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NCT07429487
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
Conditions: Breast Cancer, Colorectal Cancer, Ovarian Adenocarcinoma, Pancreatic Cancer, Gastric Adenocarcinoma
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 98
Sponsor: Centre Antoine Lacassagne
Location: Centre Antoine Lacassagne Nice
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 Criteria
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
Source: ClinicalTrials.gov (NCT07429487). StuddyBuddy aggregates publicly available trial information.