Breast CancerCOG STIMNCT04213365
Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)
A study testing Cognitive stimulation sessions coupled with Adapted Physical Activity sessions. in people with Breast Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
Investigator general objective is therefore to study and compare the benefit of several methods of management of cognitive difficulties reported by patients during treatment for breast cancer, among several treatments, offered independently in patients' homes and supervised from a distance: adapted physical activity… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2020to 11 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged over 18,
- Patient with localized breast cancer, starting or receiving adjuvant radiotherapy , having or not receiving previous adjuvant chemotherapy, not yet having started hormone therapy,
- Patient with a cognitive complaint having a significant impact on her quality of life (FACT
- Cog questionnaire, QoL score ≤ percentile 10 by age),
- Absence of major cognitive impairment preventing the performance of cognitive tests (compliance with the MoCA score threshold according to the age and educational level of the patient according to GRECOGVASC standards)
- Absence of personality disorders and known progressive psychiatric pathology (e.g. schizophrenia),
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- Absence of symptomatic neurological history (neurological sequelae of a head trauma, stroke with loss of consciousness> 30 min, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.),
- Patient with level of education 3 "end of primary education" minimum (Barbizet scale),
- Have access to a computer (fixed or portable) equipped with a keyboard, a webcam (or the possibility of connecting one), headphones or speakers; have an internet connection and an e-mail account; be able to use these tools and Equipment,
- Mastery of the French language,
- Patient who signed the consent to participate in the study.
- Patients should start the study during radiation therapy.
Who cannot join
- Abuse of alcohol or drug use,
- Severe visual and / or hearing loss,
- Patient unable to respond to cognitive tests,
- Medical contraindication to the practice of adapted physical activity
- Cognitive management in progress,
- Patient's refusal to participate,
- Patient deprived of liberty or under guardianship,
- Patient unable to submit to study monitoring for geographic, social or psychopathological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Investigator general objective is therefore to study and compare the benefit of several methods of management of cognitive difficulties reported by patients during treatment for breast cancer, among several treatments, offered independently in patients' homes and supervised from a distance: adapted physical activity only, cognitive stimulation only, and adapted physical activity coupled with cognitive stimulation (during separate sessions). The study will therefore be the first to include a group benefiting from these two management methods, which will make it possible to assess the individual benefit of cognitive stimulation sessions and adapted physical activity but also the benefit of combined sessions.As this type of combined management has never been the subject of a study, and previous studies relating to a single type of management having raised patient adhesion difficulties, it does not seem certain that this type of care is feasible in practice. Before studying its effectiveness, it is therefore essential to check the feasibility and acceptability of such a program combining sessions of adapted physical activity and cognitive stimulation sessions.Investigator will therefore first carry out a feasibility study, longitudinal and monocentric, which will assess the adherence of patients treated for breast cancer to the performance of cognitive stimulation sessions coupled with sessions of adapted physical activity.This feasibility study is a key stage of the Cog-Stim protocol because its results will probably highlight the obstacles to the intervention program, which will allow the investigator to propose adjustments to improve the study design for the following stages of the protocol. (design optimization).
- Conditions
- Breast Cancer
- Being tested
- Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.Other
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
| Study group | Role | What they receive |
|---|---|---|
| cognitive stimulation and adapted physical activity | Other | 12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions. Receives: Other: Cognitive stimulation sessions coupled with Adapted Physical Activity sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Adherence
The proportion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity.
A session of either cognitive or physical training was considered performed if at least 70% of the session was completed (≥ 14/20 min of cognitive session, and 20/30 min of APA session). For each week of the intervention, adherence was considered to be achieved if all four planned sessions were completed. High adherence to the 12-week multimodal intervention was defined as completing at least 9 weeks of the program.
Measured: Between inclusion and 3 months
Secondary outcomes (2)
Proportion of Acceptance
Proportion of patient who accept the participation in the study
Measured: Before inclusion
Patient Satisfaction
Satisfaction questionnary (Patient satisfaction questionnaire; range 0:5 by question, 15 questions, total score range : 0-100) - The higher the scores, the better the satisfaction.
Measured: Between inclusion and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start24 Jan 2020
- Primary completion2 Nov 2021
- Study completion11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213365
- Sponsor's protocol ID
- 2019-A02500-57
- Acronym
- COG STIM
- Status last verified
- Jun 2026
- First submitted
- 27 Dec 2019
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Binarelli G, Joly F, Christy F, Clarisse B, Lange M. Digital multimodal intervention for cancer-related cognitive impairment in breast-cancer patients: Cog-Stim feasibility study. BMC Psychiatry. 2025 Mar 17;25(1):249. doi: 10.1186/s12888-025-06630-9.
PubMed 40098149
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)
- ClinicalTrials.gov ID
- NCT04213365
- Acronym / sponsor ID
- COG STIM / 2019-A02500-57
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Ligue contre le cancer, France
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigator general objective is therefore to study and compare the benefit of several methods of management of cognitive difficulties reported by patients during treatment for breast cancer, among several treatments, offered independently in patients' homes and supervised from a distance: adapted physical activity only, cognitive stimulation only, and adapted physical activity coupled with cognitive stimulation (during separate sessions). The study will therefore be the first to include a group benefiting from these two management methods, which will make it possible to assess the individual benefit of cognitive stimulation sessions and adapted physical activity but also the benefit of combined sessions.As this type of combined management has never been the subject of a study, and previous studies relating to a single type of management having raised patient adhesion difficulties, it does not seem certain that this type of care is feasible in practice. Before studying its effectiveness, it is therefore essential to check the feasibility and acceptability of such a program combining sessions of adapted physical activity and cognitive stimulation sessions.Investigator will therefore first carry out a feasibility study, longitudinal and monocentric, which will assess the adherence of patients treated for breast cancer to the performance of cognitive stimulation sessions coupled with sessions of adapted physical activity.This feasibility study is a key stage of the Cog-Stim protocol because its results will probably highlight the obstacles to the intervention program, which will allow the investigator to propose adjustments to improve the study design for the following stages of the protocol. (design optimization).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive stimulation and adapted physical activity | Other | Other: Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient aged over 18,
- Patient with localized breast cancer, starting or receiving adjuvant radiotherapy , having or not receiving previous adjuvant chemotherapy, not yet having started hormone therapy,
- Patient with a cognitive complaint having a significant impact on her quality of life (FACT
- Cog questionnaire, QoL score ≤ percentile 10 by age),
- Absence of major cognitive impairment preventing the performance of cognitive tests (compliance with the MoCA score threshold according to the age and educational level of the patient according to GRECOGVASC standards)
Key exclusion criteria (8 listed)
- Abuse of alcohol or drug use,
- Severe visual and / or hearing loss,
- Patient unable to respond to cognitive tests,
- Medical contraindication to the practice of adapted physical activity
- Cognitive management in progress,
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 |
|---|---|---|
| Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions. | Other | cognitive stimulation and adapted physical activity |
Primary outcome
Patient Adherence
Time frame: Between inclusion and 3 months
The proportion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity. A session of either cognitive or physical training was considered performed if at least 70% of the session was completed (≥ 14/20 min of cognitive session, and 20/30 min of APA session). For each week of the intervention, adherence was considered to be achieved if all four planned sessions were completed. High adherence to the 12-week multimodal intervention was defined as completing at least 9 weeks of the program.
2 secondary outcomes
Proportion of Acceptance
Time frame: Before inclusion
Patient Satisfaction
Time frame: Between inclusion and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40098149Binarelli G, Joly F, Christy F, Clarisse B, Lange M. Digital multimodal intervention for cancer-related cognitive impairment in breast-cancer patients: Cog-Stim feasibility study. BMC Psychiatry. 2025 Mar 17;25(1):249. doi: 10.1186/s12888-025-06630-9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation sessions coupled with Adapted Physical Activity sessions. in people with Breast Cancer, run by Centre Francois Baclesse 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jul 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?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Adherence (time frame: Between inclusion and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04213365, which also lists 1 linked publication.
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 2 Jul 2026.