	California
United States	LifePath Hospice and Palliative Care, Inc.	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased pain
Secondary	Less total analgesic medication use.
Secondary	Improved quality of life
Secondary	Decreased physical symptom distress
Secondary	Decreased emotional symptom distress