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)

February 17, 2026 updated by: Centre Antoine Lacassagne
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nice, France, 06100
        • Centre Antoine Lacassagne
        • Contact:
        • Principal Investigator:
          • Ludovic EVESQUE, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APA
participating to an APA program
Other: APA program
patient will benefit of an activity monitored by a wtach and an APA program during 3 months
No Intervention: control arm
no APA program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 months
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.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100]
Time Frame: 3 months

Compare changes in patients' quality of life following the APA program versus standard follow-up.

QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level.
3 months
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]
Time Frame: 6 months
Compare changes in patients' quality of life following the APA program versus standard follow-up. QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level.
6 months
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]
Time Frame: 12 months

Compare changes in patients' quality of life following the APA program versus standard follow-up.

QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level.
12 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
Time Frame: 3 months

Compare the motivation for physical activity among patients following the APA program compared to standard follow-up.

The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension).
3 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
Time Frame: 6 months

Compare the motivation for physical activity among patients following the APA program compared to standard follow-up.

The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension).
6 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
Time Frame: 12 months

Compare the motivation for physical activity among patients following the APA program compared to standard follow-up.

The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension).
12 months
Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 6 months, in patients who followed the APA program versus standard follow-up
Time Frame: 6 months

Compare the difference in MFI-20 fatigue scores between the first visit and the visits at 6 months.

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.
6 months
Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 12 months, in patients who followed the APA program versus standard follow-up
Time Frame: 12 months

Compare the difference in MFI-20 fatigue scores between the first visit and the visits at 12 months.

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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Antoine Lacassagne

Collaborators

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

September 15, 2029

Study Completion (Estimated)

June 15, 2030

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/71
  • 2025-A01857-42 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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