Massage Therapy in Treating Patients With Cancer Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of cancer
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Baseline pain score ≥ 2 on a 0-10 rating scale where 0 = no pain
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Pain syndrome must be the result of cancer and/or cancer treatment
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No postoperative or other acute procedural pain
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Concurrent pharmacologic pain therapy allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Barrie R. Cassileth, PhD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 03-046