Massage Therapy in Treating Patients With Cancer Pain

Phase 2

Completed

• Conditions: Pain; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Other: period of quiet time; Other: massage therapy; Other: visit with a volunteer; Behavioral: questionaire about pain

• Registration Number: NCT00082290
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-05
• Study First Submitted: 2004-05-05
• Study First Submitted QC: 2004-05-05
• Study First Posted: 2004-05-06
• Primary Completion: 2011-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
period of quiet time	period of quiet time	45 minutes of quiet time
visit with a volunteer	questionaire about pain	45 minute visit
a massage	massage therapy	About 45 minute massage
a massage	questionaire about pain	About 45 minute massage
visit with a volunteer	visit with a volunteer	45 minute visit
period of quiet time	questionaire about pain	45 minutes of quiet time

Primary Outcome Measures

Name	Time	Method
reduction in pain	24 hours after treatment	A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States