Clinical Trials Directory

Trials / Unknown

UnknownNCT06234735

Physical Activity Behavioral Change Intervention in Lung Cancer

A Personalized Physical Activity Intervention and Behavioral Change in Lung Cancer Patients: RETOS Pilot Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University Ramon Llull · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPhysical activity in the communitySupervised and guided PA sessions in the community setting using public resources such as parks, sports facilities, etc.
BEHAVIORALConventional interventionConventional protocol for lung cancer and PA recommendations.

Timeline

Start date
2024-02-15
Primary completion
2025-05-31
Completion
2025-10-31
First posted
2024-01-31
Last updated
2024-02-09

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06234735. Inclusion in this directory is not an endorsement.