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)
研究组 & 干预措施
Tailored group intervention
Participants take part in the tailored group intervention which consists of five 90-minute group sessions over eight weeks. The sessions are in the form of structured group talk/discussions following specific themes:
Session 1 - Coping and acceptance: identification of common themes from participants' feedback, provision of information about support services, mindfulness practices
Session 2 - Distress: introduction of the distress model, identification of resources, breathing practices
Session 3 - Handling of stressful situations: individual identification in tandems, discussion of common pitfalls in the group
Session 4 - Self-care: inspection of individual daily routines, group collects positive experiences with "windows" for self-care
Session 5 - Feedback and outlook: stabilisation, retrospective reflection on the group experience and its benefits and, if applicable, potential adverse events
干预措施: Tailored group intervention (PREPARE) (Behavioral)
Treatment as usual
Participants are provided with brief information in a leaflet, about the possibilities for individual counselling including referral to the local outpatient cancer counselling centre providing client-centred counselling and financial social work.
干预措施: Individual treatment as usual (Behavioral)
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
- 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)
- 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)