Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 6
- 主要终点
- Change in Impact of Event Scale (IES)
研究概览
简要总结
This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care
详细描述
The intervention intends to improving the patient and partners well-being, quality of life and their relationship adjustment.
The couples in the intervention group participates i six to eight couple sessions. The sessions is conducted by an experienced psychologist and takes place one to five months after the patients cancer diagnosis. The control group receives usual care.
The framework of the intervention is attachment theory and the psychologists support and advise the couples in talking candidly about their feelings regarding their new life situation with cancer. The psychologist focus on the couples ability to feel comfortable and safe in each others presence.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women newly diagnosed with a primary breast cancer (in the last 4 weeks)
- •Women cohabiting with a male partner in a romantic relationship
- •Patient and partner speaks and reads danish
排除标准
- •Patients having a previous cancer diagnosis
- •Neoadjuvant therapy for breast cancer
- •Previous hospital admission with diagnosed psychotic episodes
结局指标
主要结局
Change in Impact of Event Scale (IES)
时间窗: Baseline, 2 weeks post-intervention, 10 months follow-up
IES assesses traumatic reactions to the breast cancer diagnosis. Assessed by both patients and partners
Change in The Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline, 2 weeks post-intervention, 10 months follow-up
Assesses feelings of anxiety and depressive symptoms. Assessed by both patients and partners.
Change in The Profile of Mood States - Short Form (POMS-SF)
时间窗: Baseline, 2 weeks post-intervention, 10 months follow-up
Assesses mood changes. Assessed by both patients and partners
次要结局
- Change in Dyadic Adjustment Scale - Revised (DAS-R)(Baseline, 2 weeks post-intervention, 10 months follow-up)
- Change in Relationship Questionnaire (RQ)(Baseline, 2 weeks post-intervention, 10 months follow-up)
- Change in Functional Assessment of Cancer Therapy - Breast (FACT-B)(Baseline, 2 weeks post-intervention and 10 months follow-up)
- Change in Functional Assessment of Cancer Therapy - general population (FACT-GP)(Baseline, 2 weeks post-intervention and 10 months follow-up)
- Change in Functional Assessment of Chronic Illness Therapy-Fatigue(Baseline, 2 weeks post-intervention and 10 months follow-up)
- Change in Post Traumatic Growth Inventory(2-weeks post-intervention and 10 months follow-up)
- Change in EuroQol-5 Dimensions (EQ-5D)(Baseline, 2 weeks post-intervention and 10 months follow-up)
研究者
Anne Nicolaisen
MPH, Ph.D. student
University of Southern Denmark