Physical Activity Coaching After Surgery for Patients with Resectable Non-small Cell Lung Cancer: a Randomized Controlled Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. A wearable (Fitbit) to measure and give feedback on their daily step count. 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. 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. 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). Patients randomized in the control group will remain their usual care and will not enter the 12-week physical activity telecoaching program.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Resectable (I-IIIA) NSCLC patients who had lung resection surgery, one to twelve months before inclusion, with or without (neo-)adjuvant chemotherapy/radiotherapy/immunotherapy.

• If patients received adjuvant chemotherapy/radiotherapy, the inclusion window is one months to twelve months after the end of adjuvant chemotherapy/radiotherapy.

• 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

Locations
Other Locations
Belgium
AZ Sint-Jan
RECRUITING
Bruges
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Ghent University Hospital
RECRUITING
Ghent
Hasselt University
RECRUITING
Hasselt
Jessa Ziekenhuis
NOT_YET_RECRUITING
Hasselt
AZ Delta
RECRUITING
Roeselare
Contact Information
Primary
Eva Arents, MSc
eva.arents@ugent.be
003293320528
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 90
Treatments
Experimental: Physical activity tele coaching group
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.
No_intervention: Control group
Sponsors
Collaborators: AZ Delta, AZ Sint-Jan AV, Jessa Hospital, Hasselt University, Ziekenhuis Oost-Limburg
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov

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