了解共同设计的放疗前锻炼计划的可行性——一项单臂研究 (PReFACe)

实验性的：Pre-Radiotherapy exercise arm

Participants within the experimental arm will participate in the co-designed, pre-radiotherapy exercise programme alongside treatment.

其他：Exercise

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.

辐射：radiotherapy

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

合格率

通过参与者筛选识别并接触的合格参与者百分比

运动项目出勤率

总出席次数占提供总次数的比例

Adherence to the exercise programme

监测参与者在每次训练中完成建议时长和强度的锻炼能力（若能完成75%的时长且未修改强度，则视为依从）

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

Participant retention rates

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

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

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

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

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

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

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.

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

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.

Change in baseline to post-intervention physical fitness: 30-second sit-to-stand

A well-documented, validated, and standardised test to measure functional lower extremity strength. Participants perform as many sit-to-stand reps as they can within 30 seconds.

Change in baseline to post-intervention physical functioning: Rockwood Clinical Frailty Scale (CFS)

The Rockwood CFS is used as a valid assessment tool for screening frailty in older adults. This is a 1-9 scale, with higher scores indicating greater frailty:

1. Very fit
2. Well
3. Managing well
4. Vulnerable
5. Mildly frail
6. Moderately frail
7. Severely frail
8. Very severely frail 9- Terminally ill

Change in baseline to post-intervention physical activity: The International Physical Activity Questionnaire - Short Form (IPAQ-SF)

The IPAQ-SF will be used to explore the influence of the pre-radiotherapy exercise programme on the participant's weekly physical activity levels pre- and post-study. Based on results, physical activity levels based on scores can be calculated as:

1. Inactive
2. Minimally active
3. HEPA active (health enhancing physical activity; a high active category)

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.