Home-based exercise programme on disease-free survival among early-stage high-risk recurring cancers Other
Conditions
Interventions
This is a multi-centre, phase II randomised controlled feasibility trial in at least 10 hospital sites in Yorkshire and the North of England to compare a personalised, multicomponent exercise programm
Sponsors
University of Hull
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Diagnosed with early-stage high-risk cancer, defined as: 2.1. Non-small cell lung cancer: diagnosed with stages II or IIIA disease 2.2. Breast: Triple-negative breast cancer: diagnosed with = stage II (defined as an Allred score < = 4 and her2 negative), 2.3. Bowel: diagnosed with stage II, T4 disease only or any stage III disease 3. Within 12 weeks of completing primary treatment (e.g., surgery +/- chemo and/or radiation therapy) with curative intent, or for those on adjuvant immunotherapy or tyrosine kinase inhibitors, as soon as they begin this phase of their adjuvant treatment, 4. Willing and able to complete study measures and be randomised, 5. Able to provide informed consent, 6. Willing and able to engage remotely either by phone or video-based communications.
Exclusion criteria
Exclusion criteria: 1. Being treated for low-risk early-stage or incurable cancers, 2. Having an irreversible unstable acute condition (e.g. acute infection, severe uncontrolled symptoms) or underlying chronic condition or disease (e.g. severe arthritis or dementia) that would impact study compliance. 3. Mental capacity impaired to the extent that a course of systemic anti-cancer therapy is considered inappropriate by treating oncologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcome measures: 1. Site set-up measured using the length of time in months from site approach to recruitment opening from data recorded in the study record at the study end 2. Recruitment measured using a traffic light system (=70% target within the time allocated frame: Green; 40-70%: Amber; <40% target within the allocated time frame: Red) based on the recruitment rate reported on the study record (the number of people recruited at 16 months divided by the original sample aim (660)) at 24 months 3. Intervention delivery and adherence measured using the traffic light system (= 80% of participants completed = 75% of personal prescription: Green; 50 – 79% of participants completed = 75% of personal prescription: Amber; <50% of participants completed = 75% of personal prescription: Red) from data recorded in the study records at the end of month 19 (end of tailored intervention delivery) 4. Intervention adherence measured using the number of people completing at least 75% of their personalised exercise prescription from data recorded in the study records at 12 months 5. Data completion measured using the percentage of missing data for questionnaires and physical measures from data recorded in the study records at baseline, 6 months, 12 months, and 24 months 6. Adverse events measured using the number of adverse events and serious adverse events from data in study records at 24 months 7. Adverse events measured using the number of adverse events and serious adverse events at 24 months Primary efficacy aim/objective: To determine the efficacy of moderate-to-vigorous exercise on 2-year disease-free survival for people diagnosed with lung, breast, or bowel cancers that have a higher risk of early recurrence after the completion of primary treatment (surgery +/- chemotherapy and/or radiotherapy) measured after 24 months via case note review/NHS digital record. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical fitness assessed as submaximal VO2 via 6 min walk test at baseline, 6 and 12 months 2. Patient-reported quality of life (cancer-specific) measured via self-reported questionnaires, SQUASH questionnaire, EQ-5D-5L, EQ-VAS, Functional Assessment of Cancer Therapy plus fatigue subscale questionnaires at baseline, 6, 12 and 24 months 3. Variables related to meeting MVE guidelines (e.g., age, performance status, attitudes, self-efficacy, etc.,) via the Australian Karnosfsky Performance Scale (AKPS), short physical performance battery (SSPB), grip strength and body composition (BMI) at baseline, 6 and 12 months. Plus, case notes and self-reported questionnaires, SQUASH questionnaire, EQ-5D-5L, EQ-VAS, Functional Assessment of Cancer Therapy plus fatigue subscale questionnaires at baseline, 6, 12 and 24 months. To explore the use of NHS Digital to support longer-term data collection in a full definitive trial measured at 24 months: 1. Willingness for use of NHS Digital data measured using the number of people consenting to have data linkage at baseline 2. Ability to obtain data on cancer recurrence and survival from NHS Digital up to 5 years after study participation measured using the number of consented participants with completed 5-year collected from NHS Digital at 5 years. | — |
Countries
England, United Kingdom
Contacts
Public ContactCindy Forbes
Outcome results
None listed