Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- reduction in pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
a massage
About 45 minute massage
干预措施: massage therapy (Other)
a massage
About 45 minute massage
干预措施: questionaire about pain (Behavioral)
visit with a volunteer
45 minute visit
干预措施: visit with a volunteer (Other)
visit with a volunteer
45 minute visit
干预措施: questionaire about pain (Behavioral)
period of quiet time
45 minutes of quiet time
干预措施: period of quiet time (Other)
period of quiet time
45 minutes of quiet time
干预措施: questionaire about pain (Behavioral)
结局指标
主要结局
reduction in pain
时间窗: 24 hours after treatment
A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain
次要结局
未报告次要终点