Multimodal prehabilitation in NSCLC patients undergoing surgery
- Conditions
- on-small cell lung cancer
- Registration Number
- NL-OMON21254
- Lead Sponsor
- MMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- =18 years of age
- NSCLC, pathologically confirmed or high suspicion of NSCLC, with an indication for anatomical lung resection
- Eligible for anatomical lung resection, that will be performed in MMC or ASz
- Straight forward preoperative work-up, with confirmation of eligibility for surgery by lung surgeon before the MDT meeting
- Written informed consent
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Inability to give written informed consent (illiteracy, language barrier, cognitive disabilities)
- Contra-indication for training (e.g. comorbid conditions, signs of undiagnosed cardiac disease, physical or psychological impairments)
- Renal insufficiency, defined as estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m2 (estimated using the Modification of Diet in Renal Disease (MDRD) formula in the MMC and estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula in the ASz)
- Participation in MEDIAST trial (NTR6528; NL60692.015.17)
- In case of patients in ASz: referral by pulmonologist from Beatrix hospital, Gorinchem (the Netherlands) for surgery in ASz
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes: <br>1.Feasibility of the multimodal prehabilitation program (without extending the time from MDT meeting to surgery beyond the DLCA-S norm of 3 weeks); defined as: =80% of participants completed a sufficient multimodal prehabilitation program (sufficient program defined as: =80% of goals reached).<br>2.The effect of the multimodal prehabilitation program on functional capacity, measured with the 6-minute walk test, steep ramp test and 1-repetition maximum at the end-of-program test moment (3-4 days before surgery), and during follow-up (6 weeks and 3 months after surgery) as compared to baseline and as compared to control subjects who did not participate in the multimodal prehabilitation program.
- Secondary Outcome Measures
Name Time Method Secondary Objectives <br>To:<br>-Evaluate the complete program and per component, e.a. compliance and satisfaction;<br>-Determine cost effectiveness of the prehabilitation program;<br>-Determine the effectiveness of the program on nutritional and mental status, smoking cessation, patient optimization and reported Quality of Life (QoL) as compared to baseline and to the control group;<br>-Determine the effect on clinical outcome (mortality, length of stay, complication rate and re-admission rate) compared to control group and historical cohort as reported in DLCA-S 2018;<br>-Study the correlation between maximal oxygen uptake reported through the physical condition questionnaire and as determined with the steep ramp test and if applicable, cardiopulmonary exercise test.