Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study
massage therapy
+ questionaire about pain
+ visit with a volunteer
Supportive Care Study
Summary
Study start date: May 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.92 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location