Physical Activity Behavioral Change Intervention in Lung Cancer

NCT ID: NCT06234735

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2025-10-31

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.

Conditions

Lung Cancer; Sedentary Behavior; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

The control group will follow the conventional protocol established by the Catalan Institute of Oncology (ICO) for the treatment of lung cancer. In addition, physical activity guidelines will be recommended with the aim of encouraging patients to lead a more active life that helps them improve their physical capabilities. The research team will meet individually with participants in the control group and inform them about the importance of physical activity, motivating them to practice regularly.

Group Type: ACTIVE_COMPARATOR

Conventional intervention

Intervention Type: BEHAVIORAL

Conventional protocol for lung cancer and PA recommendations.

Experimental Group

Motivational interviews will be used to help identify individual motivations, barriers, and preferences towards physical activity (PA). Objectives and personalized exercise regimens (e.g. walking, cycling, nordic walking) with a person-centered approach. Patients will engage in a minimum of 3 PA sessions/week (45min each) for 6 months, reporting via a phone app. Weekly patient-reported outcome measures (PROMs) will track progress. The first 3 months involve group sessions for instruction and correction; the last 3 months include one monthly in-person session combining resistance and aerobic training, with a duration of 1.5 hours. To drive behavior change, personalized weekly challenges will be presented.

Group Type: EXPERIMENTAL

Physical activity in the community

Intervention Type: BEHAVIORAL

Supervised and guided PA sessions in the community setting using public resources such as parks, sports facilities, etc.

Interventions

Physical activity in the community

Supervised and guided PA sessions in the community setting using public resources such as parks, sports facilities, etc.

Intervention Type: BEHAVIORAL

Conventional intervention

Conventional protocol for lung cancer and PA recommendations.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Català d'Oncologia

OTHER

Sponsor Role: collaborator

University Ramon Llull

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordi Teixido, PhD

Role: STUDY_CHAIR

University Ramon Llull

Locations

Blanquerna Health Science Faculty

Barcelona, , Spain

Countries

Spain

Central Contacts

Jordi Vilaro, PhD

Role: CONTACT

jordivc@blanquerna.url.edu

+34 666580946

Elena Carrillo, PhD

Role: CONTACT

elenaca@blanquerna.url.edu

+32 2533256

Facility Contacts

Jordi Vilaro, PhD

Role: primary

jordivc@blanquerna.url.edu

+34 666580946

Other Identifiers

1399

Identifier Type: -

Identifier Source: org_study_id