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Fit 4 Surgery 2: Using an app to get fit for lung cancer surgery

Fit 4 Surgery 2: A randomised controlled trial to investigate an App-based, motivation-theory grounded, personalised, comprehensive, prehabilitation programme in addition to usual care versus usual care alone to enhance recovery of physical function and reduce complications after lung cancer surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40412033
Enrollment
902
Registered
2023-05-04
Start date
2023-10-12
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery from lung cancer surgery Cancer

Interventions

TRIAL INTERVENTION Usual Care vs F4S-2 digital platform (App) and Usual care Usual Care: This may be a range of healthcare services that provide all or one of the following: information for the part

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or over 2. With a suspected clinical or pathological diagnosis of primary lung cancer 3. Selected for elective curative lung resection 4. Able to undergo F4S.2 intervention for minimum 2 weeks prior to surgery 5. Willing and able to provide informed consent 6. Willing to use F4S app 7. Willing to complete study questionnaires

Exclusion criteria

Exclusion criteria: 1. Emergency surgery 2. Patients requiring parenteral nutrition

Design outcomes

Primary

MeasureTime frame
1. Patient-reported quality of physical function scale recovery (using the EORTC-QLQ-C30) at 30 days after surgery 2. Surgical complications (using the Comprehensive Complication Index (CCI)) at 30 days after surgery

Secondary

MeasureTime frame
Current secondary outcome measures as of 24/10/2024: 1. Days Alive and at Home Within 30 days (DAH30) 2. Patient-reported quality of life (using the EORTC-QLQ-C30 & LC 29) at Baseline, Day of Surgery, 30 days, 3 and 6 months after surgery 2.1. EORTC-QLQ-C30 Domains: Global Health Status, Physical Functioning, Role Functioning, Emotional Functioning, Cognitive Functioning, Social Functioning 2.2. EORTC-QLQ-LC29 Domains: Coughing, Shortness of Breath, Side Effects of Treatment, Fear of Progression, Surgery related problems 3. Mental health/well-being (using the Hospital Anxiety and Depression at Scale (HADS)) at Baseline, Day of Surgery, 30 days, 3 and 6 months after surgery 3.1. Domains: Anxiety, Depression 4. Motivational processes at Day of Surgery, 30 days and 3 months after surgery (Intervention only): 4.1. Questionnaires: Behavioural Regulation in Exercise Questionnaire (BREQ), Basic Psychological Need Satisfaction in Exercise Scale (BPNSES), Health Care Climate Questionnaire (HCCQ) 5. Physical status assessed by the incremental shuttle walk test (ISWT) at Baseline and 30 days after surgery; sit-to-stand test and hand grip test at Baseline, Day of Surgery, Day of Discharge and 30 days after surgery. 6. Nutritional assessment including weight (PG-SGA (SF)) at Baseline, Day of Surgery and 30 days after surgery. Health Economic Outcomes 7. Health-related quality of life (EORTC-QLQ-C30, LC-29 and EQ-5D-5L) at Baseline, Day of Surgery, 30 days, 3 and 6 months after surgery 8. Health resource usage at 30 days and 6 months after surgery Previous secondary outcome measures: 1. Days Alive and at Home Within 30 days (DAH30) 2. Patient-reported quality of life (using the EORTC-QLQ-C30 & LC 29) at 14 days, 30 days, 3 and 6 months after surgery 3. Mental health/well-being (using the Hospital Anxiety and Depression Scale (HADS)) at 14 days, 30 days, 3 and 6 months after surgery 4. Symptom score (using a 0-10 point VAS) (intervention only) at baseline. 5. Motivational proces

Countries

England, Scotland, United Kingdom

Contacts

Public ContactLaura Ocansey
l.ocansey@bham.ac.uk+44 121 415 9115

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026