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Non Small Cell Lung CancerLucaMoveNCT06057766

Physical Activity Coaching After Surgery for Patients With Resectable Non-small Cell Lung Cancer

A study testing Physical activity tele coaching program in people with Non Small Cell Lung Cancer and Non-small Cell Carcinoma, run by University Hospital, Ghent at 6 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Physical activity tele coaching program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
6 sitesBelgium
Study dates
1 Jan 2024to 1 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Arents, MSc contact

003293320528

eva.arents@ugent.be

6 sites in 1 country

Belgium6 sites, 6 recruiting
  • AZ Sint-Jan

    Bruges, West-Vlaanderen, 8000

    Lander Van Acker, MD, 003250452660, lander.vanacker@azsintjan.be

    Lander Van Acker, MD

    Recruiting
  • Ziekenhuis Oost-Limburg

    Genk, Limburg, 3600

    Maarten Criel, MD, 003289808262, maarten.criel@zol.be

    Maarten Criel, MD

    Recruiting
  • Ghent University Hospital

    Ghent, Oost-Vlaanderen, 9000

    Eva Arents, 003293320528, eva.arents@ugent.be

    Eva Arents, Msc

    Recruiting
  • Hasselt University

    Hasselt, Limburg, 3500

    Sarah Haesevoets, MSc, 0032471431093, sarah.haesevoets@uhasselt.be

    Sarah Haesevoets, MSc

    Recruiting
  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500

    Karin Pat, MD, 003211335511, karin.pat@jessazh.be

    Karin Pat, MD

    Not yet recruiting
  • AZ Delta

    Roeselare, West-Vlaanderen, 8800

    Ingel Demedts, MD, PhD, 003251237111, ingel.demedts@azdelta.be

    Ingel Demedts, MD, PhD

    Recruiting

Other trials in Belgium

About this study

Official title: Physical Activity Coaching After Surgery for Patients With Resectable Non-small Cell Lung Cancer: a Randomized Controlled 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:

Read more

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.

Read the detailed description

Lung cancer is the most commonly diagnosed cancer in men and the third most commonly diagnosed cancer in women worldwide. In Belgium specifically 8874 new cases of lung cancer were diagnosed in 2019 with a poor prognosis (five-year survival rate of 11% to 18%). Non-small cell lung cancer (NSCLC) is the most common subtype of lung cancer, accounting for approximately 85% of all cases. Survival from NSCLC is considerably better than for small-cell lung cancer (SCLC) and depends on the stage of the disease. Complete surgical resection (with or without adjuvant systemic therapy) is the preferred option for patients with resectable (stage I-IIIA) NSCLC.

Existing evidence supports the many benefits, such as blood pressure lowering, higher VO2max levels, lower mortality risk, etc. of physical activity (PA, i.e. all activities that a person performs during a day) among lung cancer survivors. PA however, is proven to be reduced in these patients. A lack of PA can contribute to the perceived symptom burden and decreased health-related quality of life in patients cured from or being treated for NSCLC.

Improving PA is a potential strategy to improve quality of life and symptom experience in these patients. This can possibly be achieved by implementing a (semi-)automated PA tele coaching program to improve PA. The efficacy and effectiveness of implementing such PA tele coaching program for operatively treated NSCLC patients will be assessed in the present study.

A previous study already showed the feasibility and effectiveness of a (semi)-automated tele coaching program (application installed on a smartphone device with real time feedback and motivational messages) and a step counter (Fitbit) providing direct feedback on total daily number of steps, walking time, time in at least moderate PA and movement intensity during walking in patients with chronic obstructive pulmonary disease (COPD).

However, studies investigating the implementation of this application in patients with NSCLC are lacking. Whereas it is clear that research on other populations cannot be generalized to cancer survivors, the investigators are convinced that this previous expertise in COPD can be translated to this population.

Patients who had lung surgery for resectable NSCLC (stage I-IIIA) one to twelve months before inclusion, with or without (neo-)adjuvant chemotherapy/radiotherapy/immunotherapy will be randomized in the intervention group or control group. Patients receiving active immunotherapy following adjuvant chemotherapy can also be included.

The intervention group will receive a 12-week individualized physical activity tele coaching program. Patients randomized in the control group will remain their usual care and will not enter the 12-week physical activity telecoaching program.

After the first 12 weeks, both groups will be followed up for another 12 weeks and also up to 1 year after randomisation.

90 Patients will be included. Patients will be randomised into the intervention or control group. Random blocks of 4 and 6, stratified by adjuvant systemic treatment (yes vs no) and centre of inclusion (Gent, Hasselt) will be used. The upcoming allocation will be concealed using the REDCap randomization module.

The aims of the present study are:

  1. Primary objective: To investigate 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.
  2. Secondary objectives:
  3. To investigate the effectiveness of a 12-week (semi)automated low-to-moderate intensity PA tele coaching program on physical activity (MVPA, daily walking time, movement intensity during walking, sedentary time, intensity measured as VMU relative to the VMU during 6MWT), functional exercise capacity, symptoms (dyspnea, fatigue, anxiety), quality of life, quadriceps muscle force and functional performance in resectable (stage I-IIIA) NSCLC patients after lung surgery.
  4. To investigate the long-term (24 weeks after randomization) effect of a 12 week (semi)automated low intensity PA tele coaching program on physical activity, functional exercise capacity, symptoms (dyspnea, fatigue, anxiety), quality of life, quadriceps muscle force and functional performance in resectable (stage I-IIIA)NSCLC patients after lung surgery.
  5. To explore the intensity of physical activity level relative to the maximal intensity performed during a six minutes walk test and relate this to the improvements in the secondary outcomes.

D.To investigate the association between changes in PA, functional exercise capacity and health-related quality of life (SF-36, EORTC-QLQ-C30, EORTC-QLQ-LC-13) and symptoms.

Being tested
Physical activity tele coaching program
Keywords
Surgery, Physical activity, coaching, telecoaching
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity tele coaching programOther

    The 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.

Study groups in NCT06057766
Study groupRoleWhat they receive
Physical activity tele coaching groupExperimentalPatients in the experimental group will undertake a 12-week (semi)automated telecoaching program with the aim of enhancing their physical activity. The program uses a Fitbit wearable and a smartphone application that is developed for and tested to be effective for patients with COPD.
Receives: Other: Physical activity tele coaching program
Control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At randomisation, 12 weeks after randomisation

Secondary outcomes (22)
  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.

    Measured: 24 weeks after randomisation, 1 year after the start of the intervention

  2. 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.

    Measured: at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  3. 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.

    Measured: at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  4. 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.

    Measured: at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  5. Sedentary time

    Change in sedentary time, objectively measured by avalidated tri-axial accelerometer (Actigraph) 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.

    Measured: at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  6. Physical activity intensity measured as VMU (Actigraph) relative to the VMU during 6MWT

    A clinically relevant test to measure a patient's exercise capacity is the 6MWT. During this 6MWT the maximal intensity that a patient reaches during the test will be instrumented by the Actigraph. As the maximal intensity we will retrieve the mean VMU during the 6MWT. Day-by-day intensity can then be expressed as a % of this maximum.

    Measured: AT randomisation, during week 4 and 8 of the intervention and follow-up period, 12 weeks after randomisation, 24 weeks after raondomsation

  7. Functional exercise capacity measured by 6MWT

    Functional exercise capacity will be measured using a six-minute walk distance (6MWD) test. This test is a routinely used, valid, reliable and safe exercise test in patients with chronic respiratory diseases. The test is standardized in a 30m corridor and will be performed according to the protocol proposed by ERS/ATS.

    Heart rate and oxygen saturation are measured before, during and after the test. Symptom scores for dyspnea and leg fatigue are assessed, at the beginning and end of the test, by the BORG scale. The 6MWD will be measured twice per visit.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation

  8. Functional exercise capacity measured by 1-min sit-to-stand

    Functional exercise capacity will be measured by a 1-min sit-to-stand (1MSTS) test and is a reliable, valid and responsive test for measuring functional exercise capacity in COPD patients. The 6MWD will be measured twice per visit.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation

  9. Symptoms of dyspnea

    The San Diego Shortness of Breath Questionnaire (SOBQ) will be used to assess self-reported shortness of breath while performing activities of daily living. Scores range from 0 (better) to 120 (worse).

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation; 1 year after the start of the intervention

  10. Symptoms of fatigue

    Measured by Functional Assessment of Chronic Illness Treatment-Fatigue (FACIT-F). Maximum score is 160 and minimum score is 0. The higher the score, the better the quality of life.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  11. Symptoms of anxiety, stress and depression

    Measured by the Depression, Anxiety and Stress scale (short-form) (DASS-21). For each scale it is needed to sum the scores for identified items. Because the DASS-21 is a short form version of the DASS (the long form has 42 items), the final score of each item groups needs to be multiplied by 2.

    Interpretation of Depression score: 0-4=normal, 5-6=mild, 7-10=moderate, 11-13=severe, 14+=extremely severe.

    Interpretation of Anxiety score: 0-3=normal, 4-5=mild, 6-7=moderate, 8-9=severe, 10+=extremely severe.

    Interpretation of Stress score: 0-7=normal, 8-9=mild, 10-12=moderate, 13-16=severe, 17+=extremely severe.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  12. Symptoms of loneliness

    The UCLA Loneliness Scale provides a reliable and valid assessment of loneliness across a variety of populations and data-collection methods. The total score ranges from 20 to 80. Higher scores indicate higher loneliness. The most commonly used categorization is the following: 20-34 denotes a low degree of loneliness, 35-49 a moderate degree of loneliness, 50-64 a moderately high degree of loneliness, and 65-80 a high degree of loneliness.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  13. Health related quality of life measured by EORTC QLQ-C30-LC13

    The European Organization for the Research and Treatment of Cancer Questionnaire and lung cancer module (EORTC QLQ-C30-LC13) is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer patients participating in clinical trials, when combined with the EORTC core quality of life questionnaire. Scores for the EORTC-C30-QLQ and the lung cancer module each range from 0-100. Higher scores indicate a higher quality of life.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  14. General health status measured by SF-36

    Measured by the 36-item Short Form Survey (SF-36). SF-36 scores range from 0 (worst) to 100 (best). Higher scores indicate a better quality of life.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  15. General health status measured by EQ-5D-5L

    The EQ-5D is a short questionnaire to assess general health status. There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health). The instrument also includes a visual analogue scale (EQ-VAS) which provides a single global rating of self-perceived health and is scored on a 0 to 100 mm scale representing "the worst…" and "the best health you can imagine", respectively.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  16. Motivation and self-efficacy measured by Exercise Self-Efficacy Scale (ESES)

    The Exercise Self-Efficacy Scale (ESES) is a scale developed to measure a person's beliefs or confidence that they can perform various physical activities and exercise on a scale of 1-4. Scores range from 10 (worst) to 40 (best).

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  17. Self-efficacy by the modified Tampa Scale for Kinesiophobia (TSK)

    The modified Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that quantifies fear of movement [32]. Scores range from 17 (best) - 68 (worst).

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  18. Self-efficacy measured by Perceived physical activity scale

    The LIVAS is a questionnaire, tapping how a person perceives his or her physical abilities. The scale is based on the Perceived Physical Ability (PPA) scale (Ryckman et al., 1982). The questionnaire consists of 10 items, asking subjects to evaluate their physical abilities compared to other people of their own age.

    The items have to be rated on a five-point scale.The scale scores therefore vary between 10 and 50. Higher scores represent more positive physical self-efficacy beliefs.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  19. Self-efficacy measured by self-Regulated Questionnaire-Exercise (SRQ-E)

    The self-Regulated Questionnaire-Exercise (SRQ-E) is a validated 16-item instrument including four regulation subscales used to assesses regulation styles (i.e., intrinsic motivation, identified regulation, introjected regulation and external regulation) in the participants. Using this instrument, participants will be asked reasons for exercising on a regular basis. There are four different types of behavioral regulation. They are external regulation, introjected regulation, identified regulation, and integrated regulation, in order from the least to the most fully internalized. Each participant gets a score on each subscale by averaging responses to each of the items that make up that subscale--for example, the average of all items representing introjected regulation would represent the score for that subscale.

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  20. Real time assessment of experience and behaviour

    Measured by Ecological Momentary Assessment (EMA) measured by m-Path smartphone application

    Measured: At randomisation, during week 4 and 8 of the intervention and follow-up period, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention

  21. Functional performance

    Measured by the Short Physical Performance Battery (SPPB)This test assesses lower extremity function and mobility. It consists of 3 subtests that are scored and points are added up:

    1. 4-meter gait speed
    2. 5 times sit to stand
    3. Balance test: In this test, patients take specific positions (side by side stand, semi-tandem stand and tandem stand) for a maximum of 10 seconds after demonstration of each foot position. Progressively the foot positions become more difficult.

    Rating of the SPPB: Each task is scored out of 4 (0: worst performance - 4: best performance), with a total score from the tree subtests ranging from 0 (lower level of function) to 12 (higher level of function).

    Measured: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation

  22. Sleep Quality

    The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality and patterns over the last month. The questionnaire consists of 19 items, divided into 7 domains: duration of sleep, sleep disturbance, sleep latency, day dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and the need for medications to sleep. The PSQI has a total score between 0 and 21, where higher scores indicate a lower sleep quality. A score of 5 or more often indicates clinically significant sleep problems.

    Measured: At randomisation, during week 4 and 8 of the intervention and follow-up period, 12 weeks after the randomization, 24 weeks after randomization and 1 year after the start of the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start1 Jan 2024
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057766
Sponsor's protocol ID
ONZ-2023-0153 - ID9994
Acronym
LucaMove
Status last verified
Nov 2025
First submitted
22 Jun 2023
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity tele coaching program in people with Non Small Cell Lung Cancer and Non-small Cell Carcinoma, run by University Hospital, Ghent at 6 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Arents, MSc (003293320528, eva.arents@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean steps per day (time frame: At randomisation, 12 weeks after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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LucaMove Clinical Trial NCT06057766 | AzTrials