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
WATCH AND ACT
2 other identifiers
interventional
98
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jun 2026
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 24, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2030
February 24, 2026
February 1, 2026
3.3 years
February 9, 2026
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Assessing adherence to the adapted physical activity (APA) program for patients participating in an APA program
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.
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.
3 months
Secondary Outcomes (8)
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100]
3 months
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]
6 months
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]
12 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
3 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
6 months
- +3 more secondary outcomes
Study Arms (2)
APA
EXPERIMENTALparticipating to an APA program
control arm
NO INTERVENTIONno APA program
Interventions
patient will benefit of an activity monitored by a wtach and an APA program during 3 months
Eligibility Criteria
You may qualify if:
- Patients aged 18 to 75 years old,
- Histologically proven non-metastatic adenocarcinoma of breast, colorectal, ovarian, pancreatic, biliary, or gastric origin,
- Adjuvant chemotherapy completed less than 3 months ago (excluding hormone therapy),
- PS 0 or 1 according to the World Health Organization (WHO) scale,
- No recurrence since the end of adjuvant chemotherapy,
- Patient who has voluntarily agreed to participate in the study and sign the written informed consent form,
- Patient affiliated with a Social Security scheme.
You may not qualify if:
- New cancer treatment planned (excluding hormone therapy),
- Patient who has received adjuvant immunotherapy,
- Cardiological contraindication to the program
- Decompensated or unstable chronic conditions
- Severe malnutrition
- Rheumatological unfitness as determined by the oncologist,
- Chronic respiratory failure requiring long-term O2 therapy
- Diabetes with plantar ulceration
- Progressive or chronic non-healing bedsore/wound
- Recent unhealed fracture
- Patient participating in another interventional clinical study at the time of signing the informed consent form.
- Vulnerable persons as defined in Articles L1121-5 to -8
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Antoine Lacassagne
Nice, 06100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 24, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
September 15, 2029
Study Completion (Estimated)
June 15, 2030
Last Updated
February 24, 2026
Record last verified: 2026-02