Family and Coping Oriented Palliative Homecare Nursing as a Supplement to Standard Homecare Nursing Aimed at Advanced Cancer Patients - a Randomized Intervention Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 6
- 主要终点
- Patient reported health related quality of life
研究概览
简要总结
When facing life threatening illness such as advanced cancer palliative care is needed to improve quality of life of patients and their families through the prevention and relief of suffering. Palliative care at an early stage prevents the development of problems and symptoms, but time, resources and experience are needed in the primary care sector in Denmark to deal with the problems families experiencing life with advanced cancer are facing. The aims of this study are to test, evaluate and further develop interventions that can help identify and assess problems, resources and opportunities of families experiencing life with advanced cancer, and on this background to help the families cope with their situation in cooperation with healthcare professionals to an extent where the family's quality of life increases, their physical and psychosocial problems are relieved, their symptoms of anxiety and depression are reduced, family satisfaction with health professionals are increased and acute readmissions to hospital are prevented.
详细描述
Screening for patients will take place in the oncological, gynecological medical, surgical departments of three hospitals in Copenhagen, Denmark among patients diagnosed with cancer. Patients eligible for the study will be informed about the study during hospital admission and asked to participate together with a close relative/family member. When written informed consent has been obtained from both patient and relative they will be asked to fill in questionnaires with background information about sociodemographic data, their physical and psychosocial functioning and quality of life EORTC (QLQ-C30/patient and SF36/relative), their symptoms of anxiety and depression (HAD Scale/patient and relative) and family satisfaction with health care professionals(FamCare/relative). When patients have been discharge from hospital to their own home the families are randomized to control or intervention group. First visit from the research nurse takes place no later than one week after randomization. Visits takes place week 1,4,7,10,13 and 16 after randomization. The questionnaires EORTC QLQ-C30 (patient), HAD Scale (patient and relative), SF 36 (relative) and FamCare (relative) are mailed by post to the families to be answered at week 9, 16 and 24 after randomization. Information about the amount of care the family receives from the municipality (standard homecare) will be obtained from municipal registers. Information about readmissions to hospital are obtained from hospital registers.
The research nurses has a minimum of one year experience within specialised palliative care. The nurses has also participated in a two day course on how to produce and utilise family assessment and have been introduced to the background theory on coping and family nursing.
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
- 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
- •At least one of the following
- •Cancer stage 3 or 4 (according to hospital journal)and at least one treatment after relapse without satisfying effect on the disease
- •The patient is aware that further treatment is of palliative or life prolonging nature
- •And also all of following inclusion criterions
- •The patient has a family member that would like to participate (The family member must be involved in the patients care at least two times a week)
- •At least 18 years old (patient and family member)
- •Understand and speak danish (patient and family member)
- •Live in the area of the municipalities of Copenhagen or Frederiksberg
- •Discharge from hospital to own home
- •Written informed consent (patient and family member)
排除标准
- •Terminal fase of disease
- •Contact with specialised palliative care
- •Incapable of co-operating with trial protocol
- •Participant in another behavioral intervention study
结局指标
主要结局
Patient reported health related quality of life
时间窗: Baseline, week 9, week 16 and week 24
The change in mean scores from baseline to each follow up as measured in the Quality of life questionnaire EORTC QLQ-C30 scale score(Developed by the European Organization for Research and Treatment of Cancer)in relation to the Global health status scale.
次要结局
- Family members symptoms of anxiety and depression(Baseline, week 9, week 16, week 24 and 12 months)
- Family members health related quality of life(Baseline, week 9, week 16, week 24 and 12 months)
- Family satisfaction with the health care services provided to the patient(Baseline, week 9, week 16, week 24 and 12 months)
- Patient reported symptoms and problems(Baseline, week 9, week 16 and week 24)
- Patients symptoms of anxiety and depression(Baseline, week 9, week 16 and week 24)
- Acute readmission to hospital(week 16 and 24)
研究者
Anne Birgitte Hjuler Ammari
Principal investigator
Bispebjerg Hospital