lung cancer Non-small cell lung carcinoma
Conditions
Interventions
Multimodal prehabilitation program, with a duration of approximately 3 weeks,
consisting of:
1. Physical exercise
a) Endurance
b) Strength
2. Nutritional support
a) Optimization of nutritional statu
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - *18 years of age - NSCLC, pathologically confirmed or high clinical suspicion - 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 multidisciplinary team meeting - Written informed consent
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: 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). 2. The effect of the multimodal prehabilitation program on functional capacity, measured at the end-of-program test moment (3-4a few days before surgery), and during follow-up (6 weeks and 3 months after surgery) as compared to baseline and the control group. 1. Feasibility: The multimodal prehabilitation program is considered feasible if at least 80% of participants (n=8 out of 10 in both centers) underwent at least a sufficient program. A sufficient program is defined as a program in which at least 80% of the goals is reached, as presented in Table 3 in the study protocol. The maximum number of appointments that is offered might differ per patient, e.g. if surgery is planned earlier than 3 weeks after the MDT meeting. In that case, feasibility for that patient will be calculated as *80% of the total number per component for that individual patient. For physical exercise, nutritional support and patient optimization the baseline test moment is mandatory to enter the multimodal prehabilitation program, because these interventions are tailored for the individual patient based on the baseline test moment (SRT, 1RM, BIA and MIP). Therefore, the baseline test moment is incorporated in the definition of feasibility. Feasibility per patient who participated in the multimodal prehabilitation group, will be determined after all data on compliance have been collected (number of attended supervised training sessions recorded, copy of patient's handbook (number of LIT and nutritional supplementation intake rec-orded) and accelerometer read-out (LIT)), i.e. during hospital admission for surgery. Feasibility of the multimodal prehabilitation p | — |
Secondary
| Measure | Time frame |
|---|---|
| - Evaluate the complete program and per component, e.a. compliance and satisfaction - Determine cost effectiveness of the prehabilitation program - Determine the effectiveness of the program on nutritional and mental status, smoking cessation, patient optimization and reported Quality of Life (QoL) in comparison with the control group - 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 - 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. | — |
Countries
Netherlands
Outcome results
None listed