Addressing the Hidden Patient - A Randomised-controlled Trial of a Tailored Group Intervention for Caregivers of Cancer Patients (PREPARE)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Distress
研究概览
简要总结
Background and study aims: Being a caregiver for someone with cancer can be very difficult emotionally. For many the patient is a family member or friend, and so this can cause the caregiver a great deal of psychological distress. There are currently very few studies looking into the effectiveness of psychological treatments for distressed caregivers of cancer patients. This study is looking at tailored group therapy program for carers of cancer givers. The aim of this study is to find out whether this program can help to lower levels of distress in cancer caregivers and help them to better cope with caring for someone with the illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Time since initial diagnosis (of patient) not longer than six months previously
- •Significant distress against the background of the cancer disease (QSC-R10C exceeding 16 points)
- •Provision of informed consent
- •Aged 18 or over, either gender
排除标准
- •Inability to give informed consent
- •Insufficient German language knowledge
- •Cognitive impairment impeding handling of questionnaires
- •Severe psychiatric disease (acute psychosis or acute suicidality)
结局指标
主要结局
Distress
时间窗: change from baseline distress at 1 week post treatment
measured using the Questionnaire on Stress in Caregivers of Cancer Patients Revised version (QSC-R10C)
次要结局
- General distress(change from baseline general distress at 1 week post treatment and at 6 months post treatment)
- Unmet needs(change from baseline unmet needs at 1 week post treatment and at 6 months post treatment)
- Self-efficacy in coping with the cancer disease(change from baseline self-efficacy at 1 week post treatment and at 6 months post treatment)
- Depression(change from baseline depression at 1 week post treatment and at 6 months post treatment)
- Anxiety(change from baseline anxiety at 1 week post treatment and at 6 months post treatment)
- Utilisation of primary healthcare(change from baseline to 1 week post treatment and 6 months post treatment)
- Positive bonding with the group(change from baseline bonding at 1 week post treatment and 6 months post treatment)