Clinical trial NCT06234735: Physical Activity Behavioral Change Intervention in Lung Cancer
Official title: A Personalized Physical Activity Intervention and Behavioral Change in Lung Cancer Patients: RETOS Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Sedentary Behavior
Fatigue
Keywords: Physical activity
Community
Physiotherapy
Lead sponsor: University Ramon Llull
Sponsor class: OTHER
Collaborators: name: Institut Català d'Oncologia
First posted: 2024-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with lung cancer have poor physical activity and increased sedentary behavior, with the presence of high levels of fatigue.

A randomized controlled trial will be carried out to compare usual care versus a personalized exercise program in the community, in order to explore the changes on physical activity and sedentary behavior and its impact on cancer-related fatigue.

Detailed description: Patients with lung cancer are characterized by having low levels of physical activity (PA) and high sedentary behavior (SB), with direct impact on their quality of life, complications and survival. Previous studies have observed that PA programs have high dropout rates and are not very sustainable over time, making it necessary to incorporate models that consider the preferences and possibilities of patients.

Objectives: To compare the effects on PA levels and SB of a 6-month personalized program vs. conventional care, in community-dwelling lung cancer survivors.

Methods: Controlled and randomized pilot study, with intervention and control group, pilot study. 40 non-small cell lung cancer survivors (18 to 70 years old) will be included. The control group will receive the usual recommendations regarding an active and healthy lifestyle. The intervention group will follow a personalized PA and behavior change program in the community, supervised by a physiotherapist expert in therapeutic exercise.

PA and SB measurements will be carried out using accelerometry and self-reported questionnaires. As secondary variables, functional capacity, lung function, dyspnea and fatigue, as well as quality of life will be measured. A motivational interview will be conducted to personalize the intervention considering clinical characteristics, treatment, motivation and preferences. The intervention will be re-evaluated and adapted monthly, considering the results reported weekly.

Through covariance analysis, the levels of PA and SB, among other factors, measured at the beginning and at the end of the intervention will be evaluated.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of non-small cell lung cancer who are candidates for radical and/or metastatic treatment
* ages between 18 and 70
* ability to answer questionnaires in Spanish
* who have accepted participation and signed the informed consent

Exclusion Criteria:

* participants with a life expectancy of less than 6 months
* patients with levels of physical activity greater than 240 metabolic equivalents (MET) METs/day
* patients who have a contraindication to exercise
* patients with dementia or spatial disorientation or behavioral disorders

Primary outcomes:
measure: Physical Activity
timeFrame: 7 consecutive days, before and after intervention (6 months)
measure: Sedentarism
timeFrame: Before and after intervention (6 months)
Secondary outcomes:
measure: Walking distance
timeFrame: Before and after intervention (6 months)
measure: 1-minute Sit-to-Stand test
timeFrame: Before and after intervention (6 months)
measure: Pulmonary function
timeFrame: Before and after intervention (6 months)
measure: Dyspnea
timeFrame: Before and after intervention (6 months), and once a week during intervention.
measure: Cancer Quality of Life Questionnaire
timeFrame: Before and after intervention (6 months).
measure: Fatigue
timeFrame: Before and after intervention (6 months), and once a week during intervention.
measure: Adherence
timeFrame: Once a week during intervention period (6 months).
measure: IPAQ short form
timeFrame: Before and after intervention (6 months).
measure: Hand grip test
timeFrame: Before and after intervention (6 months).
measure: Calf circumference
timeFrame: Before and after intervention (6 months).
measure: Bioimpedance
timeFrame: Before and after intervention (6 months).
measure: Sleep quality
timeFrame: Before and after intervention (6 months), and once a week during intervention period (6 months).
Other outcomes:
measure: Daily dyspnea
timeFrame: Before and after each physical activity session, minimum 3 sessions per week, during the intervention period (6 months).
measure: Steps per day
timeFrame: Once a week during intervention (6 months)
Locations:
city: Barcelona
country: Spain
facility: Blanquerna Health Science Faculty
Study officials:
affiliation: University Ramon Llull
name: Jordi Teixido, PhD
role: STUDY_CHAIR
References: