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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

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.

ClinicalTrials.gov IDNCT07429487

PhaseNA

Enrollment98

SponsorCentre Antoine Lacassagne

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Colorectal Cancer, Ovarian Adenocarcinoma, Pancreatic Cancer, Gastric Adenocarcinoma

About this study

Interventions

Other: APA program — patient will benefit of an activity monitored by a wtach and an APA program during 3 months

Primary outcomes

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)
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)

Eligibility information

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

Study locations

Centre Antoine Lacassagne, Nice, 06100 France

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.