Integrated Short-term Palliative Rehabilitation to Improve Quality of Life and Equitable Care Access in Incurable Cancer: A Multi-national Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 22
- 主要终点
- Health related quality of life
研究概览
简要总结
The goal of this intervention trial is to determine if palliative rehabilitation in addition to usual care is more effective than usual care at improving health-related quality of life in patients with incurable solid cancer.
详细描述
Background and study aims Cancer is one of the main causes of illness, burden and death in Europe. The Joint Research Centre (JRC) of the EU estimated 2.7 million new cancer cases. For all cancers, between 53-79% of men and 41-62% of women are diagnosed with incurable disease. Their cancer treatment is life-prolonging but will not cure the disease.
Cancer is also a major and growing contributor to disability (loss of function). Recent global estimates suggest a loss of 382 disability-adjusted life years per 1000 individuals. Disability is a poorly recognised and undertreated consequence of incurable cancer. Over time, loss of function results in people not being able to continue with valued roles and routines, to manage usual household and social activities, and to self-care. One-third of adults with cancer require assistance to perform basic activities like washing and dressing, and half need help with extended activities like shopping and transportation. Disability reduces quality of life and well-being. Disability related to daily activity is closely related to unplanned hospital admissions and mortality.
Palliative rehabilitation empowers people with incurable conditions to actively manage their condition themselves, enabling them to live fully and enjoy the best health-related quality of life possible, including cancer towards the end of life. It aims to reduce symptoms and help people to stay independent and socially active. WHO policy on Universal Health Coverage states both rehabilitation and palliative care as essential, quality health services. It recommends they be integrated within and between primary, secondary, and tertiary health systems using a multi-professional workforce. While integrated rehabilitation has been achieved for people with chronic respiratory, cardiac and stroke conditions, this is not the case for people with cancer, especially those living with incurable disease. Access to palliative care services has increased but access to rehabilitation remains varied.
In this study, the investigators are evaluating a rehabilitation intervention that has been designed to meet the needs of people living with advanced cancer. The study is taking place in countries across Europe, and the investigators plan to recruit 340 participants from hospitals. The investigators aim to find out if and how the rehabilitation intervention affects the participants who take part in the study. The investigators will also study how it fits in with current healthcare services.
Who can participate? This study is suitable for patients aged 18 or over, diagnosed with advanced solid cancer: lung, colorectal, breast, prostate or other, irrespective of timing in relation to any oncology or palliative care treatments.
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)
盲法说明
Owing to the nature of the intervention, it is not possible to blind participants or intervention practitioners. Individual participants are allocated on a 1:1 basis to receive either palliative rehabilitation plus usual care or usual care. Treatment allocation will not be disclosed to the CTRU KCTU trial team or to other members of the research teams involved in data analysis to maintain blinding during outcome assessment and to minimise possible bias. Individual participants are allocated on a 1:1 basis to receive either palliative rehabilitation plus usual care or usual care. A computer-generated minimisation programme that incorporates a random element will be used to ensure that treatment groups are well balanced for: trial country ,baseline FACT-G score (<=64, 65-79, 80+), ECOG performance status (2, 3) in order to guard against chance bias in patient allocation for prognostic factors.
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
- •Aged 18 years or older.
- •Diagnosis of incurable solid cancer: lung, colorectal, breast, prostate or other, irrespective of timing in relation to any oncology or palliative care treatments
- •Eastern Cooperative Oncology Group performance status 2-3
- •Able to provide informed consent and complete trial assessments in available languages.
排除标准
- •Blood cancers: Leukaemia, Lymphoma, Myelodysplastic Syndromes (MDS), Myeloproliferative Disorder (MPD), Multiple Myeloma.
- •Currently receiving specialist rehabilitation* for their cancer or co-morbidity-related dysfunction, or received within the two weeks prior to consent.
- •Clinician rated prognosis of less than 3 months.
结局指标
主要结局
Health related quality of life
时间窗: Assessed at 8 weeks after enrollment to the study
Assessed using Functional Assessment of Cancer Therapy (FACT-G) General scale, where high score indicates better functional well-being and quality of life for cancer patients. Lower scores may indicate a greater burden of symptoms, reduced ability to perform daily activities, and overall lower satisfaction with life during the cancer journey.
次要结局
- Disability - World Health Organization Disability Assessment Schedule (WHODAS 2.0)(Assessed at 8 and 16 weeks after enrollment to the study)
- Symptoms - Palliative Outcomes Scale(Assessed at 8 and 16 weeks after enrollment to the study)
- Client Service Receipt Inventory(Assessed at 8 and 16 weeks after enrollment to the study)
- FACT-G: Assessed using Functional Assessment of Cancer Therapy - General(Assessed at 4 and 16 weeks after enrollment to the study)
- Goal attainment- Goal attainment scale (GAS-Light)(Assessed at 8 and 16 weeks after enrollment to the study)