Primary Outcome Measures
- Recruitment Rate [ Time Frame: 24 weeks ]
The Recruitment Rate will be assessed by the number of eligible patients approached vs the number of eligible patients consent for the study, providing a number of non-participations. This will be gathered as an aspect of feasibility.
- Retention Rate [ Time Frame: 24 weeks ]
Retention rate will be examined via the number of those who consent to the study compared to the number of those who complete the study.
- Secondary outcome data completion rate [ Time Frame: 24 weeks ]
Assessed by the total number of missing data from the total list of secondary outcomes
- Rate of Intervention Completion [ Time Frame: 12 weeks ]
The percentage of exercises prescribed to the participants compared to the number of those completed.
- Incidence of adverse effects and injuries related to the intervention [ Time Frame: Week 1 to week 12 ]
Assessed by the number and rate of participant recorded adverse effects and injuries related to the intervention
- Incidence of adverse events not related to the intervention [ Time Frame: Week 1 to week 52 ]
The number of adverse events exhibited by the participants will be recorded with an associated grade (where relevant). A example list of adverse events are given below:
- Constipation
- Nausea
- Vomiting
- Diarrhoea
- Skin Rash
Secondary Outcome Measures
- Free-living daily activity [ Time Frame: Baseline, 24 weeks ]
Accelerometer; the activpal4 micro units (activpal4; https://www.palt.com/pals/)
- Australian Karnofsky Performance Scale (AKPS) [ Time Frame: baseline, 12 and 24 weeks ]
Single score from 10 to 100 (a higher score indicates better performance status).
- Rockwood Frailty Index, a 7-point Clinical Frailty Scale [ Time Frame: baseline, 12 and 24 weeks ]
1 = very fit, and 7= severely frail.
- Short Physical Performance Battery (SPBB) [ Time Frame: baseline, 12 and 24 weeks ]
Combines standing balance, 4 metre gait speed, and timed sit-to-stands to assess lower extremity function in older people
- Grip strength [ Time Frame: baseline, 12 and 24 weeks ]
Maximum force/tension (kg) in the forearm muscles using a handheld dynamometer.
- Bioelectrical impedance [ Time Frame: baseline, 12 and 24 weeks ]
Tanita body composition monitor and weight scale, a simple, non-invasive technique for measuring body composition in people with cancer
- Weight (kg) [ Time Frame: baseline, 12 and 24 weeks ]
Tanita body composition monitor and weight scale
- Patient-Generated Subjective Global Assessment (PG-SGA) [ Time Frame: baseline and after 6, 12, and 24 weeks ]
Assessment of nutritional status for people with cancer (scores from 0 – ≥9; 2-3 indicating need for basic nutrition intervention, 4-8 requiring dietetic intervention, and scores ≥9 indicating critical need for symptom management and nutritional intervention).
- Community Healthy Activities Model Program for Seniors (CHAMPS) [ Time Frame: baseline and after 6, 12, and 24 weeks ]
Self-report total physical activity questionnaire designed to estimate weekly frequency of participation and energy expenditure in physical activities.
- Integrated Patient Outcome Scale (IPOS) [ Time Frame: baseline and after 6, 12, and 24 weeks ]
measure of symptom burden with 20 items: one free-text question about main problems and concerns, 17 items on physical, psychological, spiritual problems, communication needs including with family, and practical support, scored on a 5-point Likert-type scale from 0 (best) to 4 (worst)
- Client Service Receipt Inventory [ Time Frame: baseline and after 6, 12, and 24 weeks ]
Validated questionnaire designed to collect information on service utilisation, income, accommodation and other cost-related variables
- EQ-5D-5L [ Time Frame: baseline and after 6, 12, and 24 weeks ]
a generic health-related quality-of-life instrument with a descriptive system that comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which has 5 levels of severity, and in addition, the respiratory bolt on dimension for the EQ-5D-5L
- EQ-VAS [ Time Frame: baseline and after 6, 12, and 24 weeks ]
a self-report measure of overall health using a vertical visual analogue scale, ranging from “worst possible” to “best possible” health
- Days alive and out of hospital [ Time Frame: baseline, and after 6, 12, and 24 weeks ]
Hospital admission (number of days) since starting the programme
- Treatment completion rate [ Time Frame: baseline, and after 6, 12, and 24 weeks ]
Dose of cancer therapy received (percentage of dose received/dose prescribed) Treatment delay (days delayed)
- Infection rate [ Time Frame: baseline, and after 6, 12, and 24 weeks ]
Assessed by the number of episodes requiring antibiotics (oral/IV) Number of episodes requiring hospital admission (number of days)
- Treatment toxicity [ Time Frame: baseline, and after 6, 12, and 24 weeks ]
Cancer treatment-related toxicity (CTCAE v 5)
- Height [ Time Frame: baseline, 12 and 24 weeks ]
measured in cm with a Seneca Stadiometer
Inclusion Criteria
- age ≥65 years,
- diagnosed with stage III or IV lung cancer or mesothelioma,
- starting a new line of systemic anti-cancer treatment,
- willing and able to complete study measures and be randomised
- able to provide informed written or verbal witnessed consent
Exclusion Criteria
- Patients receiving radical chemoradiation therapy (potentially curative and require parental feeding)
- Have had more than one dose of new treatment.
- Unstable acute condition (e.g., acute infection, severe uncontrolled symptoms) or
- Underlying chronic condition (e.g., severe arthritis or dementia) that would impact study compliance.
- Unable to provide written or verbal consent.
- Insufficient English for consent and study procedures and appropriate interpretation unavailable
