Clinical trial NCT05569291: Investigating the Feasibility of a Physical Activity (tele)coaching Intervention in Patients with Non-small Cell Lung Cancer: an Explorative Study
Official title: Investigating the Feasibility of a Physical Activity (tele)coachingv Intervention in Patients with Non-small Cell Lung Cancer: an Explorative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Non-small Cell Carcinoma
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Jessa Hospital
name: University Hospital, Ghent
First posted: 2022-10-06
Enrollment: 19
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Three to nine months after a lung resection surgery for non-small cell lung cancer
* If patients received adjuvant chemotherapy, the inclusion window will be three months to nine months after the end of adjuvant chemotherapy
* Adults (+18 year)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability of the coaching programs
timeFrame: 9 weeks after the inclusion of the patient
measure: Actual usage of the coaching programs
timeFrame: During the whole 8-week intervention
measure: Feasibility of the coaching programs
timeFrame: 9 weeks after the inclusion of the patient
measure: Safety of the coaching programs
timeFrame: During the whole 8-week intervention
Secondary outcomes:
measure: Physical activity
timeFrame: 1 whole week after inclusion and 1 whole week after the 8-week intervention
measure: Functional exercise capacity
timeFrame: 1 week before the start of the intervention and immediately after the 8-week intervention
measure: Symptoms
timeFrame: 1 week before the start of the intervention and immediately after the 8-week intervention
measure: Quality of Life - EORTC QLQ-C30-LC13
timeFrame: 1 week before the start of the intervention and immediately after the 8-week intervention
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: REVAL Gebouw A
state: Limburg
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
Study officials:
affiliation: University Hasselt
name: Chris Burtin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Heleen Demeyer, PhD
role: PRINCIPAL_INVESTIGATOR
References: