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

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen's University, Belfast

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise

    Other intervention

    Participants will participate in up to twenty, supervised exercise sessions, performed within the radiotherapy department, immediately before each treatment. Each session has a 20 minute duration at one of four exercise intensity levels based on the participants baseline assessment results, and preferences.

  • radiotherapy

    Radiation

    Study participants will have been diagnosed with stage I-III NSCLC and prescribed radiotherapy administered as 55Gy in 20 fractions over 4 weeks or 60Gy in 15 fractions over 3 weeks as their primary treatment as per standard treatment pathways within the trust

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Pre-Radiotherapy exercise armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Eligibility rates

The percentage of eligible participants identified and approached through participant screening

Time frame
Screening and enrolment
2

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
3

Exercise programme attendance

The total number of attended sessions by the total number provided

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

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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

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

Other outcomes

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