Couple-Based Intervention for Patients With Head and Neck Cancer and Their Partners
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
- 否
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
The treatment as usual group will complete all assessements and will not receive the psychosocial couple based intervention.
Couple-Based CBT Intervention
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
Rachel Pulido
Asst Director, Research Compliance
NorthShore University HealthSystem
