A multicentre, assessor-blinded, randomized controlled trial to investigate the effectiveness of a blended intervention, focused on personal feedback and coaching regarding physical activity and protein intake, after discharge in patients who have undergone elective gastro-intestinal or lung cancer surgery

Recruiting

• Conditions: lever en galwegen therapeutische verrichtingen & luchtwegen therapeutische verrichtingen; gastro-intestinal cancer surgery; Lungcancer surgery; 10017998

• Registration Number: NL-OMON51948
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 161

Inclusion Criteria

- Scheduled for GI- or lung surgery
- Age >= 18 years
- Surgery with curative intent
- Indication for postoperative hospital stay >= 2 nights
- Able to fill in online questionnaires in Dutch
- Able to give informed consent

Exclusion Criteria

- Wedge excision lung
- Surgery with open/close procedure
- No access to a mobile device compatible for applications
- Mini-Mental State Examination (MMSE) <= 24
- Less than 5 days between inclusion and surgery
- Patients who are wheelchair dependent
- Already participating in a conflicting study (to be determined per
participating centre)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is postoperative recovery in physical functioning<br /><br>measured with the CAT PROMIS-physical functioning item bank. The most important<br /><br>secondary outcome is objectively measured level of physical activity (active<br /><br>minutes per day). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To study the effectiveness of a blended intervention after discharge in<br /><br>patients have undergone elective gastro-intestinal or lung cancer surgery on<br /><br>the following outcome measures:<br /><br>o Physical activity<br /><br>o Protein intake<br /><br>o Lean body mass<br /><br>o Physical performance<br /><br>o Patient specific activity limitations<br /><br>o Pain<br /><br>o Fatigue<br /><br>o Self-efficacy<br /><br>o Quality of life<br /><br>o Global perceived effect<br /><br>o Participation in social roles and activities<br /><br>o CT-determined muscle mass<br /><br>o Postoperative complications<br /><br>o Unplanned hospital readmission within 30 days after discharge<br /><br>o Adverse events</p><br>