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临床试验/NCT00002668
NCT00002668终止不适用

PATIENT SKILLS FOR CANCER PAIN CONTROL IN PATIENTS WITH METASTATIC BREAST OR PROSTATE CANCER

Eastern Cooperative Oncology Group36 个研究点 分布在 4 个国家目标入组 13 人开始时间: 1996年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
36
主要终点
Change in pain assessed using the Brief Pain Inventory

研究概览

简要总结

RATIONALE: An outpatient educational and behavioral skills training program may help patients with metastatic breast or prostate cancer live longer and more comfortably.

PURPOSE: This randomized clinical trial studies whether an outpatient educational and behavioral skills training program will improve pain control in patients who have metastatic or recurrent breast or prostate cancer.

详细描述

OBJECTIVES:

  • Evaluate the feasibility of implementing an outpatient education and behavioral skills training program for pain control in a multi-institution setting.
  • Evaluate whether patient education and behavioral skills training improve cancer pain control in patients with recurrent or metastatic breast or prostate cancer.
  • Amend the protocol, with the approval of the Division of Cancer Prevention and Control, to a groupwide 3-arm study if analysis demonstrates feasibility and potential efficacy of the patient education and behavioral skills training program.

OUTLINE: This is a randomized study. Patients are stratified according to diagnosis (breast vs prostate cancer), initial "pain worst" score (4-6 vs 7 or higher), and participating institution. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive standard pain management.
  • Arm II: Patients receive educational intervention (booklets, audiotapes, and videotapes) and behavioral skills training (including a schedule of practice relaxation sessions) in addition to standard pain management. Patients receive a follow-up phone call within 48-72 hours of intervention to review pain status.

Patients on both arms undergo pain and psychological assessments on days 1 and 15.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in pain assessed using the Brief Pain Inventory

时间窗: Assessed over 15 days

Change in worst pain from baseline to day 15

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (36)

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