Exercise and Nutritional Rehabilitation in Patients With Cancer, Randomised (1:1) Unblinded Feasibility Trial of a Rehabilitation Programme (Exercise and Nutrition) Versus Waiting List Control, in Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Feasibility of Rehabilitation programme
研究概览
简要总结
In patients with incurable cancer, general deterioration in their ability to walk, exercise and care for themselves is often regarded as an inevitable consequence of this. In 2015, Hospice UK published a report advocating "Rehabilitative Palliative Care".
However there is limited robust evidence on which to base this approach. Reviews of the literature show limited study numbers but do suggest that rehabilitation may be feasible for advanced cancer patients. However key components were not clear and no recommendations could be given.
This trial is designed primarily to test the feasibility of a rehabilitation programme (exercise and nutritional supplementation) in advanced cancer patients. Feasibility will be the primary outcome measure including rates of recruitment and compliance. Secondary outcome measures include impact on physical function, nutritional status, quality of life for patients and their carers. We will also assess the health economic impact by assessing patient health facility use throughout the trial.
40 patients with advanced cancer living in the community will be recruited from two hospice palliative care teams in Edinburgh. These patients will be randomised in to either the treatment arm: the rehabilitation programme plus standard care, or the control arm: standard care alone. The treatment arm will consist of an 8 week rehabilitation programme, supervised at weekly clinics by a physiotherapist and dietician.
To minimise contamination the control group will be offered the treatment at the end of the 8 weeks (waiting list control).
Measurements will be made for both groups and compared at baseline (week 0), midpoint (week 5) and endpoint (week 9). Recommendations for a larger UK wide trial will be made from the findings of this study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of advanced cancer (defined as metastatic or locally advanced cancer not amenable to curative treatment).
- •Karnofsky score ≥ 60
- •Prognosis greater than 3 months
- •Able to complete trial based assessments
- •Under care of community services at Marie Curie or St Columba's Hospices
- •Ability to comply with trial protocol
- •Ability to provide and have capacity to consent
- •Agree to attend trial centre for trial related activity (St Columba's Hospice)
排除标准
- •Undergoing anti-cancer therapy (hormonal treatment or bisphosphonates permitted)
- •Using enteral nutrition (NG or similar) or parenteral nutrition
- •Co-enrolment in drug trials
- •Inability to swallow
结局指标
主要结局
Feasibility of Rehabilitation programme
时间窗: 8 weeks
Compliance with treatment and trial procedures
次要结局
- Carer quality of life(8 weeks)
- Patient quality of life(8 weeks)
- Sleep quality(8 weeks)
- Change in physical function(8 weeks)
- Nutritional status(8 weeks)
- Contamination in the control group(8 weeks)