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.
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: massage therapy
Procedure: pain therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study|
- Area-under-the-curve (AUC) pain for the first 24 hours after treatment [ Designated as safety issue: No ]
- Analgesics medication use in chronic pain patients as measured by the Medication Quantification Scale (MQS) every 24 hours [ Designated as safety issue: No ]
- Duration of massage effects, patient gender, referral source, expectancy and associations between changes in levels of arousal and changes in pain scores [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
- 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|