Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT06234735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2023-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Activity Behavioral Change Intervention in Lung Cancer
Sponsor:
University Ramon Llull
Organization:
Study Overview
Official Title:
A Personalized Physical Activity Intervention and Behavioral Change in Lung Cancer Patients: RETOS Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETOS
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: