Lung CancerRETOSNCT06234735
Physical Activity Behavioral Change Intervention in Lung Cancer
A study testing Physical activity in the community and Conventional intervention in people with Lung Cancer and Sedentary Behavior, run by University Ramon Llull at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer, Sedentary Behavior, Fatigue
- What is being tested?
- Physical activity in the community and Conventional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Blanquerna Health Science Faculty
Barcelona, 08025
Jordi Vilaro, PhD, +34 666580946, jordivc@blanquerna.url.edu
Paula Jakszyn, PhD
About this study
Official title: A Personalized Physical Activity Intervention and Behavioral Change in Lung Cancer Patients: RETOS Pilot Study
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.
Read the 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
- Being tested
- Physical activity in the community, Conventional intervention
- Keywords
- Physical activity, Community, Physiotherapy
- Medical subject headings
- Lung Neoplasms, Sedentary Behavior, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity in the communityBehavioural
Supervised and guided PA sessions in the community setting using public resources such as parks, sports facilities, etc.
Conventional interventionBehavioural
Conventional protocol for lung cancer and PA recommendations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physical activity in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and after intervention (6 months)
Secondary outcomes (12)
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.
Measured: Before and after intervention (6 months)
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.
Measured: Before and after intervention (6 months)
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 (%).
Measured: Before and after intervention (6 months)
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.
Measured: Before and after intervention (6 months), and once a week during intervention.
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.
Measured: Before and after intervention (6 months).
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.
Measured: Before and after intervention (6 months), and once a week during intervention.
Adherence
The total number of completed PA sessions followed by patients during the intervention period in relation to the total number of planified sessions.
Measured: Once a week during intervention period (6 months).
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.
Measured: Before and after intervention (6 months).
Hand grip test
The hand grip force will be measured by digital dynamometry. The measure will be in kilograms (kg).
Measured: Before and after intervention (6 months).
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.
Measured: Before and after intervention (6 months).
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.
Measured: Before and after intervention (6 months).
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.
Measured: Before and after intervention (6 months), and once a week during intervention period (6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start15 Feb 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català d'Oncologia
- Responsible party
- Sponsor
- Investigators
- Jordi Teixido, PhD, Study chair, University Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234735
- Sponsor's protocol ID
- 1399
- Acronym
- RETOS
- Status last verified
- Feb 2024
- First submitted
- 8 Sep 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Physical Activity Intervention and Behavioral Change in Lung Cancer Patients: RETOS Pilot Study
- ClinicalTrials.gov ID
- NCT06234735
- Acronym / sponsor ID
- RETOS / 1399
- Conditions
- Lung Cancer, Sedentary Behavior, Fatigue
- Keywords
- Physical activity, Community, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- Collaborators
- Institut Català d'Oncologia
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Conventional interventionThe 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. |
| Experimental Group | Experimental | Behavioral: Physical activity in the communityMotivational 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity in the communitySupervised and guided PA sessions in the community setting using public resources such as parks, sports facilities, etc. | Behavioural | Experimental Group |
| Conventional interventionConventional protocol for lung cancer and PA recommendations. | Behavioural | Control Group |
Primary outcome
Physical Activity
Time frame: 7 consecutive days, before and after intervention (6 months)
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.
Sedentarism
Time frame: Before and after intervention (6 months)
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.
12 secondary outcomes
Walking distance
Time frame: Before and after intervention (6 months)
1-minute Sit-to-Stand test
Time frame: Before and after intervention (6 months)
Pulmonary function
Time frame: Before and after intervention (6 months)
Dyspnea
Time frame: Before and after intervention (6 months), and once a week during intervention.
Cancer Quality of Life Questionnaire
Time frame: Before and after intervention (6 months).
Fatigue
Time frame: Before and after intervention (6 months), and once a week during intervention.
Adherence
Time frame: Once a week during intervention period (6 months).
IPAQ short form
Time frame: Before and after intervention (6 months).
Hand grip test
Time frame: Before and after intervention (6 months).
Calf circumference
Time frame: Before and after intervention (6 months).
Bioimpedance
Time frame: Before and after intervention (6 months).
Sleep quality
Time frame: Before and after intervention (6 months), and once a week during intervention period (6 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Teixido, PhD study chair
University Ramon Llull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in the community and Conventional intervention in people with Lung Cancer and Sedentary Behavior, run by University Ramon Llull at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordi Vilaro, PhD (+34 666580946, jordivc@blanquerna.url.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 7 consecutive days, before and after intervention (6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.