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临床试验/NCT01785576
NCT01785576已完成不适用

Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners

NorthShore University HealthSystem2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Quality of Life

研究概览

简要总结

The purpose of this study is to determine whether a brief couple-based supportive intervention effectively assists patients and their partners coping with the challenges of head and neck cancer.

详细描述

This intervention will adapt a well-validated cognitive-behavioral therapeutic approach in a four-session intervention to teach patients and partners specific couple-based cancer-focused support skills. In addition, in order to gather information on outcome variables, couples will complete three assessments during the course of treatment (pre-treatment, following treatment, and six month follow-up). These assessments will include questionnaire measures as well as couple communication whereby couples will participate in two videotaped conversations whereby one partner of the couple discusses a concern and the other member of the couple provides support. We also will implement a "daily diary" assessment whereby day-to-day psychological and physical symptoms experienced by the patient and partner will be assessed and daily effects of the intervention can be analyzed. Patients and partners will participate in the daily diary portion of the study following the post-assessment. They will be emailed an electronic link to a brief questionnaire daily for 7 days. The items in this daily assessment will comprise questions that are part of the general assessment measures such as dyadic coping, spousal support, and relationship satisfaction. The patient will also complete questions about pain and fatigue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
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

  • Recently diagnosed with Head and Neck Cancer receiving chemotherapy and/or radiation therapy
  • No history of cancer within past 3 years (other than basal cell)
  • Living with partner in a committed relationship at least 6 months
  • Patient and partner speak and read English

排除标准

  • Serious cognitive or emotional issues that preclude full participation in study

研究组 & 干预措施

Treatment as Usual

No Intervention

The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.

Couple-Based CBT Intervention

Experimental

Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.

干预措施: Couple-Based CBT Intervention (Behavioral)

结局指标

主要结局

Quality of Life

时间窗: 6 months

次要结局

  • Spousal Support(6 months)

研究者

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

Rachel Pulido

Asst Director, Research Compliance

NorthShore University HealthSystem

研究点 (2)

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