NCT06057766 Physical Activity Coaching After Surgery for Patients With Resectable Non-small Cell Lung Cancer
| NCT ID | NCT06057766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-01-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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) * Patients who do not systematically perform structured exercise or are planned to do so. * Ability to give informed consent Exclusion Criteria: * 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) * Not understanding and speaking Dutch * Patients with comorbidities or other treatments that preclude them from participation in a physical activity intervention and/or performing the test battery
Contact & Investigator
Dieter Stevens, MD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT06057766 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06057766 currently recruiting?
Yes, NCT06057766 is actively recruiting participants. Contact the research team at eva.arents@ugent.be for enrollment information.
Where is the NCT06057766 trial being conducted?
This trial is being conducted at Genk, Belgium, Hasselt, Belgium, Hasselt, Belgium, Ghent, Belgium and 2 additional locations.
Who is sponsoring the NCT06057766 clinical trial?
NCT06057766 is sponsored by University Hospital, Ghent. The principal investigator is Dieter Stevens, MD at University Hospital, Ghent. The trial plans to enroll 90 participants.
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