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Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years (CanBenefitII)

Published: June 3, 2022

Primary Outcome Measures

  1. 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.
  2. 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.
  3. Secondary outcome data completion rate [ Time Frame: 24 weeks ]
    Assessed by the total number of missing data from the total list of secondary outcomes
  4. Rate of Intervention Completion [ Time Frame: 12 weeks ]
    The percentage of exercises prescribed to the participants compared to the number of those completed.
  5. 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
  6. 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

  1. Free-living daily activity [ Time Frame: Baseline, 24 weeks ]
    Accelerometer; the activpal4 micro units (activpal4;
  2. 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).
  3. Rockwood Frailty Index, a 7-point Clinical Frailty Scale [ Time Frame: baseline, 12 and 24 weeks ]
    1 = very fit, and 7= severely frail.
  4. 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
  5. Grip strength [ Time Frame: baseline, 12 and 24 weeks ]
    Maximum force/tension (kg) in the forearm muscles using a handheld dynamometer.
  6. 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
  7. Weight (kg) [ Time Frame: baseline, 12 and 24 weeks ]
    Tanita body composition monitor and weight scale
  8. 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).
  9. 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.
  10. 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)
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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)
  16. 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)
  17. Treatment toxicity [ Time Frame: baseline, and after 6, 12, and 24 weeks ]
    Cancer treatment-related toxicity (CTCAE v 5)
  18. Height [ Time Frame: baseline, 12 and 24 weeks ]
    measured in cm with a Seneca Stadiometer

Inclusion Criteria

  1. age ≥65 years,
  2. diagnosed with stage III or IV lung cancer or mesothelioma,
  3. starting a new line of systemic anti-cancer treatment,
  4. willing and able to complete study measures and be randomised
  5. able to provide informed written or verbal witnessed consent

Exclusion Criteria

  1. Patients receiving radical chemoradiation therapy (potentially curative and require parental feeding)
  2. Have had more than one dose of new treatment.
  3. Unstable acute condition (e.g., acute infection, severe uncontrolled symptoms) or
  4. Underlying chronic condition (e.g., severe arthritis or dementia) that would impact study compliance.
  5. Unable to provide written or verbal consent.
  6. Insufficient English for consent and study procedures and appropriate interpretation unavailable
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