Investigating the Feasibility of a Physical Activity (tele)coaching Intervention in Patients with Non-small Cell Lung Cancer: an Explorative Study

NCT05569291 | Completed

• 1 other identifier: 2021/160
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-small Cell Lung Cancer; Non-small Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Physical activity

  1 whole week after inclusion and 1 whole week after the 8-week intervention

• Functional exercise capacity

  1 week before the start of the intervention and immediately after the 8-week intervention

• Symptoms

  1 week before the start of the intervention and immediately after the 8-week intervention

• Quality of Life - EORTC QLQ-C30-LC13

  1 week before the start of the intervention and immediately after the 8-week intervention

Study Arms (2)

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.

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.

Other: Manual Coaching Program (MCP)

Interventions

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.

Automated Coaching Program (ACP)

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.

Manual Coaching Program (MCP)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Three to nine months after a lung resection surgery for non-small cell lung cancer
• Adults (+18 year)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• University Ghent: collaborator
• Jessa Hospital: collaborator
• University Hospital, Ghent: collaborator

Study Sites (2)

REVAL Gebouw A

Diepenbeek, Limburg, 3590, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chris Burtin, PhD

  University Hasselt

  PRINCIPAL INVESTIGATOR

• Heleen Demeyer, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 6, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)