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

Queen's University, Belfast30 enrolled

Overview

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.

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. 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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Eligibility rates

The percentage of eligible participants identified and approached through participant screening

Time frame: Screening and enrolment

Recruitment rate

The total number of potential participants who were approached and agreed to participate as a percentage of the total number who were approached

Time frame: Screening and recruitment

Exercise programme attendance

The total number of attended sessions by the total number provided

Time frame: Weeks 4-8 (PReFACe exercise programme)

Adherence to the 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)

Time frame: Weeks 4-8 (PReFACe exercise programme)

Participant retention rates

The number of participants available to provide outcomes at the post-intervention assessment as a percentage of the total number recruited.

Time frame: 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

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

Time frame: Week 0 (baseline assessment) to week 8 (PReFACe exercise programme end and post-intervention assessment)

Secondary Outcomes

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)

EORTC QLQ-30 is a reliable and validated, multidimensional quality-of-life questionnaire which is widely used in research for people with lung cancer. The QLQ-C30 is composed of both multi-item scales and single-item measures, including: Five functional scales: * Physical * Role * Emotional * Cognitive * Social Three symptoms' scales: * Fatigue * Nausea and Vomiting * Pain A Global health Status (QoL) Six single items: * Dyspnoea * Insomnia * Appetite loss * Constipation * Diarrhoea * Financial difficulties All scales and single-item measures range in score from 0 to 100. High scale scores represent a higher response level, thus: * High scores for functional sales = high/healthy levels of functioning * High global health status = high QoL * High symptom scale/ single item scores = higher symptom burden

Time frame: 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)

EORTC QLQ-LC13 is a reliable and validated, multidimensional quality-of-life questionnaire which is widely used in research for people with lung cancer. The QLQ-LC13 incorporates one multi-item scale to assess dyspnoea, and a series of single items assessing: * Pain * Coughing * Sore mouth * Dysphagia * Peripheral Neuropathy * Alopecia * Haemoptysis All single-item measures range in score from 0 to 100 with high scale scores representing a higher response level, thus: \- High symptom scale/ single item scores = higher symptom burden

Time frame: Week 0 (baseline assessment) to week 8 (end of study assessment)

Impact of exercise programmes effect on symptom burden: Pain likert Scale

Understanding the impact of the exercise programme on symptom burden on participants experience of pain using a 1-10 likert scale: * Scores 1-3 = Mild Pain * Scores 4-7 = Moderate pain * Scores 8-10 = Severe pain

Time frame: Week 0 (baseline assessment) to week 8 (end of study assessment)

Impact of exercise programmes effect on symptom burden: Fatigue likert Scale

Understanding the impact of the exercise programme on symptom burden on participants experience of fatigue using a 1-10 likert scale: * Scores 1-2 = No fatigue * Scores 3-4 = Minor fatigue * Scores 5-6 = Moderate fatigue * Scores 7-8 = Significant fatigue * Scores 9-10 = Extreme fatigue

Impact of exercise programmes effect on symptom burden: Modified Medical Research Council (MRC) dyspnoea scale

The modified MRC dyspnoea scale is a 5-point (0-4) questionnaire that assesses a patient's breathing difficulty, or dyspnoea, during activity. Higher scores correspond with more breathlessness etc: * grade 0 = breathless with strenuous exercise * grade 1 = short of breath when hurrying on level ground or walking up a slight hill * grade 2 = on level ground, I walk slower than people of my age because of breathlessness * grade 3 = I stop for breath after walking about 100 yards or after a few minutes on level ground * grade 4 = Too breathless to leave the house or I am breathless when dressing/undressing

Time frame: 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

Conduct of post-intervention, semi-structured, qualitative interviews with the following groups: 1. Phase 1 participants (who have completed the programme or withdrew from the programme) 2. Phase 1 participants nominated person (friend or family) 3. Healt Care Professionals (HCPs) involved/ exposed to the study A total of 15 participants (n=5 from each group) is deemed sufficient to achieve data saturation. Semi-structured interview schedules were pre-constructed for each group. Interview schedules consist of open-ended questions to explore the participants/experience of the exercise programme in their own words. No scales are used as a part of this outcome.

Time frame: 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.

The distress thermometer is a valid, and accurate screening tool used to quickly monitor for patient's distress with advanced cancer. The thermometer uses a 0-10 scale to measure patient distress over the past week with 0 representing no distress and 10 representing extreme distress. The thermometer also features a "Problem List" (covering practical, family, emotional, spiritual, and physical issues) to pinpoint causes of distress for referral

Time frame: 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

A well-documented, validated and standardised sub-maximal fitness test measuring the distance a person can walk on a flat, solid surface in six minutes. Participants walk back and forth along a measured track to measure total distance covered in meters within six minutes. Greater distance covered (meters) indicate greater baseline fitness. Greater post-test distance covered (meters) than baseline scores indicate improvements in basic mobility. Reduced post-test distance covered (meters) than baseline scores indicate reductions in basic mobility.

Time frame: Baseline assessment (week 0) and post-study assessment (week 8)

Change in baseline to post-intervention physical activity: Huffman Exercise Satisfactions Scale

The Huffman Exercise Satisfaction Scale was developed with stakeholders as a novel approach to measure older adults (aged ≥55 years) satisfaction with their physical activity levels. There questionnaire measures two scales: 1. A Physical activity enjoyment scale, consisting of 8 multiple choice questions. Responses are allocated a range from 1 to 7 with higher values indicate higher levels of enjoyment of physical activity 2. Satisfaction measure, consists of 4, multiple choice questions. Responses to the satisfaction items range from 1 to 7, with higher values indicating higher levels of satisfaction with physical activity. Mean scores are taken from each scale to total participants exercise enjoyment and satisfaction.

Time frame: Baseline assessment (week 0) and post-study assessment (week 8)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts