Breast CancerWATCH AND ACTNCT07429487
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 study testing APA program in people with Breast Cancer and Colorectal Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Ovarian Adenocarcinoma
- What is being tested?
- APA program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 15 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Antoine Lacassagne
Nice, 06100
Ludovic EVESQUE, doctor, +33 492 03 16 22, ludovic.evesque@nice.unicancer.fr
Ludovic EVESQUE, doctor
About this study
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.
- Conditions
- Breast Cancer, Colorectal Cancer, Ovarian Adenocarcinoma, Pancreatic Cancer, Gastric Adenocarcinoma
- Being tested
- APA program
- Keywords
- adapted physical activity, fatigue, completed adjuvant systemic chemotherapy for cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APA programOther
patient will benefit of an activity monitored by a wtach and an APA program during 3 months
| Study group | Role | What they receive |
|---|---|---|
| APA | Experimental | participating to an APA program Receives: Other: APA program |
| control arm | No intervention | no APA program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months
Secondary outcomes (8)
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100]
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.
Measured: 3 months
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]
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.
Measured: 6 months
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]
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.
Measured: 12 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
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).
Measured: 3 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
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).
Measured: 6 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
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).
Measured: 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
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.
Measured: 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
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2029 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429487
- Sponsor's protocol ID
- 2024/71
- Other IDs
- 2025-A01857-42
- Acronym
- WATCH AND ACT
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07429487
- Acronym / sponsor ID
- WATCH AND ACT / 2024/71
- Conditions
- Breast Cancer, Colorectal Cancer, Ovarian Adenocarcinoma, Pancreatic Cancer, Gastric Adenocarcinoma
- Keywords
- adapted physical activity, fatigue, completed adjuvant systemic chemotherapy for cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Sep 2029 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APA | Experimental | Other: APA programparticipating to an APA program |
| control arm | No intervention | –no APA program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APA programpatient will benefit of an activity monitored by a wtach and an APA program during 3 months | Other | APA |
Primary outcome
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
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.
8 secondary outcomes
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100]
Time frame: 3 months
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]
Time frame: 6 months
evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100]
Time frame: 12 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
Time frame: 3 months
Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126]
Time frame: 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 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA program in people with Breast Cancer and Colorectal Cancer, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludovic EVESQUE, Doctor (+33 492 03 16 22, ludovic.evesque@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.