Investigating the Feasibility of a Physical Activity (Tele)Coaching Intervention in Patients With Non-small Cell Lung Cancer: an Explorative Study

Non-small Cell Lung Cancer Clinical Trial

— LUCA-coach  

Official title:

Investigating the Feasibility of a Physical Activity (Tele)Coachingv Intervention in Patients With Non-small Cell Lung Cancer: an Explorative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569291
• Other study ID #: 2021/160
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2023
• Source: Hasselt University
• Contact: Sarah Haesevoets, MSc
• Phone: +3211268996
• Email: sarah.haesevoets[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Carcinoma
• Non-small Cell Lung Cancer

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Belgium	REVAL Gebouw A	Diepenbeek	Limburg
Belgium	UZ Gent	Gent	Oost-Vlaanderen

Sponsors (4)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital, University Ghent, University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 weeks after the inclusion of the patient
Primary	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.	During the whole 8-week intervention
Primary	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.	9 weeks after the inclusion of the patient
Primary	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.	During the whole 8-week intervention
Secondary	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.	1 whole week after inclusion and 1 whole week after the 8-week intervention
Secondary	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.	1 week before the start of the intervention and immediately after the 8-week intervention
Secondary	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.	1 week before the start of the intervention and immediately after the 8-week intervention
Secondary	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.	1 week before the start of the intervention and immediately after the 8-week intervention