Massage Therapy in Treating Patients With Cancer Pain
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.
|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|
|Study Design:||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|
- 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
|Study Start Date:||May 2003|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082290
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Barrie R. Cassileth, PhD||Memorial Sloan Kettering Cancer Center|