SafeFit Trial: Virtual Clinics to Deliver Universal Interventions to Maintain and Improve Mental and Physical Health in People With Cancer Who Are Following Social Distancing Guidance: A COVID-19 Targeted Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 2
- 主要终点
- Physical Function
研究概览
简要总结
Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universal interventions to maintain and improve physical health, nutritional state and psychological wellbeing in people with cancer who are following social distancing guidance: A COVID-19 targeted trial.
Indication: Male or female participants, aged over 18 years old with suspicion or confirmed diagnosis of cancer (does not require histological confirmation)
Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve physical function as measured by the EORTC-QLQ-C30.
Secondary Objective:
To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve emotional function, quality of life, participant activation (PAM), behaviour change and the effect it has on health economics (EQ-5D-5L).
Exploratory Objective:
Overall Survival and adherence to the intervention/advice using validated tools or development of a web-based toolkit.
详细描述
Rationale: A recent statement by Professor Chris Whitty, Chief Medical Officer, NHS England, emphasised the significant benefits of exercise for all people. He said, "this may be challenging for people self-isolating and even more so for those highly vulnerable people that are having to shield against the virus in their own homes" The coronavirus (COVID-19) pandemic has led to many changes to everyday life including the introduction of social distancing as well as restriction of travel. Treatment plans for patients with cancer are being revised or modified due to risks and benefits of certain treatments in light of the COVID-19 risk. The number of deaths due to the disruption in cancer services is likely to outweigh the number of deaths from coronavirus itself over the next five years.
The effects of this pandemic has reportedly led to increased anxiety and distress and risks deconditioning due to reduced physical activity. The interventions we are proposing aim to enable people with cancer to optimise their physical health, nutritional state and psychological wellbeing and prepare for their treatment pathway (current or modified) and recovery during this uncertain time through exercise, nutrition and psychological support.
The aim is to investigate whether the promotion of these interventions delivered via virtual clinics, in socially distanced people with cancer, can improve physical and psychological function and self-efficacy to self-manage. We are also aiming to evaluate health economics whilst following the COVID-19 government guidelines.
Trial Design: Phase III: Non randomised Interventional Trial
Sample Size: 1100
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Male or female participants, aged over 18 years old
- •Suspicion or confirmed diagnosis of cancer (does not require histological confirmation)
排除标准
- •- Participants unable to give informed consent
结局指标
主要结局
Physical Function
时间窗: Baseline up to 1 year post enrolment
Physical function will be measured using the EORTC-QLQ-C30. Participants will choose from the choices 1 = Not at all; 2 = A little, 3 = Quite a bit, 4 = Very much
次要结局
- Emotional Function(Baseline up to 1 year post enrolment)
- Health related quality of life(Baseline up to 1 year post enrolment)
- Health economics analysis(Baseline up to 1 year post enrolment)
- Patient activation(Baseline up to 1 year post enrolment)
- Nutrition assessment(Baseline up to 1 year post enrolment)
- Distress levels(Baseline up to 1 year post enrolment)
- Functional capacity(Baseline up to 1 year post enrolment)
- The impact of COVID-19 pandemic on psychological functioning(Baseline up to 1 year post enrolment)
- Self-efficacy for self-management of chronic disease(Baseline up to 1 year post enrolment)
- Process Evaluation(Through study completion, an average of 12 months)
- Self-reported physical activity(Baseline up to 1 year post enrolment)