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临床试验/NCT00244868
NCT00244868已完成3 期

Facilitating Decision Making in Advanced Cancer Patients

Fox Chase Cancer Center6 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2003年7月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
720
试验地点
6
主要终点
Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation

研究概览

简要总结

RATIONALE: A computer-based survey and communication aid may help physicians and patients to communicate better and help make treatment decisions easier.

PURPOSE: This phase III randomized clinical trial is studying how well giving a computer-based survey together with a communication aid works compared to a computer-based survey alone in improving physician-patient communication and treatment decision making in patients with metastatic cancer.

详细描述

OBJECTIVES:

  • Compare satisfaction with physician-patient communication and decisional conflict in patients with metastatic cancer undergoing a computer-based survey with vs without a communication aid.
  • Compare patient expectations regarding potential benefits and adverse reactions associated with treatment options in patients undergoing the computer-based survey and communication aid.
  • Compare the content of physician-patient consultations in patients undergoing the computer-based survey and communication aid.

OUTLINE: This is a randomized, controlled, multicenter study.

Patients are randomized to 1 of 3 study arms.

  • Arm I (generic computer-based survey): Patients complete a 45- to 60-minute generic computer-based survey that assesses demographics, familiarity and comfort with computers, treatment history, and affective elements.
  • Arm II (targeted computer-based survey and communication aid with physician summary report): Patients complete a 45- to 60-minute targeted computer-based survey assessing patient values, information needs, and distress. Patients then complete a targeted computer-based communication aid that addresses cognitive and affective components of cancer treatment education and provides communication skills training. After completion of the survey and communication aid, a summary report of the survey results is generated and provided to the patient's physician.
  • Arm III (targeted computer-based survey and communication aid): Patients complete a targeted computer-based survey and communication aid as in arm II. No summary report is provided to the physician.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DISEASE CHARACTERISTICS:
  • Documented metastatic malignancy
  • First visit with medical oncologist at study site
  • PATIENT CHARACTERISTICS:
  • Performance status
  • Not specified
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Not specified
  • Not specified
  • Able to read and speak English
  • PRIOR CONCURRENT THERAPY: Not specified

排除标准

  • 未提供

结局指标

主要结局

Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation

Assess decisional conflict by Decisional Conflict Scale immediately after the first consultation and at 3 months after study completion

Expectations regarding potential benefits and adverse reactions associated with treatment options by Treatment Options Expectations Scale given immediately after the first consultation and at 3 months after study completion

Assess content of consultation by applying a coding scheme to transcripts and design yes/no questions immediately after the first consultation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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