Non-small Cell Lung CancerLUCA-coachNCT05569291
Investigating the Feasibility of a Physical Activity (tele)coaching Intervention in Patients with Non-small Cell Lung Cancer: an Explorative Study
A study testing Automated Coaching Program (ACP) and Manual Coaching Program (MCP) in people with Non-small Cell Lung Cancer and Non-small Cell Carcinoma, run by Hasselt University at 2 sites in Belgium.
Trial summary
The aim of this study is to investigate the acceptability, actual usage, feasibility and safety of 1) a (semi) automated PA tele coaching intervention including smartphone application and stepcounter (Fitbit Charge 4) and 2) a manual PA tele coaching program using only a stepcounter (Fitbit Charge 4) without custom… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Non-small Cell Carcinoma
- What is being tested?
- Automated Coaching Program (ACP) and Manual Coaching Program (MCP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Oct 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Three to nine months after a lung resection surgery for non-small cell lung cancer
- If patients received adjuvant chemotherapy, the inclusion window will be three months to nine months after the end of adjuvant chemotherapy
- Adults (+18 year)
Who cannot join
- Progressive or recurrent lung cancer
- Who had other malignancies in the last 2 years
- Psychiatric disorders
- Other ongoing treatments
- Involved in or planned to start a multidisciplinary rehabilitation program
- Unable to learn to work with a new electronic device (e.g. smartphone)
- Not understanding and speaking Dutch
- Patients with comorbidities precluding them from participation in a physical activity intervention
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
REVAL Gebouw A
Diepenbeek, Limburg, 3590
UZ Gent
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: Investigating the Feasibility of a Physical Activity (tele)coachingv Intervention in Patients with Non-small Cell Lung Cancer: an Explorative Study
The aim of this study is to investigate the acceptability, actual usage, feasibility and safety of 1) a (semi) automated PA tele coaching intervention including smartphone application and stepcounter (Fitbit Charge 4) and 2) a manual PA tele coaching program using only a stepcounter (Fitbit Charge 4) without custom smartphone application but still linked with a smartphone using the Fitbit application and to make population specific adaptations to the intervention for patients with NSCLC after lung resection surgery.
- Being tested
- Automated Coaching Program (ACP), Manual Coaching Program (MCP)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Coaching Program (ACP)Device
A semiautomated tele coaching program (application installed on a smartphone device with real time feedback and motivational messages) and a step counter (Fitbit Charge 4) providing direct feedback on total daily number of steps, walking time, time in at least moderate PA and movement intensity during walking.
Manual Coaching Program (MCP)Other
A telecoaching program using a step counter (Fitbit Charge 4) without this custom smartphone application but with the Fitbit application. This intervention will be more focused on weekly personal feedback from a coach by telephone.
| Study group | Role | What they receive |
|---|---|---|
| Automated Coaching Program (ACP) | Experimental | The ACP will use the application as developed for patients with COPD and tested to be effective in this population (Demeyer et al., 2017). The program includes 1) one-to-one semi-structured interview (V1) with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favorite activities and (coping) strategies to become more active resulting in an individual action plan; 2) step counter (Fitbit; wrist or waist worn) 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, 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. Receives: Device: Automated Coaching Program (ACP) |
| Manual Coaching Program (MCP) | Experimental | The MCP includes 1) one-to-one semi-structured interview (V1) with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favorite activities and (coping) strategies to become more active resulting in an individual action plan; 2) step counter (Fitbit, wrist or waist worn), that will be linked with a smartphone using the Fitbit application providing direct feedback. Patients can access the Fitbit application if they want to, but they will not receive personal feedback; 3) weekly phone calls by the coaches, interviewing patients on their progress, performance (steps) and feedback. The first goal is based on the physical activity level at the beginning of the coaching intervention (median of 4 days). The individual activity goal (expressed as daily step count) will be revised based on the patient's willingness to increase. Receives: Other: Manual Coaching Program (MCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the coaching programs
(i.e. to what extent patients receiving the intervention consider it as appropriate) Acceptability will be assessed through quantitative data (a project-tailored questionnaire) and qualitative data collection (patient interview with open questions).
Patients will be asked to fill in a self-administered, project-tailored, multiple choice questionnaire on their experiences with the intervention.
Patient interviews with open questions will be conducted by the local PA coach in each center.
Measured: 9 weeks after the inclusion of the patient
Actual usage of the coaching programs
(i.e. the degree to which patients use the components of the intervention as it was designed) Actual usage of the custom application by patients will be assessed objectively through the smartphone app log (for participants in the ACP group). This will include information about completion of the app tasks and step counter data on a day-by-day basis and will be automatically collected in the back-end of the application.
Actual usage of the step counter (for participants in both intervention groups) will be defined based on the presence of step count data (ie, ≥70 steps for that day). The frequency at which patients looked at their step counter will be assessed subjectively in the project-tailored questionnaire.
Measured: During the whole 8-week intervention
Feasibility of the coaching programs
(i.e. the extent to which the treatment can be successfully used within a given setting). Feasibility will be assessed through quantitative data (a project-tailored questionnaire) and qualitative data collection (patient interview with open questions).
Patients will be asked to report the smartphone intervention and use of the step counter and indicate if it was not too much of a burden to work with when they are asked how they have experienced the technical aspects of the intervention. Coaches will collect contact time with patients and preparation time in a logbook in an Excel file. Also, how many times patients are contacted and the number of technical problems will be collected.
Measured: 9 weeks after the inclusion of the patient
Safety of the coaching programs
Detailed information of any adverse event (AE) will be collected during the pilot phase. Description, severity, start and stop, seriousness, outcome and relation to the intervention will be described for every reported AE. If problems occur during the intervention, patients are asked to contact the coach to discuss possible AE's. If necessary, an extra visit or consultation with a physician will be scheduled. During each patient contact coaches will also seek information on AE's. All events, whether reported by the patient or noted by the coach, will be recorded in the patient's medical record and in the (e)CRF within a reasonable time after becoming aware.
Measured: During the whole 8-week intervention
Secondary outcomes (4)
Physical activity
PA will be objectively measured using the Dynaport Movemonitor (DAM, McRoberts, The Hague, The Netherlands), a small (106.6 x 58 x 11.5mm), light-weight CE marked tri-axial accelerometer with a sampling frequency of 100Hz. The Dynaport Movemonitor analyzes and expresses digital data not only in terms of locomotion and movement parameters, but also in terms of body posture. Data will be processed with commercially available software (MoveMonitor; McRoberts B.V., The Hague, The Netherlands). The monitor will be worn at the waist level using a comfortable elastic strap.
Patients will wear the monitor during 1 week before and after the intervention. They will be asked to wear the device continuously, except during bathing/showering and sleeping. Days with less than 8 hours of wearing time will be excluded from the analysis. Patients will not be included in the analysis if they did not have at least 4 valid weekdays of measurement.
Measured: 1 whole week after inclusion and 1 whole week after the 8-week intervention
Functional exercise capacity
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: 1 week before the start of the intervention and immediately after the 8-week intervention
Symptoms
The modified medical research council (MMRC) dyspnea scale is a simple one- question grading system to assess the patient's symptoms of breathlessness in daily life. The Multidimensional Fatigue Inventory (MFI-20) is a 20-item self-report instrument designed to measure fatigue, a cardinal symptom in cancer survivors. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue.
Measured: 1 week before the start of the intervention and immediately after the 8-week intervention
Quality of Life - 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.
Measured: 1 week before the start of the intervention and immediately after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Jessa Hospital, University Hospital, Ghent
- Responsible party
- Principal investigator, Chris Burtin, Hasselt University
- Investigators
- Chris Burtin, PhD, Principal investigator, University HasseltHeleen Demeyer, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569291
- Sponsor's protocol ID
- 2021/160
- Acronym
- LUCA-coach
- Status last verified
- Oct 2024
- First submitted
- 16 Sep 2022
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility of a Physical Activity (tele)coachingv Intervention in Patients with Non-small Cell Lung Cancer: an Explorative Study
- ClinicalTrials.gov ID
- NCT05569291
- Acronym / sponsor ID
- LUCA-coach / 2021/160
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- University Ghent, Jessa Hospital, University Hospital, Ghent
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the acceptability, actual usage, feasibility and safety of 1) a (semi) automated PA tele coaching intervention including smartphone application and stepcounter (Fitbit Charge 4) and 2) a manual PA tele coaching program using only a stepcounter (Fitbit Charge 4) without custom smartphone application but still linked with a smartphone using the Fitbit application and to make population specific adaptations to the intervention for patients with NSCLC after lung resection surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated Coaching Program (ACP) | Experimental | Device: Automated Coaching Program (ACP)The ACP will use the application as developed for patients with COPD and tested to be effective in this population (Demeyer et al., 2017). The program includes 1) one-to-one semi-structured interview (V1) with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favorite activities and (coping) strategies to become more active resulting in an individual action plan; 2) step counter (Fitbit; wrist or waist worn) 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, 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. |
| Manual Coaching Program (MCP) | Experimental | Other: Manual Coaching Program (MCP)The MCP includes 1) one-to-one semi-structured interview (V1) with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favorite activities and (coping) strategies to become more active resulting in an individual action plan; 2) step counter (Fitbit, wrist or waist worn), that will be linked with a smartphone using the Fitbit application providing direct feedback. Patients can access the Fitbit application if they want to, but they will not receive personal feedback; 3) weekly phone calls by the coaches, interviewing patients on their progress, performance (steps) and feedback. The first goal is based on the physical activity level at the beginning of the coaching intervention (median of 4 days). The individual activity goal (expressed as daily step count) will be revised based on the patient's willingness to increase. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Three to nine months after a lung resection surgery for non-small cell lung cancer
- If patients received adjuvant chemotherapy, the inclusion window will be three months to nine months after the end of adjuvant chemotherapy
- Adults (+18 year)
Key exclusion criteria (8 listed)
- Progressive or recurrent lung cancer
- Who had other malignancies in the last 2 years
- Psychiatric disorders
- Other ongoing treatments
- Involved in or planned to start a multidisciplinary rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Coaching Program (ACP)A semiautomated tele coaching program (application installed on a smartphone device with real time feedback and motivational messages) and a step counter (Fitbit Charge 4) providing direct feedback on total daily number of steps, walking time, time in at least moderate PA and movement intensity during walking. | Device | Automated Coaching Program (ACP) |
| Manual Coaching Program (MCP)A telecoaching program using a step counter (Fitbit Charge 4) without this custom smartphone application but with the Fitbit application. This intervention will be more focused on weekly personal feedback from a coach by telephone. | Other | Manual Coaching Program (MCP) |
Primary outcome
Acceptability of the coaching programs
Time frame: 9 weeks after the inclusion of the patient
(i.e. to what extent patients receiving the intervention consider it as appropriate) Acceptability will be assessed through quantitative data (a project-tailored questionnaire) and qualitative data collection (patient interview with open questions). Patients will be asked to fill in a self-administered, project-tailored, multiple choice questionnaire on their experiences with the intervention. Patient interviews with open questions will be conducted by the local PA coach in each center.
Actual usage of the coaching programs
Time frame: During the whole 8-week intervention
(i.e. the degree to which patients use the components of the intervention as it was designed) Actual usage of the custom application by patients will be assessed objectively through the smartphone app log (for participants in the ACP group). This will include information about completion of the app tasks and step counter data on a day-by-day basis and will be automatically collected in the back-end of the application. Actual usage of the step counter (for participants in both intervention groups) will be defined based on the presence of step count data (ie, ≥70 steps for that day). The frequency at which patients looked at their step counter will be assessed subjectively in the project-tailored questionnaire.
Feasibility of the coaching programs
Time frame: 9 weeks after the inclusion of the patient
(i.e. the extent to which the treatment can be successfully used within a given setting). Feasibility will be assessed through quantitative data (a project-tailored questionnaire) and qualitative data collection (patient interview with open questions). Patients will be asked to report the smartphone intervention and use of the step counter and indicate if it was not too much of a burden to work with when they are asked how they have experienced the technical aspects of the intervention. Coaches will collect contact time with patients and preparation time in a logbook in an Excel file. Also, how many times patients are contacted and the number of technical problems will be collected.
Safety of the coaching programs
Time frame: During the whole 8-week intervention
Detailed information of any adverse event (AE) will be collected during the pilot phase. Description, severity, start and stop, seriousness, outcome and relation to the intervention will be described for every reported AE. If problems occur during the intervention, patients are asked to contact the coach to discuss possible AE's. If necessary, an extra visit or consultation with a physician will be scheduled. During each patient contact coaches will also seek information on AE's. All events, whether reported by the patient or noted by the coach, will be recorded in the patient's medical record and in the (e)CRF within a reasonable time after becoming aware.
4 secondary outcomes
Physical activity
Time frame: 1 whole week after inclusion and 1 whole week after the 8-week intervention
Functional exercise capacity
Time frame: 1 week before the start of the intervention and immediately after the 8-week intervention
Symptoms
Time frame: 1 week before the start of the intervention and immediately after the 8-week intervention
Quality of Life - EORTC QLQ-C30-LC13
Time frame: 1 week before the start of the intervention and immediately after the 8-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Burtin, PhD principal investigator
University Hasselt
Heleen Demeyer, PhD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Coaching Program (ACP) and Manual Coaching Program (MCP) in people with Non-small Cell Lung Cancer and Non-small Cell Carcinoma, run by Hasselt University at 2 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the coaching programs (time frame: 9 weeks after the inclusion of the patient). The study lists 4 primary outcomes in all. 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 4 Oct 2024.