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

Primary Purpose

Non-small Cell Lung Cancer, Non-small Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Automated Coaching Program (ACP)
Manual Coaching Program (MCP)
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • REVAL Gebouw ARecruiting
  • UZ GentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Automated Coaching Program (ACP)

Manual Coaching Program (MCP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 16, 2022
Last Updated
October 18, 2023
Sponsor
Hasselt University
Collaborators
University Ghent, Jessa Hospital, University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05569291
Brief Title
Investigating the Feasibility of a Physical Activity (Tele)Coaching Intervention in Patients With Non-small Cell Lung Cancer: an Explorative Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
University Ghent, Jessa Hospital, University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Non-small Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Automated Coaching Program (ACP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual Coaching Program (MCP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Automated Coaching Program (ACP)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Coaching Program (MCP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of the coaching programs
Description
(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.
Time Frame
9 weeks after the inclusion of the patient
Title
Actual usage of the coaching programs
Description
(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.
Time Frame
During the whole 8-week intervention
Title
Feasibility of the coaching programs
Description
(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.
Time Frame
9 weeks after the inclusion of the patient
Title
Safety of the coaching programs
Description
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.
Time Frame
During the whole 8-week intervention
Secondary Outcome Measure Information:
Title
Physical activity
Description
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.
Time Frame
1 whole week after inclusion and 1 whole week after the 8-week intervention
Title
Functional exercise capacity
Description
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.
Time Frame
1 week before the start of the intervention and immediately after the 8-week intervention
Title
Symptoms
Description
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.
Time Frame
1 week before the start of the intervention and immediately after the 8-week intervention
Title
Quality of Life - EORTC QLQ-C30-LC13
Description
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.
Time Frame
1 week before the start of the intervention and immediately after the 8-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Haesevoets, MSc
Phone
+3211268996
Email
sarah.haesevoets@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Arents, MSc
Phone
+3293320528
Email
eva.arents@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Burtin, PhD
Organizational Affiliation
University Hasselt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heleen Demeyer, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
REVAL Gebouw A
City
Diepenbeek
State/Province
Limburg
ZIP/Postal Code
3590
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Burtin, PhD
Email
chris.burtin@uhasselt.be
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heleen Demeyer, PhD
Email
h.demeyer@ugent.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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