Understanding the Feasibility of a Co-designed Pre-radiotherapy Exercise Programme - A Single-arm Study

Официальное название

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

Обзор

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 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.

Подробное описание

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 55 Gy delivered in twenty fractions only, administered once daily, five days per week, over a four-week period. Accordingly, participants will be prescribed a total of twenty exercise sessions, performed once daily and scheduled in alignment with their radiotherapy treatment sessions.

Exercise intensity is personalised and based on a submaximal exercise test conducted at the participant's baseline assessment. This test will be used to determine each participant's maximum heart rate, which will then be entered into the Karvonen formula (Karvonen et al., 1957) to calculate percentage heart rate reserve. This calculation will establish individual heart-rate ranges corresponding to light, moderate, and vigorous exercise intensities. Starting exercise intensity level (1-4) will be determined based on a baseline six-minute walking test, clinical frailty score, and participant preference.

The four levels of exercise intensity increase in difficulty, and incorporate various durations of light, moderate, or high intensity exercise, including:

* Level 1: 10-minute warm-up at light intensity continuous cycling followed by 10 minutes of moderate intensity continuous cycling * Level 2: 5-minute warm-up at light intensity continuous cycling followed by 15 minutes of moderate intensity continuous cycling * Level 3: 5-minute warm-up at light intensity continuous cycling, followed by 10 minutes of moderate intensity continuous cycling, and 5 minutes of 30-second-high intensity intervals * Level 4: 5-minute warm-up at light intensity continuous cycling, followed by 5 minutes of 30-second-high intensity intervals, 5 minutes of moderate intensity continuous cycling, and 5 minutes of 30-second-high intensity intervals

All participants will wear a chest-strap heart-rate monitor during each exercise session to ensure they are exercising at the prescribed intensity. Session adherence will be defined as completion of at least 75% of the prescribed exercise duration (i.e. 15-minutes).

Вмешательства

• Другое Exercise
  Participants will participate in twenty, supervised exercise sessions, performed within the radiotherapy department, immediately before treatment. Each session has a 20 minute duration at one of four exercise intensity levels based on the participants baseline assessment results, and preferences.
• Лучевая терапия radiotherapy
  Participants involved in this study will receive 55 Gray (Gy) of radiotherapy only, administered in twenty fractions as per standard treatment pathways within the trust

Первичные конечные точки

• Eligibility rates [Срок оценки: Screening and enrolment]
• Recruitment rate [Срок оценки: Screening and recruitment]
• Exercise programme attendance [Срок оценки: Weeks 4-8 (PReFACe exercise programme)]
• Adherence to the exercise programme [Срок оценки: Weeks 4-8 (PReFACe exercise programme)]
• Participant retention rates [Срок оценки: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)]
• Adverse event Common Terminology Criteria for Adverse Events (CTCAE) v5 [Срок оценки: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)]

Вторичные конечные точки (12)

• 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) [Срок оценки: 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) [Срок оценки: Week 0 (baseline assessment) to week 8 (end of study assessment)]
• Impact of exercise programmes effect on symptom burden: Pain likert Scale [Срок оценки: Week 0 (baseline assessment) to week 8 (end of study assessment)]
• Impact of exercise programmes effect on symptom burden: Fatigue likert Scale [Срок оценки: 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 [Срок оценки: Week 0 (baseline assessment), daily through PReFACe exercise programme (weeks 4-8) and end of study assessment (week 8)]
• To assess the accessibility, acceptability and experience of the exercise programme through semi-structured qualitative interviews [Срок оценки: Weeks 8-14 post-intervention follow-up period]
• Baseline compared to post-intervention changes in participant distress levels using the National Comprehensive Cancer Network (NCCN) Distress thermometer. [Срок оценки: 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 fitness: Six- minute walking test [Срок оценки: Baseline assessment (week 0) and post-study assessment (week 8)]
• Change in baseline to post-intervention physical fitness: 30-second sit-to-stand [Срок оценки: Baseline assessment (week 0) and post-study assessment (week 8)]
• Change in baseline to post-intervention physical functioning: Rockwood Clinical Frailty Scale (CFS) [Срок оценки: 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) [Срок оценки: Baseline assessment (week 0) and post-study assessment (week 8)]
• Change in baseline to post-intervention physical activity: Huffman Exercise Satisfactions Scale [Срок оценки: Baseline assessment (week 0) and post-study assessment (week 8)]

Критерии участия

Критерии включения

• Patients with clinically or histologically confirmed NSCLC stages 1-3.
• Planned to receive treatment with curative intention radiation as primary treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• Northern Ireland Cancer Centre, City Hospital, BHSCT — Belfast

Публикации

• Ziolkowska-Suchanek I. Mimicking Tumor Hypoxia in Non-Small Cell Lung Cancer Employing Three-Dimensional In Vitro Models. Cells. 2021 Jan 12;10(1):141. doi: 10.3390/cells10010141. PMID 33445709
• Seet-Lee C, Yee J, Morahan H, Ross LS, Edwards KM. The effect of aerobic exercise on tumour blood delivery: a systematic review and meta-analysis. Support Care Cancer. 2022 Nov;30(11):8637-8653. doi: 10.1007/s00520-022-07132-0. Epub 2022 Jun 2. PMID 35650456
• Sasso JP, Eves ND, Christensen JF, Koelwyn GJ, Scott J, Jones LW. A framework for prescription in exercise-oncology research. J Cachexia Sarcopenia Muscle. 2015 Jun;6(2):115-24. doi: 10.1002/jcsm.12042. Epub 2015 May 11. PMID 26136187
• World Health Organization (2023) Lung Cancer
• World Health Organization (2018) More active people for a healthier world
• Williams, N. (2017) 'The Borg Rating of Perceived Exertion (RPE) scale ', Occupational Medicine, 67 (5), pp. 404-405.
• Vinod SK, Hau E. Radiotherapy treatment for lung cancer: Current status and future directions. Respirology. 2020 Nov;25 Suppl 2:61-71. doi: 10.1111/resp.13870. Epub 2020 Jun 9. PMID 32516852
• Viamonte SG, Joaquim AV, Alves AJ, Vilela E, Capela A, Ferreira C, Duarte BF, Rato ND, Teixeira MP, Tavares A, Santos M, Ribeiro F. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2023 Dec 1;8(12):1119-1128. doi: 10.1001/jamacardio.2023.3558. PMID 37819656

Идентификаторы

NCT: NCT07554677 · 350051 · 25017GP-SS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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