Physical Activity Behavioral Change Intervention in Lung Cancer

NCT06234735 | Not Yet Recruiting

• 1 other identifier: 1399
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Sedentary Behavior; Fatigue

Keywords

Physical activity; Community; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• Physical Activity

  Level of daily physical activity measured with accelerometry. Accelerometry will be worn by patients for 7 consecutive days and will measure the time in minutes spent in low (1.6 - \<3 METs), moderate (3.0 - \<6.0 METs) and vigorous (⩾6 METs) physical activities.

  7 consecutive days, before and after intervention (6 months)

• Sedentarism

  Weekly sedentary behavior measured with the Sedentary Behaviour Questionnaire (SBQ). The SBQ measures the time in minutes spent in 9 different sedentary activities during a week, differentiating working days and week-ends. The score is the separately sum of the hours per day for week days and week-end days. A higher score is indicative of longer time spent in sitting and therefore an indication of higher sedentarism.

  Before and after intervention (6 months)

Secondary Outcomes (12)

• Walking distance

  Before and after intervention (6 months)

• 1-minute Sit-to-Stand test

  Before and after intervention (6 months)

• Pulmonary function

  Before and after intervention (6 months)

• Dyspnea

  Before and after intervention (6 months), and once a week during intervention.

• Cancer Quality of Life Questionnaire

  Before and after intervention (6 months).

Other Outcomes (2)

• Daily dyspnea

  Before and after each physical activity session, minimum 3 sessions per week, during the intervention period (6 months).

• Steps per day

  Once a week during intervention (6 months)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Conventional intervention

Experimental Group

EXPERIMENTAL

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.

Behavioral: Physical activity in the community

Interventions

Physical activity in the community BEHAVIORAL

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

Experimental Group

Conventional intervention BEHAVIORAL

Conventional protocol for lung cancer and PA recommendations.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ramon Llull: lead
• Institut Català d'Oncologia: collaborator

Study Sites (1)

Blanquerna Health Science Faculty

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Lung Neoplasms; Sedentary Behavior; Fatigue; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jordi Teixido, PhD

  University Ramon Llull

  STUDY CHAIR

Central Study Contacts

Jordi Vilaro, PhD

CONTACT

+34 666580946; jordivc@blanquerna.url.edu

Elena Carrillo, PhD

CONTACT

+32 2533256; elenaca@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator and the professional who will do the statistical analyses, will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: January 31, 2024
• Study Start: February 15, 2024
• Primary Completion: May 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)