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

NCT06057766 | Recruiting

• 1 other identifier: ONZ-2023-0153 - ID9994
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

Brief 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 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. 1.A wearable (Fitbit) to measure and give feedback on their daily step count.
2. 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. 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. 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).

Conditions

Non Small Cell Lung Cancer; Non-small Cell Carcinoma

Keywords

Surgery; Physical activity; coaching; telecoaching

Outcome Measures

Primary Outcomes (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.

  At randomisation, 12 weeks after randomisation

Secondary Outcomes (22)

• Mean steps per day (measured by Dynaport)

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

• Time in MVPA (moderate-to-vigorous-intense physical activity)

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

• Walking time

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

• Movement intensity during walking

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

• Sedentary time

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

Other Outcomes (9)

• Time to cancer recurrence

  1 year after the start of the intervention

• Time to return to work

  up to 2 year after finishing the 12-week intervention

• Time to new cancer-related hospital admission

  up to 2 year after finishing the 12-week intervention

Study Arms (2)

Physical activity tele coaching group

EXPERIMENTAL

Patients 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.

Other: Physical activity tele coaching program

Control group

NO INTERVENTION

Interventions

Physical activity tele coaching program OTHER

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.

Physical activity tele coaching group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Hasselt University: collaborator
• AZ Sint-Jan AV: collaborator
• AZ Delta: collaborator
• Ziekenhuis Oost-Limburg: collaborator
• Jessa Hospital: collaborator
• KU Leuven: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (6)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Hasselt University

Hasselt, Limburg, 3500, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

NOT YET RECRUITING

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

AZ Sint-Jan

Bruges, West-Vlaanderen, 8000, Belgium

RECRUITING

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Dieter Stevens, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Arents, MSc

CONTACT

003293320528; eva.arents@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: September 28, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

BE (6)