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REST: Reducing End-of-Life Symptoms With Touch

Primary Purpose

Neoplasms, Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Moving touch therapy
Nonmoving touch therapy
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Massage, Palliative Care, Hospices, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Diego Hospice
  • Pike's Peak Hospice and Palliative Care
  • Pathways at Hospice of Metro Denver
  • University of Colorado Cancer Center
  • Hospice of St. John
  • Hope Hospice and Palliative Care
  • LifePath Hospice and Palliative Care, Inc.
  • Hospice Care in the Berkshires, Inc.
  • Hospice at Charlotte

Outcomes

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

Full Information

First Posted
July 18, 2003
Last Updated
January 23, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00065195
Brief Title
REST: Reducing End-of-Life Symptoms With Touch
Official Title
Efficacy of Massage at the End of Life
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Pain
Keywords
Massage, Palliative Care, Hospices, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
440 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Moving touch therapy
Intervention Type
Procedure
Intervention Name(s)
Nonmoving touch therapy
Primary Outcome Measure Information:
Title
Decreased pain
Secondary Outcome Measure Information:
Title
Less total analgesic medication use.
Title
Improved quality of life
Title
Decreased physical symptom distress
Title
Decreased emotional symptom distress

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean S. Kutner, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marlaine Smith, RN, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego Hospice
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pike's Peak Hospice and Palliative Care
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80903
Country
United States
Facility Name
Pathways at Hospice of Metro Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Hospice of St. John
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Hope Hospice and Palliative Care
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
LifePath Hospice and Palliative Care, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Hospice Care in the Berkshires, Inc.
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Hospice at Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

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REST: Reducing End-of-Life Symptoms With Touch

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