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

Non Small Cell Lung Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Lung cancer is the most commonly diagnosed cancer in men and the third most commonly diagnosed cancer in women worldwide. In Belgium specifically 8874 new cases of lung cancer were diagnosed in 2019 with a poor prognosis (five-year survival rate of 11% to 18%). Non-small cell lung cancer (NSCLC) is the most common subtype of lung cancer, accounting for approximately 85% of all cases. Survival from NSCLC is considerably better than for small-cell lung cancer (SCLC) and depends on the stage of the disease. Complete surgical resection (with or without adjuvant systemic therapy) is the preferred option for patients with resectable (stage I-IIIA) NSCLC.

Existing evidence supports the many benefits, such as blood pressure lowering, higher VO2max levels, lower mortality risk, etc. of physical activity (PA, i.e. all activities that a person performs during a day) among lung cancer survivors. PA however, is proven to be reduced in these patients. A lack of PA can contribute to the perceived symptom burden and decreased health-related quality of life in patients cured from or being treated for NSCLC.

Improving PA is a potential strategy to improve quality of life and symptom experience in these patients. This can possibly be achieved by implementing a (semi-)automated PA tele coaching program to improve PA. The efficacy and effectiveness of implementing such PA tele coaching program for operatively treated NSCLC patients will be assessed in the present study.

A previous study already showed the feasibility and effectiveness of a (semi)-automated tele coaching program (application installed on a smartphone device with real time feedback and motivational messages) and a step counter (Fitbit) providing direct feedback on total daily number of steps, walking time, time in at least moderate PA and movement intensity during walking in patients with chronic obstructive pulmonary disease (COPD).

However, studies investigating the implementation of this application in patients with NSCLC are lacking. Whereas it is clear that research on other populations cannot be generalized to cancer survivors, the investigators are convinced that this previous expertise in COPD can be translated to this population.

Patients who had lung surgery for resectable NSCLC (stage I-IIIA) one to twelve months before inclusion, with or without (neo-)adjuvant chemotherapy/radiotherapy/immunotherapy will be randomized in the intervention group or control group. Patients receiving active immunotherapy following adjuvant chemotherapy can also be included.

The intervention group will receive a 12-week individualized physical activity tele coaching program. Patients randomized in the control group will remain their usual care and will not enter the 12-week physical activity telecoaching program.

After the first 12 weeks, both groups will be followed up for another 12 weeks and also up to 1 year after randomisation.

90 Patients will be included. Patients will be randomised into the intervention or control group. Random blocks of 4 and 6, stratified by adjuvant systemic treatment (yes vs no) and centre of inclusion (Gent, Hasselt) will be used. The upcoming allocation will be concealed using the REDCap randomization module.

The aims of the present study are:

1. Primary objective:

To investigate 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.

2. Secondary objectives:

A. To investigate the effectiveness of a 12-week (semi)automated low-to-moderate intensity PA tele coaching program on physical activity (MVPA, daily walking time, movement intensity during walking, sedentary time, intensity measured as VMU relative to the VMU during 6MWT), functional exercise capacity, symptoms (dyspnea, fatigue, anxiety), quality of life, quadriceps muscle force and functional performance in resectable (stage I-IIIA) NSCLC patients after lung surgery.

B. To investigate the long-term (24 weeks after randomization) effect of a 12 week (semi)automated low intensity PA tele coaching program on physical activity, functional exercise capacity, symptoms (dyspnea, fatigue, anxiety), quality of life, quadriceps muscle force and functional performance in resectable (stage I-IIIA)NSCLC patients after lung surgery.

C. To explore the intensity of physical activity level relative to the maximal intensity performed during a six minutes walk test and relate this to the improvements in the secondary outcomes.

D.To investigate the association between changes in PA, functional exercise capacity and health-related quality of life (SF-36, EORTC-QLQ-C30, EORTC-QLQ-LC-13) and symptoms. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06057766
• Study type: Interventional
• Source: University Hospital, Ghent
• Contact: Eva Arents, MSc
• Phone: 003293320528
• Email: eva.arents@ugent.be
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: June 1, 2025