Physical Activity Behavioral Change Intervention in Lung Cancer

Lung Cancer Clinical Trial

— RETOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234735
• Other study ID #: 1399
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2024
• Source: University Ramon Llull
• Contact: Jordi Vilaro, PhD
• Phone: +34 666580946
• Email: jordivc[@]blanquerna.url.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Lung Cancer
• Lung Neoplasms
• Sedentary Behavior

Intervention

Behavioral:
• Physical activity in the community
Supervised and guided PA sessions in the community setting using public resources such as parks, sports facilities, etc.
• Conventional intervention
Conventional protocol for lung cancer and PA recommendations.

Locations

Country	Name	City	State
Spain	Blanquerna Health Science Faculty	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
University Ramon Llull	Institut Català d'Oncologia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Daily dyspnea	During the 6-month intervention period, dyspnea perception will be measured before and immediately after each PA session with the modified Borg scale. This is a 0 to 10 scale, that shows the maximum dyspnea, 10, and 0 no dyspnea at all.	Before and after each physical activity session, minimum 3 sessions per week, during the intervention period (6 months).
Other	Steps per day	During the 6-month intervention period, number of daily steps measured with App pedometer will be registered.	Once a week during intervention (6 months)
Primary	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)
Primary	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	Walking distance	The six-minute walking test (6MWT) will be used to determine walking distance, in meters (m), covered during six minutes. A 30-meter indoor corridor will be used and patients will be encouraged to walk as much as possible during that time.	Before and after intervention (6 months)
Secondary	1-minute Sit-to-Stand test	Number of sit-to- stand repetitions done in 1 minute (STS-1m). A 46-cm high chair will be used.	Before and after intervention (6 months)
Secondary	Pulmonary function	Forced spirometry following the American Thoracic Society (ATS) and European Respiratory Society (ERS) recommendations. The following variables will be obtained from the spirometry: forced vital capacity (FVC, in percentage (%); forced expiratory volume first second (FEV1), in percentage (%).	Before and after intervention (6 months)
Secondary	Dyspnea	The modified Medical Research Council (mMRC) scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ~100 meters or after a few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.	Before and after intervention (6 months), and once a week during intervention.
Secondary	Cancer Quality of Life Questionnaire	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer Module (EORTC QLQ-LC13) is a quality of life questionnaire specific for cancer. It is designed to measure cancer patients' physical, psychological and social functions. The questionnaire consists of multi-item scales and single items. Items are scored 1 to 4 and a higher score indicates more symptom burden.	Before and after intervention (6 months).
Secondary	Fatigue	The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire specific for cancer patients to assess the intensity and impact of fatigue on daily life in the last 7 days. Respondents use a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Responses are added to create a total score (possible range 0 to 52). Higher scores reflect higher levels of fatigue experimented by the patient.	Before and after intervention (6 months), and once a week during intervention.
Secondary	Adherence	The total number of completed PA sessions followed by patients during the intervention period in relation to the total number of planified sessions.	Once a week during intervention period (6 months).
Secondary	IPAQ short form	The International Physical Activity Questionnaire (IPAQ), will provide the subjective perception of time spent in different levels of PA. It is calculated in metabolic equivalent (MET)-minutes per week, calculated as the MET intensity multiplied by the minutes for each activity over the last 7 days and the time spent sitting. Classified with low (1.6 - <3 METs), moderate (3.0 - <6.0 METs) and vigorous (?6 METs) physical activities.	Before and after intervention (6 months).
Secondary	Hand grip test	The hand grip force will be measured by digital dynamometry. The measure will be in kilograms (kg).	Before and after intervention (6 months).
Secondary	Calf circumference	The calf circumference will be assessed with a measuring tape in centimeters (cm) looking for the maximal perimeter. This measure is to assess the skeletal muscle status.	Before and after intervention (6 months).
Secondary	Bioimpedance	Bioimpedance (BIA) will be used to estimate body fat and muscle mass. Fat free mass (FFM) in percentage (%), fat mas (FM) in percentage (%), total body water (TBW) in percentage (%), and body cell mass (BCM) in percentage (%), will be measured.	Before and after intervention (6 months).
Secondary	Sleep quality	The Pittsburgh sleep quality index (PSQI) assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. The PSQI questions are rated from 0 = no difficulty to 3 = severe difficulty, generating scores that correspond to the domains of the scale. The scores range from 0 to 21 and a score >5 be considered as a significant sleep disturbance.	Before and after intervention (6 months), and once a week during intervention period (6 months).