Brain Tumor Adult
Conditions
Keywords
Brain Tumor, Adapted physical activity (APA)
Brief summary
The goal of this clinical trial is to assess the feasibility of an adapted physical activity (APA) program in adult patients (≥18 years) with primary brain tumors, regardless of tumor type, grade, treatment stage, or the presence of motor, sensory, attention, concentration, or memory deficits. The main question it aims to answer is: What is the effective adherence rate to an APA program among eligible patients with primary brain tumors? Additional questions include: * What is the observance rate (number of sessions completed, intensity achieved, and duration) during the 3-month supervised APA program? * What is the retention rate (proportion of patients completing the program and continuing APA beyond the initial period)? * What is the impact of APA on quality of life, anxiety-depression, and cancer-related symptoms (measured via QLQ-BN20, HADS, and MFI-20 questionnaires at baseline, 3, and 4 months)? Participants will: * Undergo a 3-month supervised APA program (with possible continuation beyond this period). * Use connected watches to monitor physical activity (if they accept the general conditions of use). * Complete self-questionnaires (IPAQ, BREQ-2, QPP, QLQ-BN20, HADS, MFI-20) at inclusion, 3 months, and 4 months. * Be followed for a total of 4 months after inclusion.
Interventions
OTHERadapted physical activity
Adapted Physical Activity (APA) is a tailored exercise program designed for individuals with specific health conditions, such as brain tumors. It aims to improve physical function, quality of life, and overall well-being while ensuring safety and feasibility. APA is supervised by trained professionals and adapted to each individual's abilities and needs.
Sponsors
Center Eugene Marquis
University of Rennes 2
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women ≥ 18 years old, * Receiving medical oncology treatment at the CLCC Eugène Marquis, * Diagnosed with a primary brain tumour, regardless of diagnosis, grade or treatment, * Possible motor, sensory, attention, concentration, or memory deficits, * Patients who accept the general terms of use for connected watches * Patients affiliated with or covered by the French social security system, * Patients who have received information and signed informed consent (or their legal representative),
Exclusion criteria
* WHO score ≥ 3 * Comprehension disorders that prevent participation in adapted physical activity * Pregnant or breastfeeding women * Patients without the necessary devices to use a smartwatch (smartphone, tablet or computer), * Patients deprived of liberty, under guardianship, or curatorship, or subject to any other administrative safeguard measure. Patients unable to comply with the study schedule for social, medical, or psychological reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective adherence rate to the Adapted Physical Activity program | Baseline to 4 months | The primary outcome is the proportion of eligible patients who participate in at least one Adapted Physical Activity session out of the total number of eligible patients solicited for inclusion. This metric Evaluates the feasibility of Adapted Physical Activity implementation in brain tumor patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adapted Physical Activity program observance rate | Baseline to 4 months | Evaluated through the number of sessions completed, the number of sessions reaching the recommended intensity level, and the duration of sessions performed during the 3-month supervised period and the 1-month autonomous period. |
| Retention rate during the 3-month supervised Adapted Physical Activity period | Baseline to 3 months | Proportion of patients who complete the entire 3-month supervised APA program, reflecting their commitment and ability to sustain participation. |
| Retention Rate After Supervised Adapted Physical Activity Period | 4 months | Proportion of patients who continue Adapted Physical Activity beyond the initial 3-month supervised period, assessed at 4 months. |
| Reasons for early discontinuation of Adapted Physical Activity | Baseline to 4 months | Documentation of specific reasons (e.g., fatigue, disease progression, lack of motivation) for patients who discontinue Adapted Physical Activity prematurely |
| Quality of life assessment using EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20 | Baseline, 3 months, and 4 months | Evaluation of brain tumor-specific quality of life using the EORTC Quality of Life Questionnaire - Brain Neoplasm Module 20 questionnaire, which assesses symptoms and functional domains relevant to brain tumor patients |
| Anxiety and depression assessment using Hospital Anxiety and Depression Scale questionnaire | Baseline, 3 months, and 4 months | Evaluation of anxiety and depression levels using the Hospital Anxiety and Depression Scale, a validated tool for assessing psychological distress |
| Fatigue assessment using Multidimensional Fatigue Inventory-20 questionnaire | Baseline, 3 months, and 4 months | Evaluation of multidimensional fatigue (general, physical, mental, reduced motivation, and reduced activity) using the Multidimensional Fatigue Inventory-20 questionnaire |
| Physical activity level assessment using International Physical Activity Questionnaire | Baseline, 3 months, and 4 months | Evaluation of physical activity intensity and frequency using the International Physical Activity Questionnaire, which classifies participants into low, moderate, or high activity levels |
| Motivation for physical activity assessment using Behavioral Regulation in Exercise Questionnaire - Version 2 | Baseline, 3 months, and 4 months | Evaluation of motivation types (intrinsic, identified, introjected, external) using the Behavioral Regulation in Exercise Questionnaire - Version 2 |
| Perceived enjoyment of physical activity assessment using Physical Activity Enjoyment Scale questionnaire | Baseline, 3 months, and 4 months | Evaluation of enjoyment and satisfaction related to physical activity using the Physical Activity Enjoyment Scale questionnaire |
Countries
France
Contacts
CONTACTValérie JOLAINE
PRINCIPAL_INVESTIGATORElodie VAULEON, Dr
Centre de lutte contre le cancer Eugène Marquis
Outcome results
None listed