공동 설계된 방사선 전 운동 프로그램의 실행 가능성 이해 - 단일군 연구 (PReFACe)

실험적: Pre-Radiotherapy exercise arm

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

다른: 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.

방사능: 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

적격률

참가자 선별을 통해 식별 및 접근된 적격 참가자의 비율

운동 프로그램 참석

제공된 총 세션 수 중 참석한 총 세션 수

운동 프로그램 준수

각 세션 동안 참가자가 권장된 운동 시간과 강도를 완료할 수 있는 능력 모니터링 (강도 수정 없이 시간의 75%를 완료하면 순응도가 인정됨)

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.