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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

May 5, 2004
May 6, 2004
December 18, 2015
May 2003
February 2011   (Final data collection date for primary outcome measure)
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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Complete list of historical versions of study NCT00082290 on ClinicalTrials.gov Archive Site
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Massage Therapy in Treating Patients With Cancer Pain
Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Other: massage therapy
  • Other: visit with a volunteer
  • Other: period of quiet time
  • Behavioral: questionaire about pain
  • Experimental: a massage
    About 45 minute massage
    Interventions:
    • Other: massage therapy
    • Behavioral: questionaire about pain
  • Experimental: visit with a volunteer
    45 minute visit
    Interventions:
    • Other: visit with a volunteer
    • Behavioral: questionaire about pain
  • Experimental: period of quiet time
    45 minutes of quiet time
    Interventions:
    • Other: period of quiet time
    • Behavioral: questionaire about pain
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
60
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February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00082290
03-046
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Barrie R. Cassileth, PhD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
December 2015

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