Feasibility of a Co-designed PRe-radiotherapy Exercise Programme for People With Stage I-III Non-small Cell Lung cAnCEr: A Single-centre, Single Arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Eligibility rates
研究概览
简要总结
The goal of this clinical trial is to understand the feasibility of a co-designed, pre-radiotherapy exercise programme for people with stage I-III non-small cell lung cancer. This involves people with lung cancer engaging in 20 minutes exercises sessions performed within the radiotherapy department and immediately before each treatment at a personalised intensity.
The main questions it aims to answer are:
To understand the acceptability of the exercise programme through monitoring recruitment rates, attendance of the exercise sessions, and adherence to prescribed exercise intensities. Adverse events will also be monitored to understand programme safety.
Follow-up qualitative interviews will be conducted with participants, their family members, and health care professionals (HCP) to further explore the acceptability of the exercise programme.
In total, participants will be invited to perform up to twenty, supervised exercise sessions scheduled immediately before each treatment within the radiotherapy department. Each exercise session will be twenty minutes in duration and will be performed on a stationary exercise bike. Regarding exercise intensity, there are four levels which may be prescribed depending on people's exercise history, baseline exercise experience, and personal preference. Participants may progress or regress exercise intensity levels throughout the programme depending on their adherence and preference.
详细描述
This is a sequential, mixed method feasibility study consisting of two phases:
Phase 1: Quantitative data collection (feasibility outcomes)
Phase 2: Qualitative data collection (semi-structured interviews)
The exercise programme used in this study was co-designed through a series of workshops and meetings involving individuals affected by lung cancer and healthcare professionals.
Eligible participants must be receiving a prescribed radiotherapy dose of either 55 Gy delivered in twenty fractions or 66Gy administered in 15 fractions, adminstered daily over a 3-4 week period. Accordingly, participants will be prescribed either 15 or 20 exercise sessions, performed once daily and scheduled in alignment with their radiotherapy treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients with clinically or histologically confirmed NSCLC stages 1-
- •Planned to receive treatment with curative intention radiation as primary treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •At least 18 years of age.
- •Can understand and communicate in English.
- •Deemed safe to participate in moderate-intensity exercise and for ECG monitored maximal fitness test through the completion of a medical clearance form by their treating physician.
- •Able to provide written and informed consent.
排除标准
- •Unstable or new angina (diagnosed within the previous month).
- •Unstable or acute heart failure, cardiomyopathy, or other uncontrolled cardiac disease (as evidenced by symptomatic fluid retention, excessive breathlessness, rapid weight gain, swollen ankles or pitting oedema) within the previous 3 months.
- •Presence of new or uncontrolled cardiac arrhythmias.
- •Confirmed or suspected spinal cord compression.
- •Uncontrolled diabetes (e.g. medication changed within 1 month, has had episodes of hypoglycaemia during the previous 2 weeks, or hyperglycaemia which does not decrease with exercise during the previous 2 weeks).
- •Is receiving combination treatment with chemotherapy or immunotherapy.
- •Current active secondary malignancy other than non-melanoma skin cancer.
- •Has had orthopaedic surgery within the previous 3 months on weight-bearing bones.
- •Chest pain while undertaking exercise or physical activity.
- •No > Grade 2 peripheral neuropathy.
- •Metastatic disease beyond localised metastatic involvement (e.g. bone or brain).
- •Has discovered any abnormalities shown on the ECG monitored maximal fitness test which warrant early termination or contraindicate physical activity.
- •People with living with a physical disability which would limit their ability to exercise safely on the stationary exercise bike used within this study.
- •People who are non-English speakers.
- •People who are pregnant.
- •Patient participation in other clinical research - As an additional consideration, patients will be excluded if they are currently enrolled in an alternative exercise or physical activity study, as this may impact outcomes in both studies. However, if they have been involved in research prior to this or are currently involved in research in an unrelated area we will not immediately exclude them from trial participation. Instead, the Doctor of Philosophy (PhD) candidate, Chief investigator, and Principal investigator will discuss their involvement to determine safe and appropriate enrolment.
- •Physical disability - it is with regret that we will be limited in our capacity to offer alternative exercises to accommodate people with a physical disability. To elaborate, the Belfast City Hospitals (BCH) main gym is willing to lend a stationary exercise bike to the research team in support of this study. However, due to limitations on equipment availability in the trust, and limited funding/resources to purchase equipment, people who have a physical disability which limits their capacity to exercise safely on the stationary bike will be excluded from this study. In an ideal scenario, we would also have a recumbent stationary bike to support more people with physical disability get involved within this research.
研究组 & 干预措施
Pre-Radiotherapy exercise arm
Participants within the experimental arm will participate in the co-designed, pre-radiotherapy exercise programme alongside treatment.
干预措施: Exercise (Other)
Pre-Radiotherapy exercise arm
Participants within the experimental arm will participate in the co-designed, pre-radiotherapy exercise programme alongside treatment.
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Eligibility rates
时间窗: Screening and enrolment
The percentage of eligible participants identified and approached through participant screening
Exercise programme attendance
时间窗: Weeks 4-8 (PReFACe exercise programme)
The total number of attended sessions by the total number provided
Adherence to the exercise programme
时间窗: Weeks 4-8 (PReFACe exercise programme)
Monitoring the participants ability to complete the advised duration and intensity of exercise during each session (adherence is accepted if completed 75% of duration without intensity modification)
Participant retention rates
时间窗: Week 0 (baseline assessment) to week8 (PReFACe exercise programme end and post-intervention assessment)
The number of participants available to provide outcomes at the post-intervention assessment as a percentage of the total number recruited.
Adverse event Common Terminology Criteria for Adverse Events v5
时间窗: Week 0 (baseline assessment) to week8 (PReFACe exercise programme end and post-intervention assessment)
Assess the tolerability and safety of the intervention, via recording of intervention-associated adverse events. Adverse events will be graded acording to CTCAE v.5 as: * Grade 1 = Mild * Grade 2 = Moderate * Grade 3 = Severe * Grade 4 = Life-threateninig consequences * Grade 5 = Death relate to AE
Recruitment rate
时间窗: Screening and recruitment
The total number of potential participants who were approached and agreed to participate as a percentage of the total number who were approached
Participant retention rates
时间窗: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)
The number of participants available to provide outcomes at the post-intervention assessment as a percentage of the total number recruited.
Adverse event Common Terminology Criteria for Adverse Events (CTCAE) v5
时间窗: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)
Assess the tolerability and safety of the intervention, via recording of intervention-associated adverse events (AE). AEs will be graded according to CTCAE v.5 as: * Grade 1 = Mild * Grade 2 = Moderate * Grade 3 = Severe * Grade 4 = Life-threatening consequences * Grade 5 = Death related to AE
次要结局
- Change from baseline in quality of life using the EORTC QLQ-30(Week 0 (baseline assessment) to week 8 (end of study assessment))
- Change from baseline in quality of life using the EORTC QLQ-LC13(Week 0 (baseline assessment) to week 8 (end of study assessment))
- Impact of exericse programmes effect on symptom burden: Pain likert Scale(Week 0 (baseline assessment) to week 8 (end of study assessment))
- Impact of exericse programmes effect on symptom burden: Fatigue likert Scale(Week 0 (baseline assessment) to week 8 (end of study assessment))
- Impact of exericse programmes effect on symptom burden: Modified Medical Research Council dyspnoea scale(Week 0 (baseline assessment), daily through PReFACe exercise programme (weeks 4-8) and end of study assessment (week 8))
- Baseline compared to post-intervention changes in participant distress levels using the the National Comprehensive Cancer Network (NCCN) Distress thermometer(Baseline assessment (week 0), weekly throughout the PReFACe exercise programme (weeks 4-8) and at post-study assessment (week 8))
- Change in baseline to post-intervention physcial fitness: Six- minute walking test(Baseline assessment (week 0) and post-study assessment (week 8))
- Change in baseline to post-intervention physcial fitness: 30-second sit-to-stand(Baseline assessment (week 0) and post-study assessment (week 8))
- Change in baseline to post-intervention physcial functioning: Rockwood Clinical Frailty Scale(Baseline assessment (week 0) and post-study assessment (week 8))
- Change in baseline to post-intervention physcial activity: The International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Baseline assessment (week 0) and post-study assessment (week 8))
- Change in baseline to post-intervention physcial activity: Huffman Exercise Satisfactions Scale(Baseline assessment (week 0) and post-study assessment (week 8))
- To assess the accessibility, acceptability and experience of the exercise programme through semi-structured qualitative interviews(Weeks 8-14 post-intervention follow-up period)
- Change from baseline in quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-items (EORTC QLQ-30)(Week 0 (baseline assessment) to week 8 (end of study assessment))
- Change from baseline in quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)(Week 0 (baseline assessment) to week 8 (end of study assessment))
- Impact of exercise programmes effect on symptom burden: Pain likert Scale(Week 0 (baseline assessment) to week 8 (end of study assessment))
- Impact of exercise programmes effect on symptom burden: Fatigue likert Scale(Week 0 (baseline assessment) to week 8 (end of study assessment))
- Impact of exercise programmes effect on symptom burden: Modified Medical Research Council (MRC) dyspnoea scale(Week 0 (baseline assessment), daily through PReFACe exercise programme (weeks 4-8) and end of study assessment (week 8))
- Baseline compared to post-intervention changes in participant distress levels using the National Comprehensive Cancer Network (NCCN) Distress thermometer.(Baseline assessment (week 0), weekly throughout the PReFACe exercise programme (weeks 4-8) and at post-study assessment (week 8))
- Change in baseline to post-intervention physical activity: Huffman Exercise Satisfactions Scale(Baseline assessment (week 0) and post-study assessment (week 8))
- Change in baseline to post-intervention physical fitness: Six- minute walking test(Baseline assessment (week 0) and post-study assessment (week 8))
- Change in baseline to post-intervention physical fitness: 30-second sit-to-stand(Baseline assessment (week 0) and post-study assessment (week 8))
- Change in baseline to post-intervention physical functioning: Rockwood Clinical Frailty Scale (CFS)(Baseline assessment (week 0) and post-study assessment (week 8))
- Change in baseline to post-intervention physical activity: The International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Baseline assessment (week 0) and post-study assessment (week 8))
研究者
Gillian Prue
Dr Gillian Prue PhD., HCPC registered, FHEA, MCSP
Queen's University, Belfast