Lung Cancer Clinical Trial
— RETOSOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Blanquerna Health Science Faculty | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University Ramon Llull | Institut Català d'Oncologia |
Spain,
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). |
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