Physical Activity Coaching After Surgery for Patients With Resectable Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent
About this trial
The goal of this randomized controlled clinical trial is to test a 12-week physical activity telecoaching program for NSCLC patients after surgery.
The main question it aims to answer is:
What is the effectiveness and acceptability of a 12-week (semi)automated low-to-moderate intensity PA tele coaching program on physical activity (mean steps per day) in resectable (stage I-IIIA) NSCLC patients after lung surgery, as compared to usual care?
Patients with NSCLC will be enrolled in the study from 1 month postoperatively up to 1 year postoperatively. They will be randomized in either the intervention group or the control group.
Patients randomized in the intervention group will be asked to enter a 12-week physical activity telecoaching program with the aim to enhance their physical activity. The telecoaching programs consists of 4 pilars:
1. A wearable (Fitbit) to measure and give feedback on their daily step count. 2. A smartphone coaching application, installed on a smartphone and linked to the wearable, providing automated coaching by displaying an individual activity goal (expressed as daily step count) and daily and weekly feedback on the performance (steps) of the patient. 3. A one-to-one semi-structured interview with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favourite activities, and (coping) strategies to become more active resulting in an individual action plan. 4. Phone calls by the coaches initiated in pre-defined situations (non-compliance with wearing the step counter, failure to transmit the data, failure to progress).
Patients randomized in the control group will remain their usual care and will not enter the 12-week physical activity telecoaching program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Resectable (I-IIIA) NSCLC patients who had lung resection surgery, one to twelve months before inclusion, with or without (neo-)adjuvant chemotherapy/radiotherapy/immunotherapy.
If patients received adjuvant chemotherapy/radiotherapy, the inclusion window is one months to twelve months after the end of adjuvant chemotherapy/radiotherapy.
If patients receive adjuvant immunotherapy after the end of adjuvant chemotherapy, patients can be included during the immunotherapy.
Adults (18+ year)
Disqualifiers
Patients having progressive or recurrent lung cancer
Patients who had other malignancies in the last 2 years
Psychiatric disorders that preclude them from participation in a physical activity intervention and/or performing the test battery
Unable to learn to work with a new electronic device (e.g. smartphone)
Trial design
Design model
Parallel
Treatments tested in this trial
Physical activity tele coaching program
Other interventionThe program includes 1. one-to-one semi-structured interview with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favourite activities, and (coping) strategies to become more active resulting in an individual action plan; 2. step counter (Fitbit) providing direct feedback which automatically sends data to the smartphone via blue-tooth. Patients will be asked to wear this step counter every day during the intervention; 3. smartphone coaching application (mPAC), installed on a smartphone and linked to the step counter, will provide automated coaching by displaying an individual activity goal (expressed as daily step count) and daily and weekly feedback on the performance (steps) of the patient. 4. phone calls by the coaches initiated in pre-defined situations (non-compliance with wearing the step counter, failure to transmit the data, failure to progress). Evidence-based behaviour change techniques will be implemented.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Physical activity tele coaching groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mean steps per day
Change in physical activity (mean steps per day), objectively measured by avalidated tri-axial accelerometer (Dynaport MoveMonitor) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3 valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.
Time frame
At randomisation, 12 weeks after randomisationSecondary outcomes
1
Mean steps per day (measured by Dynaport)
Change in physical activity (mean steps per day), objectively measured by avalidated tri-axial accelerometer (Dynaport MoveMonitor) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.
Time frame
24 weeks after randomisation, 1 year after the start of the intervention2
Time in MVPA (moderate-to-vigorous-intense physical activity)
Change in time in MVPA, objectively measured by avalidated tri-axial accelerometer (Actigraph) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3valid weekdays (\>8 hours of wearing time during the day) is necessary to label thisas a valid measurement.
Time frame
at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention3
Walking time
Change in walking time, objectively measured by avalidated tri-axial accelerometer (Dynaport Movemonitor) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3 valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.
Time frame
at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention4
Movement intensity during walking
Change in movement intensity during walking, objectively measured by avalidated tri-axial accelerometer (Dynaport Movemonitor) after a 12-week(semi)automated low-to-moderate intensity PA tele coaching program. At least 3 valid weekdays (\>8 hours of wearing time during the day) is necessary to label this as a valid measurement.
Time frame
at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the interventionOther outcomes
1
Time to cancer recurrence
by having access to the patients' file for 2years
Time frame
1 year after the start of the intervention2
Time to return to work
by having access to the patients' file for 2years
Time frame
up to 2 year after finishing the 12-week intervention3
Time to new cancer-related hospital admission
by having access to the patients' file for 2years
Time frame
up to 2 year after finishing the 12-week intervention4
Need for follow-up cancer treatment.
Is there need for follow-up cancer treatment? Will be documented by having access to the patients' file for 2years
Time frame
up to 2 year after finishing the 12-week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
Hasselt University
Collaborator
AZ Sint-Jan AV
Collaborator
AZ Delta
Collaborator
Ziekenhuis Oost-Limburg
Collaborator
Jessa Hospital
Collaborator
KU Leuven
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Source ClinicalTrials.gov