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临床试验/NCT00900835
NCT00900835已完成不适用

Reducing Barriers to Pain and Fatigue Management

City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2005年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
470
试验地点
2
主要终点
Quality of life

研究概览

简要总结

RATIONALE: Collecting information over time about patients' and health care providers' understanding of pain and fatigue and providing education about pain and fatigue management may improve quality of life.

PURPOSE: This clinical trial is studying pain and fatigue management in patients with breast cancer, prostate cancer, colon cancer, or lung cancer.

详细描述

OBJECTIVES:

  • To test the effects of the Passport to Comfort (Passport) intervention at 1 and 3 months post-intervention by comparing baseline data to the high-intensity intervention.
  • To test the effects of select demographic and disease/treatment variables on outcomes of the Passport model at 1 and 3 months post-intervention compared to pre-intervention.
  • To examine perceived patient and professional satisfaction with the Passport model.
  • To test the effects of the Passport intervention by comparing high-intensity to low-intensity.

OUTLINE: Patients are stratified according to cancer diagnosis (breast vs prostate vs colon vs lung), pain level (< 4 vs ≥ 4 on pain scale), and fatigue level (< 4 vs ≥ 4 on fatigue scale). Patients are assigned to 1 of 3 groups.

  • Group 1 (enrolled during months 1-8): Patients undergo pain and fatigue assessment periodically by demographic and treatment data, Quality of life-Patient Tool, BQII, Piper Fatigue Scale, Pain and Fatigue Knowledge Tools, and Patient Satisfaction Tool. Patients receive usual care and undergo pain and fatigue evaluation with no algorithms or formal education. Research nurses conduct chart audits to identify professional and system barriers but receive no medical education, peer review, or feedback. Medical professionals undergo assessment periodically by a Demographic Data Tool, Pain and Fatigue Knowledge Tools, Chart Audit Tool, and Provider Satisfaction.
  • Group 2 (enrolled during months 9-30): Patients and medical professionals are assessed periodically as in group 1. Patients undergo a high-intensity Passport intervention with algorithms based on National Comprehensive Cancer Network (NCCN) guidelines, pain and fatigue education once weekly for 4 weeks, and follow-up reinforcement phone calls every 2 weeks. Research nurses conduct chart audits of congruence between practice and guidelines, tape education sessions, and receive feedback from the principal investigator in the form of a Tape-Monitoring Checklist. Medical oncologists attend training on the use of the algorithms, peer review pain and fatigue management audit with feedback, and reinforce and apply content in clinical rounds.
  • Group 3 (enrolled during months 34-57): Patients and medical professionals are assessed periodically as in group 1. Patients undergo a low-intensity Passport intervention as in group 2. Medical professionals conduct realistic implementation of the intervention into existing systems and procedures within the cancer center, less direct education and system intervention, and share group 2 experiences.

After completion of study intervention, patients are followed at 1 and 3 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

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:
  • Diagnosis of breast, prostate, colon, or lung cancer (any stage)
  • Diagnosed ≥ 1 month before study entry
  • Reports pain and/or fatigue intensity ≥ 4 on a scale of 0-10
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • Life expectancy ≥ 6 months
  • Able to read and understand English
  • PRIOR CONCURRENT THERAPY:
  • Not specified

排除标准

  • 未提供

结局指标

主要结局

Quality of life

Pain knowledge of patients and professionals

Fatigue knowledge of patients and professionals

Adherence to algorithm by patients, professionals, and system

Satisfaction of patients and professionals

次要结局

未报告次要终点

研究者

发起方
City of Hope Medical Center
申办方类型
Other

研究点 (2)

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