Clinical trial NCT06057766: Physical Activity Coaching After Surgery for Patients with Resectable Non-small Cell Lung Cancer
Official title: Physical Activity Coaching After Surgery for Patients with Resectable Non-small Cell Lung Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Non-small Cell Carcinoma
Keywords: Surgery
Physical activity
coaching
telecoaching
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Hasselt University
name: AZ Sint-Jan AV
name: AZ Delta
name: Ziekenhuis Oost-Limburg
name: Jessa Hospital
First posted: 2023-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean steps per day
timeFrame: At randomisation, 12 weeks after randomisation
Secondary outcomes:
measure: Mean steps per day (measured by Dynaport)
timeFrame: 24 weeks after randomisation, 1 year after the start of the intervention
measure: Time in MVPA (moderate-to-vigorous-intense physical activity)
timeFrame: at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Walking time
timeFrame: at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Movement intensity during walking
timeFrame: at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Sedentary time
timeFrame: at randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Physical activity intensity measured as VMU (Actigraph) relative to the VMU during 6MWT
timeFrame: AT randomisation, during week 4 and 8 of the intervention and follow-up period, 12 weeks after randomisation, 24 weeks after raondomsation
measure: Functional exercise capacity measured by 6MWT
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation
measure: Functional exercise capacity measured by 1-min sit-to-stand
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation
measure: Symptoms of dyspnea
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation; 1 year after the start of the intervention
measure: Symptoms of fatigue
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Symptoms of anxiety, stress and depression
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Symptoms of loneliness
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Health related quality of life measured by EORTC QLQ-C30-LC13
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: General health status measured by SF-36
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: General health status measured by EQ-5D-5L
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Motivation and self-efficacy measured by Exercise Self-Efficacy Scale (ESES)
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Self-efficacy by the modified Tampa Scale for Kinesiophobia (TSK)
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Self-efficacy measured by Perceived physical activity scale
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Self-efficacy measured by self-Regulated Questionnaire-Exercise (SRQ-E)
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Real time assessment of experience and behaviour
timeFrame: At randomisation, during week 4 and 8 of the intervention and follow-up period, 12 weeks after randomisation, 24 weeks after randomisation, 1 year after the start of the intervention
measure: Functional performance
timeFrame: At randomisation, 12 weeks after randomisation, 24 weeks after randomisation
Other outcomes:
measure: Time to cancer recurrence
timeFrame: 1 year after the start of the intervention
measure: Time to return to work
timeFrame: up to 2 year after finishing the 12-week intervention
measure: Time to new cancer-related hospital admission
timeFrame: up to 2 year after finishing the 12-week intervention
measure: Need for follow-up cancer treatment.
timeFrame: up to 2 year after finishing the 12-week intervention
measure: Type of follow-up cancer treatment.
timeFrame: up to 2 year after finishing the 12-week intervention
measure: Time to death
timeFrame: up to 2 year after finishing the 12-week intervention
measure: Adverse events
timeFrame: up to 2 year after finishing the 12-week intervention
measure: Patient experience
timeFrame: 12 weeks after randomisation, 24 weeks after randomisation
measure: Patient experience
timeFrame: 12 weeks after randomisation, 24 weeks after randomisation
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta
state: West-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Dieter Stevens, MD
role: PRINCIPAL_INVESTIGATOR
References: