Breast CancerCOG-TAB-AGENCT04261153
Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study
A study testing Cognitive stimulation in people with Breast Cancer, run by Centre Francois Baclesse at 2 sites in France.
Trial summary
Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Jun 2020to 31 May 2024
- 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Patient with breast cancer, aged 70 and over,
- During treatment with chemotherapy, targeted therapy or radiotherapy.
- Whatever the stage of the disease,
- Hospitalised in a week hospital, in traditional hospitalisation for an intercurrent episode or day hospitalisation, or undergoing radiotherapy
- Absence of major cognitive impairment preventing cognitive tests (compliance with the MoCA score threshold based on the patient's age and educational level according to GRECOGVASC standards),
- Patient with education level 3 "end of primary education" minimum (Barbizet scale),
- Mastery of the French language,
- Patient who signed the consent to participate in the study.
Who cannot join
- Hospitalization for neurological reasons (e.g. confusion), or psychiatric,
- Documented brain metastases,
- History of brain radiation therapy,
- Progressive psychiatric pathology or known dementia,
- Abuse of alcohol or drug use,
- Severe visual and / or hearing loss,
- Patient's refusal to participate,
- Patient deprived of liberty or under guardianship.
Trial locations and contacts
2 sites in 1 country.
About this study
Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. These disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. However, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. It is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.Although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. Stimulation programs of this type have been developed in electronic format. However, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.Sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.The HAPPYNeuron® software, developed by a French team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).For this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface.
- Conditions
- Breast Cancer
- Being tested
- Cognitive stimulation
- Keywords
- Cognition
- 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 stimulationOther
3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days
| Study group | Role | What they receive |
|---|---|---|
| cognitive stimulation | Other | 3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days Receives: Other: Cognitive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance Rate
Acceptance was defined as completing at least three exercises during the training time (10 minutes) during one of the two independent training sessions.
Measured: Between inclusion to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start5 Jun 2020
- Primary completion8 Mar 2022
- Study completion31 May 2024
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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Henri Becquerel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261153
- Sponsor's protocol ID
- 2019-A03112-55
- Acronym
- COG-TAB-AGE
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2020
- 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, Lange M, Santos MD, Duivon M, Capel A, Fernette M, Boue A, Grellard JM, Tron L, Ahmed-Lecheheb D, Clarisse B, Rigal O, Le Fel J, Joly F. Digital cognitive stimulation in elderly breast cancer patients: the Cog-Tab-Age feasibility study. BMC Complement Med Ther. 2024 May 31;24(1):209. doi: 10.1186/s12906-024-04507-0.
PubMed 38822324
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
- Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study
- ClinicalTrials.gov ID
- NCT04261153
- Acronym / sponsor ID
- COG-TAB-AGE / 2019-A03112-55
- Conditions
- Breast Cancer
- Keywords
- Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Centre Henri Becquerel
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 7 Feb 2020 (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.
Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. These disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. However, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. It is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.Although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. Stimulation programs of this type have been developed in electronic format. However, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.Sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.The HAPPYNeuron® software, developed by a French team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).For this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface.
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 | Other | Other: Cognitive stimulation3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Patient with breast cancer, aged 70 and over,
- During treatment with chemotherapy, targeted therapy or radiotherapy.
- Whatever the stage of the disease,
- Hospitalised in a week hospital, in traditional hospitalisation for an intercurrent episode or day hospitalisation, or undergoing radiotherapy
- Absence of major cognitive impairment preventing cognitive tests (compliance with the MoCA score threshold based on the patient's age and educational level according to GRECOGVASC standards),
Key exclusion criteria (8 listed)
- Hospitalization for neurological reasons (e.g. confusion), or psychiatric,
- Documented brain metastases,
- History of brain radiation therapy,
- Progressive psychiatric pathology or known dementia,
- Abuse of alcohol or drug use,
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 stimulation3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days | Other | cognitive stimulation |
Primary outcome
Acceptance Rate
Time frame: Between inclusion to 1 week
Acceptance was defined as completing at least three exercises during the training time (10 minutes) during one of the two independent training sessions.
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 38822324Binarelli G, Lange M, Santos MD, Duivon M, Capel A, Fernette M, Boue A, Grellard JM, Tron L, Ahmed-Lecheheb D, Clarisse B, Rigal O, Le Fel J, Joly F. Digital cognitive stimulation in elderly breast cancer patients: the Cog-Tab-Age feasibility study. BMC Complement Med Ther. 2024 May 31;24(1):209. doi: 10.1186/s12906-024-04507-0.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive stimulation in people with Breast Cancer, run by Centre Francois Baclesse at 2 sites 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 8 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 2 sites 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?
Acceptance Rate (time frame: Between inclusion to 1 week). 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 NCT04261153, 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; AzTrials last refreshed its copy on 6 Nov 2026.