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临床试验/NCT00632398
NCT00632398已完成2 期

Couples and Cancer: Building Partner Efficacy in Caring

Collinge and Associates, Inc.6 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
228
试验地点
6
主要终点
Acute effects of massage on patient symptoms as assessed by the weekly Study Report card

研究概览

简要总结

RATIONALE: A multimedia education program for family caregivers that teaches simple methods of touch and massage for the comfort of cancer patients at home may be effective in lowering stress, reducing symptoms, and improving quality of life for patients; and may improve caregiver satisfaction and self-efficacy.

PURPOSE: This randomized phase II trial is studying how well multimedia instruction of caregivers in use of touch and massage works for cancer patients and their care partners.

详细描述

OBJECTIVES:

Primary

  • Produce a multimedia program to deliver instructional content in massage for cancer patients and their lay care partners.
  • Determine the effects of the multimedia program on care partner esteem and stress and on the frequency and duration of the care partner's provision of their assigned form of support to the patient.
  • Determine the effects of the multimedia program on patient symptom levels, functional quality of life, perceived stress, and physiologic indices of stress.

Secondary

  • Examine the impact of the multimedia program on care partner concerns about use of touch as a form of support, and on self-efficacy in massage.

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
21 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

Acute effects of massage on patient symptoms as assessed by the weekly Study Report card

Longitudinal effects of massage on patient symptoms as assessed by the weekly Study Report card

Frequency and duration of care partner providing the assigned form of support as assessed by the weekly Study Report card

Care partner esteem as assessed by a 7-item esteem subscale of the Caregiver Reaction Assessment at baseline and then at 12 and 24 weeks

Patient physiological stress measures as assessed by measuring diurnal variation in cortisol and DHEA at baseline and then at 12 and 24 weeks

Patient and care partner perceived stress as assessed by the Perceived Stress Scale at baseline and then at 12 and 24 weeks

Patient functional quality of life as assessed by FACT-G at baseline and then at 12 and 24 weeks

次要结局

  • Care partner self-efficacy and concerns about using touch as support as assessed by an investigator-generated survey at baseline and then at 12 and 24 weeks
  • Care partner utilization of multimedia materials as assessed by the weekly Study Report card

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Collinge, PhD

President

Collinge and Associates, Inc.

研究点 (6)

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