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Massage Therapy in Treating Patients With Cancer Pain

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ClinicalTrials.gov Identifier: NCT00082290
Recruitment Status : Completed
First Posted : May 6, 2004
Last Update Posted : December 18, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Massage therapy may help lessen pain caused by cancer.

PURPOSE: This randomized phase II trial is studying how well massage therapy works in treating patients with cancer pain.


Condition or disease Intervention/treatment Phase
Pain Unspecified Adult Solid Tumor, Protocol Specific Other: massage therapy Other: visit with a volunteer Other: period of quiet time Behavioral: questionaire about pain Phase 2

Detailed Description:

OBJECTIVES:

  • Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.
  • Determine the feasibility of a definitive trial.

OUTLINE: This is a randomized, controlled, pilot study. Patients are stratified according to in-patient status (yes vs no) and first baseline pain score ≥ 7 (yes vs no). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (massage therapy): Patients receive a light touch ("Reiki") massage over 45 minutes.
  • Arm II (volunteer visit control): Patients receive a 45-minute visit from a trained volunteer who will be available to sit quietly or talk with the patient to discuss issues of concern, as desired by the patient. Volunteers will not touch the patient except to pat their shoulder or briefly hold their hand.
  • Arm III (quiet time control): Patients receive 45 minutes of quiet time. Pain and mood are assessed at baseline, immediately after treatment, at 6 hours and 24 hours after treatment, and then daily for the next 5 days after treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study
Study Start Date : May 2003
Actual Primary Completion Date : February 2011

Arm Intervention/treatment
Experimental: a massage
About 45 minute massage
Other: massage therapy
Behavioral: questionaire about pain
Experimental: visit with a volunteer
45 minute visit
Other: visit with a volunteer
Behavioral: questionaire about pain
Experimental: period of quiet time
45 minutes of quiet time
Other: period of quiet time
Behavioral: questionaire about pain



Primary Outcome Measures :
  1. reduction in pain [ Time Frame: 24 hours after treatment ]
    A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Baseline pain score ≥ 2 on a 0-10 rating scale where 0 = no pain
  • Pain syndrome must be the result of cancer and/or cancer treatment

    • No postoperative or other acute procedural pain

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Concurrent pharmacologic pain therapy allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082290


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barrie R. Cassileth, PhD Memorial Sloan Kettering Cancer Center

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00082290     History of Changes
Other Study ID Numbers: 03-046
First Posted: May 6, 2004    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
unspecified adult solid tumor, protocol specific
pain