Pain Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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