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REST: Reducing End-of-Life Symptoms With Touch

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ClinicalTrials.gov Identifier: NCT00065195
Recruitment Status : Completed
First Posted : July 21, 2003
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE July 18, 2003
First Posted Date  ICMJE July 21, 2003
Last Update Posted Date January 25, 2008
Study Start Date  ICMJE November 2003
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Decreased pain
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00065195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Less total analgesic medication use.
  • Improved quality of life
  • Decreased physical symptom distress
  • Decreased emotional symptom distress
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REST: Reducing End-of-Life Symptoms With Touch
Official Title  ICMJE Efficacy of Massage at the End of Life
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Pain
Intervention  ICMJE
  • Procedure: Moving touch therapy
  • Procedure: Nonmoving touch therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
440
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00065195
Other Study ID Numbers  ICMJE R01AT001006-01A2( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean S. Kutner, MD University of Colorado, Denver
Principal Investigator: Marlaine Smith, RN, PhD University of Colorado, Denver
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP