Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2003-05-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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a massage
About 45 minute massage
massage therapy
questionaire about pain
visit with a volunteer
45 minute visit
visit with a volunteer
questionaire about pain
period of quiet time
45 minutes of quiet time
period of quiet time
questionaire about pain
Interventions
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massage therapy
visit with a volunteer
period of quiet time
questionaire about pain
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Barrie R. Cassileth, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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03-046
Identifier Type: -
Identifier Source: org_study_id