To determine whether the multimodal prehabilitation program (without extending the time from MDT meeting to operation beyond the DLCA-S norm of 3 weeks) for patients with NSCLC undergoing anatomical lung resection in MMC and ASz:1. is feasible 2.…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 program will be evaluated per
center and for the entire study group of patients participating in the
multimodal prehabilitation program after the last patient has completed the
program (at time of surgery). Obviously, feasibility will not be determined in
the control group.
2. Functional capacity:
Improvement of functional capacity after participating in the multimodal
prehabilitation program will be measured at the end-of-program test moment (3-4
days before surgery) and during follow-up at 6 weeks and 3 months after surgery
and will be compared to the baseline test moment and to the control group,
using the following tests: (explained in detail in 8.3.2)
i. Steep ramp test (SRT)
ii. 6 Minute walk test (6MWT)
iii. One repetition maximum (1-RM)
Secondary outcome
- 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.
Background summary
Prehabilitation may improve functional capacity and nutritional status before
surgery, resulting in enhanced recovery after surgery, reduced complication
rates, improved quality of life and patient*s overall outcome. A
prehabilitation program may consist of several interventions and should
preferably be multimodal. Such a multimodal program was shown to be feasible,
safe and able to improve functional capacity in patients with colorectal
cancer. However, postponing surgery in order to undergo prehabilitation, cannot
be recommended. Prehabilitation in patients with non-small cell lung cancer
(NSCLC) undergoing anatomical lung resection has not been investigated before.
These patient may benefit from multimodal prehabilitation, especially since the
surgical resection affects a vital organ. In the Netherlands, the maximum
waiting time between the multidisciplinary team (MDT) meeting and surgery is 3
weeks, according to the Dutch Lung Cancer Audit-Surgery (DLCA-S). Whether it is
feasible to fit a prehabilitation program in this waiting time and whether it
has effect on functional capacity is not yet known.
Study objective
To determine whether the multimodal prehabilitation program (without extending
the time from MDT meeting to operation beyond the DLCA-S norm of 3 weeks) for
patients with NSCLC undergoing anatomical lung resection in MMC and ASz:
1. is feasible
2. results in an increased functional capacity as measured with the 6-minute
walk test, steep ramp test and 1-repetition maximum at the end-of-program (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
Study design
Multicenter pilot study. A multimodal prehabilitation program starts the day
after the MDT meeting (formal confirmation of eligibility for surgery) and ends
at hospital admission for surgery. There are 4 test moments around the
multimodal prehabilitation program: baseline (few days before start of
program), end-of-program (3-4 days before surgery), 6 weeks after surgery and 3
months after surgery.
Intervention
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 status
b) Protein and vitamin supplementation
3. Mental support
a) Medical psychologist counselling
b) (Breath) relaxation exercises
4. Smoking cessation
5. Patient empowerment & education
6. Patient optimization (directed at affected organ system)
a) Inspiratory muscle training
b) Breathing and sputum clearance techniques
Study burden and risks
Due to careful patient selection, application of exclusion criteria and the
fact that patients are deemed eligible for surgery after determining
operability as part of the preoperative work-up, potential risks of the study
are diminished. Anticipated risks are muscle/tendon injury from exercises,
transient tiredness and some minor discomforts related to nutritional
supplementation.
The maximum burden of the multimodal prehabilitation program is in case of a
complete program: 4 hospital visits for test moments, 7 hospital visits for
supervised training sessions, questionnaires at 4 test moments, 12 homebased
training days, 20 days of nutritional supplementation. For the control group
the burden will be: 4 hospital visits for test moments (including physical
examination and undergoing the study tests) and questionnaires at 4 test
moments.
Hospital visits for the study will be combined with hospital visits for
clinical purposes.
The anticipated benefit from the study in the group participating in the
multimodal prehabilitation program is an improved functional capacity and
nutritional status, and empowerment in the disease process, which in turn will
improve clinical outcome and quality of life.
For patients in the control group the anticipated benefit is insight in their
functional capacity, which might stimulate to exercise on an independent basis.
This study can only be done in patients with NSCLC undergoing anatomical
resection, because a prehabilitation program has not been investigated in this
population, which is distinctly different than e.g. patients with colorectal
cancer. Determining feasibility in this patient group is important since a
shorter waiting time until surgery is employed in this patient group than in
patients with colorectal cancer.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
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
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70578.015.19 |
| OMON | NL-OMON21254 |