Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Success rate of admittance to initial planned oncological treatment
研究概览
简要总结
The study is a randomized study of patients living in four municipalities in Eastern Jutland. After geriatric assessment half of the patients will be offered a tailor-made intervention in their homes. The follow-up will last for at least 90 days and include treatment of the patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The other half of the patients, the results of the assessment and recommendations will be given to the patients and their general practitioner.
The primary efficacy variables are accomplishment of planned cancer treatment, reduction of complications and admissions to hospital and increased quality of life,.
If geriatric assessment and a tailor-made follow-up result in a better quality of life with less complications and admissions the offer may be extended to a longer period, younger age groups and other cancer diagnoses.
详细描述
Cancer of the head and neck (HNC), lung (LC), upper gastrointestinal channel (CUGI) and colo-rectal cancer (CRC) accounts for approximately 40% of cancer incidence in elderly people (defined as ≥70 years) in Denmark (DK). The four cancers account for more than 50% of the annual cancer-related deaths in DK. Incidence and mortality of cancer increases with age. Comorbidity (simultaneous presence of several medical conditions) are more present in older cancer patients than in younger This means that older cancer patients are more vulnerable by physiological, psychological and social means than younger. Older cancer patients frequent develop side effects of cancer treatment than younger cancer patients.
Comprehensive Geriatric Assessment (CGA), is a comprehensive investigation and assessment of various aspects of a person's health, carried out by a multidisciplinary team in order to identify, quantify problems and follow up on the identified problems. CGA comprises collecting information on comorbidity, polypharmacy, physical, psychological and cognitive problems, nutritional status and social support. Problems in these areas implies a worse prognosis in terms of survival, response to treatment and side effects of cancer treatment .
CGA have shown to be able to identify novel health problems in about half of elderly patients with cancer. It has previously been shown that the focused palliative care of patients with lung cancer with a focus on optimization of medication and follow up on unresolved problems increases the quality of life, eases depressive symptoms and increases survival. CGA is shown to be an effective base for intervention in order to increase the survival of the elderly in general (with no known cancer), in order to increase the physical and cognitive status, and to reduce the need for changes in housing facilities. Geriatric intervention based on CGA called Comprehensive Geriatric Care (CGC).
Frailty is a condition that occurs as a result of declining physiological reserve, causing vulnerability to health stressors. One way of defining frailty is based on CGA, where patients are divided into "frail" "vulnerable/pre-frail" and "fit" by performing CGA :
Frail: patients who meet one or more of the following: dependence in Activities of Daily Living (ADL), severe comorbidity, cognitive dysfunction, depression, malnutrition, or more than 7 different fixed daily preparations on time for CGA, (multivitamin not included).
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years or older with cancer of the head and neck, upper gastro intestinal cancer, colo-rectal cancer or Lung cancer, refered to Aarhus University Hospital for evaluation regarding oncological treatment on the Oncology Department at Aarhus University
- •Living in following municipalities: Odder (excl. of the island of Thunø), Faurskov, Skanderborg og Aarhus
- •frail or vulnerable by CGA
- •Signed informed consent. For incapacitated patients: informed consent by relatives
排除标准
- •evaluated 'fit´ by CGA
- •Referred to specialized palliative care at time of first visit at the Oncology department
- •Do not wish to participate
研究组 & 干预措施
Intervention
Geriatric follow up
干预措施: Geriatric Follow up (Other)
Control
Usual care
结局指标
主要结局
Success rate of admittance to initial planned oncological treatment
时间窗: An average of 12 weeks
Oncological specialist evaluates if treatment is completed as planned or if eventual deviations are of minor or major character
Change in Quality of life
时间窗: 90 days
Participants with a Mini-Mental State Examination (MMSE)-score below 25 are tested using "Depression List"
Change in Quality of life (QoL)
时间窗: 90 days
Participants with a Mini-Mental State Examination (MMSE)-score of 25 and above are tested using European Organisation of Research and Treatment of Cancer (EORTC) Core Questionnaire (C30) in combination with Elderly questionnaire (ELD14).
次要结局
- 90-day survival(Within 90 days from first geriatric contact)
- Physical performance, chair-stand-test(Changes in physical performance from first geriatric contact to 90 days after)
- Physical performance, Barthel-100(Changes in physical performance from first geriatric contact to 90 days after)
- Physical performance, FAQ-IADL(Changes in physical performance from first geriatric contact to 90 days after)
- Length of hospital stay(Within 90 days from first geriatric contact)
研究者
Marianne Ørum
MD
Aarhus University Hospital