Assessment of Adherence to Remotely Monitored Physical Activity Tracked on a Smartwatch, and Its Impact on Reducing Fatigue 3 Months After Adjuvant Chemotherapy for Cancer
Breast CancerColorectal CancerOvarian AdenocarcinomaPancreatic CancerGastric Adenocarcinoma
Investigational drug(s) / intervention(s)
APA program
APA program: patient will benefit of an activity monitored by a wtach and an APA program during 3 months
Study summary
A single-center, randomized (1:1) open-label, prospective, stratified study with two parallel arms, designed to evaluate adherence to the adapted physical activity (APA) program for patients participating in an APA program and to compare changes in fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients aged 18 to 75 years old,
2. Histologically proven non-metastatic adenocarcinoma of breast, colorectal, ovarian, pancreatic, biliary, or gastric origin,
3. Adjuvant chemotherapy completed less than 3 months ago (excluding hormone therapy),
4. PS 0 or 1 according to the World Health Organization (WHO) scale,
5. No recurrence since the end of adjuvant chemotherapy,
6. Patient who has voluntarily agreed to participate in the study and sign the written informed consent form,
7. Patient affiliated with a Social Security scheme.
Exclusion Criteria:
1. New cancer treatment planned (excluding hormone therapy),
2. Patient who has received adjuvant immunotherapy,
3. Cardiological contraindication to the program
4. Decompensated or unstable chronic conditions
5. Severe malnutrition
6. Rheumatological unfitness as determined by the oncologist,
7. Chronic respiratory failure requiring long-term O2 therapy
8. Diabetes with plantar ulceration
9. Progressive or chronic non-healing bedsore/wound
10. Recent unhealed fracture
11. Patient participating in another interventional clinical study at the time of signing the informed consent form.
12. Vulnerable persons as defined in Articles L1121-5 to -8
Primary outcome measure(s)
adherence to the adapted physical activity (APA) program by the percentage of patients who completed 75% of the weekly sessions of the APA program with a heart rate (HR) between 40 and 60% of their reserve HR for 20-40 minutes. — 3 months Assessing adherence to the adapted physical activity (APA) program for patients participating in an APA program
evolution of fatigue in patients who are participating in an APA program by the difference in Multidimensional Fatigue Inventory (MFI-20) questionnaire scores (20 items) between the first and last visit at 3 months. — 3 months Compare the evolution of fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program.
Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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