Massage Therapy in Treating Patients With Cancer Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study

Conditions
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Pain, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: massage therapy
* Other: visit with a volunteer
* Other: period of quiet time
* Behavioral: questionaire about pain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a massage<br>About 45 minute massage | Other: massage therapy<br> <br> Behavioral: questionaire about pain<br> <br> |
| Experimental: visit with a volunteer<br>45 minute visit | Other: visit with a volunteer<br> <br> Behavioral: questionaire about pain<br> <br> |
| Experimental: period of quiet time<br>45 minutes of quiet time | Other: period of quiet time<br> <br> Behavioral: questionaire about pain<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in pain | A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain | 24 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, unspecified adult solid tumor, protocol specific