Adherence to a Remote Physical Activity Program on a Smartwatch and its Effect on Fatigue After Adjuvant Chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, open-label study comparing two parallel groups to see if adherence to an adapted physical activity program impacts fatigue levels 3 months after completing adjuvant chemotherapy for cancer. Participants are adults with non-metastatic breast, colorectal, ovarian, pancreatic, biliary, or gastric adenocarcinoma who recently finished chemotherapy and are medically eligible. The program is monitored remotely via a smartwatch, and the trial stratifies participants before randomization to ensure balanced groups. Outcomes focus on changes in fatigue at the 3-month mark, with safety and adherence data collected alongside. The study aims to identify whether higher engagement with remote physical activity translates into meaningful fatigue reduction in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Antoine Lacassagne
  Nice, France Recruiting

Study contacts

• Study coordinator: Ludovic EVESQUE, Doctor
• Email: ludovic.evesque@nice.unicancer.fr
• Phone: +33 492 03 16 22

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.