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Breast CancerCOG STIM 2NCT06027632

Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer

A study testing Cognitive exercises with supervision and Cognitive exercises without supervision in people with Breast Cancer and Cognitive Dysfunction, run by Centre Francois Baclesse at 25 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Investigator propose the first French randomized comparative study to assess the efficacy of a remotely supervised online cognitive stimulation program, compared to an unsupervised online cognitive exercise intervention, in reducing cognitive complaints in localized breast cancer patients after adjuvant chemotherapy. Read more about this study

Who is it for?
Ages 18 months and older, women only
Conditions the study is for
Breast Cancer, Cognitive Dysfunction
What is being tested?
Cognitive exercises with supervision and Cognitive exercises without supervision
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
25 sitesFrance
Study dates
9 Feb 2024to Mar 2029
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 months and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient diagnosed with localized breast cancer
  • Age 18 or older,
  • Who have received adjuvant or neo-adjuvant chemotherapy and are currently undergoing adjuvant radiotherapy (ongoing hormone therapy, maintenance therapy other as target therapies or immunotherapy are permitted) until 6 months after end of radiotherapy.
  • Patients who report cognitive complaints that significantly impact their quality of life, as evaluated by the quality of life subscale of the FACT-Cog questionnaire. This subscale is composed by 4 questions:
  • I have been upset about these problems;
  • These problems have interfered with my ability to work;
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  • These problems have interfered with my ability to do things I enjoy;
  • These problems have interfered with the quality of my life.
  • Patients are eligible if their score on this subscale is at or below the 10th percentile, based on age guidelines and normative data (Lange et al., 2015), namely:
  • ≤ 8 for patients aged 30-49 years
  • ≤ 9 for patients aged 50-69 years
  • ≤ 10 for patients aged 70-89 years
  • Patients who have completed at least three years of primary school education, as determined by the Barbizet scale,
  • Patient with access to a functional laptop/computer with a keyboard, internet connection and an e-mail account - being able to use those tools alone,
  • Fluent in French,
  • Patients who have provided informed consent to participate in the study.

Who cannot join

  • Personality disorder or any known progressive psychiatric pathology (e.g. schizophrenia),
  • Previous neurological history with ongoing cognitive symptoms (sequelae of head trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.),
  • Excessive alcohol intake or drug use, which could compromise participation to the intervention
  • Major visual and/or hearing deficit,
  • Patient who might not be able to complete neuropsychological testing, (including those with significant cognitive disorders that impede the completion of cognition tests, as determined by the cognitive screening test MoCA (MONTREAL COGNITIVE ASSESSMENT) and based on age and educational level according to GRECOGVASC (Reflection Group for Vascular COGnitive Assessment) normative data)
  • Already participating in a cognitive training program,
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  • Refusal to participate,
  • Patient deprived of liberty or under guardianship,
  • Patient who might not be able to participate due to geographic, social or psychopathological reasons.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

25 sites in 1 country

France25 sites, 25 recruiting

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux

    Nadine DOHOLLOU, MD

    Nadine DOHOLLOU, MD

    Not yet recruiting

  • Centre hospitalier de Bligny

    Briis-sous-Forges

    Jean-Baptiste MERIC, MD, 33686961024, jb.meric@chbligny.fr

    Jean-Baptiste MERIC, MD

    Recruiting

  • Centre François Baclesse

    Caen, 14000

    Florence JOLY, PhD, +33 2 31 45 50 50, f.joly@baclesse.unicancer.fr

    Jean-Michel GRELLARD, +33 2 31 45 50 50, jm.grellard@baclesse.unicancer.fr

    Recruiting

  • CH Métropole Savoie

    Chambéry

    Cécile AGOSTINI, MD, 33479968951, cecile.agostini-esnault@ch-metropole-savoie.fr

    Cécile AGOSTINI, MD

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Christine VILLATTE-DE FIGUEIREDO, MD

    Christine VILLATTE-DE FIGUEIREDO, MD

    Not yet recruiting

  • Centre George François Leclerc

    Dijon

    Didier MAYEUR, MD

    Didier MAYEUR, MD

    Not yet recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble

    Olivia DIAZ, MD, +33476707308, olivia.diaz@avec.fr

    Olivia DIAZ, MD

    Recruiting

  • CHU de Limoges

    Limoges

    Elodie DELUCHE, MD, 33555056100, elise.deluche@chu-limoges.fr

    Elodie DELUCHE, MD

    Recruiting

  • Centre Léon Bérard

    Lyon

    Benoite MERY, MD, 33478782644, benoite.mery@lyon.unicancer.fr

    Benoite MERY, MD

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Lorene SEGUIN, MD, 33491223789 ext. seguinl@ipc.un, seguinl@ipc.unicancer.fr

    Lorene SEGUIN, MD

    Recruiting

  • ICM Val d'Aurelle

    Montpellier

    Estelle GUERDOUX, 33467612468, estelle.guerdoux@icm.unicancer.fr

    Estelle GUERDOUX

    Recruiting

  • Institut de Cancérologie de Lorraine

    Nancy

    Camille SIMON, MD

    Camille SIMON, MD

    Not yet recruiting

  • Hôpital privé du Confluent

    Nantes

    Dorothée CHOCTEAU-BOUJU, MD, 33228272236, dchocteau@vivalto-sante.com

    Dorothée CHOCTEAU-BOUJU, MD

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Flora COURTAULT-DESLANDES, MD, 33492031623, Flora.COURTAULT-DESLANDES@nice.unicancer.fr

    Flora COURTAULT-DESLANDES, MD

    Recruiting

  • Clinique Haute Energie

    Nice

    Nathalie PINTO, MD, 33493538700, nathalie.pinto@che-nice.com

    Nathalie PINTO, MD

    Not yet recruiting

  • CHU de Nimes

    Nîmes

    Frederic FITENI, MD, +33466683301, frederic.fiteni@chu-nimes.fr

    Frederic FITENI, MD

    Recruiting

  • Hôpital Saint-Louis

    Paris

    Leonor DROUIN, MD

    Leonor DROUIN, MD

    Not yet recruiting

  • La Pitié Salpétrière

    Paris

    Johanna WASSERMANN, MD

    Johanna WASSERMANN, MD

    Not yet recruiting

  • Centre hospitalier de Pau

    Pau

    Kevin BOURCIER, MD, 33559726796, kevin.bourcier@ch-pau.fr

    Kevin BOURCIER, MD

    Recruiting

  • Centre Arrmoricain d'Oncologie

    Plérin

    Jérôme MARTIN-BABAU, MD

    Jérôme MARTIN-BABAU, MD

    Not yet recruiting

  • Centre Eugène Marquis

    Rennes

    Claudia LEFEUVRE-PLESSE, MD, 33299254414, c.lefeuvre@rennes.unicancer.fr

    Claudia LEFEUVRE-PLESSE, MD

    Recruiting

  • Centre Henri Becquerel

    Rouen

    Olivier RIGAL, MD, 33232082501, olivier.rigal@chb.unicancer.fr

    Olivier RIGAL, MD

    Recruiting

  • Clinique Mathilde

    Rouen

    Marine CABOURG, MD, 33665418269, mcabourg@vivalto-sante.com

    Marine CABOURG, MD

    Recruiting

  • Clinique Medico-chirurgicale Charcot

    Sainte-Foy-lès-Lyon

    Nicolas CARRABIN, MD, 334 72 32 31 98, docteur.carrabin@gmail.com

    Nicolas CARRABIN, MD

    Not yet recruiting

  • Gustave Roussy

    Villejuif

    Antonio DI MEGLIO, MD, +33142113503, antonio.di-meglio@gustaveroussy.fr

    Antonio DI MEGLIO, MD

    Recruiting

Other trials in France

About this study

Official title: Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer: a Multicenter Randomized Controlled Trial

Investigator propose the first French randomized comparative study to assess the efficacy of a remotely supervised online cognitive stimulation program, compared to an unsupervised online cognitive exercise intervention, in reducing cognitive complaints in localized breast cancer patients after adjuvant chemotherapy. Previous randomized studies have confirmed the effectiveness of online cognitive stimulation programs compared to standard care. The study seeks to determine the added value of remote supervision by a neuropsychologist. The control group will have access to the same online cognitive exercises as the experimental group but without supervision. Investigator has chosen not to include a wait-list group as it would be unethical to deny patients with cognitive complaints the opportunity to participate in an intervention expected to benefit them. The secondary objective is to evaluate the benefit of the supervised digitalized cognitive intervention on objective cognitive impairment.

The research hypothesis is that incorporating personalized remote support with supervision from a neuropsychologist into a digitalized cognitive stimulation program will reinforce the effectiveness of the intervention on cognitive complaints. This will be achieved by improving participation/adherence to the online cognitive stimulation program, as well as through the personalized supervision itself. Investigator believe that the supervision sessions, including educational components, will enable patients to identify their strengths, promote their cognitive awareness, and develop individualized strategies to apply their compensatory abilities in real-life situations. Since cognitive difficulties have multiple underlying causes, reducing these symptoms requires a multifaceted approach. The hypothesis is that combining cognitive training (which increases neuroplasticity and directly targets the cognitive domains affected by cancer and its treatments), with structured supervised educational sessions based on compensatory strategies, will yield better outcomes than online cognitive stimulation alone.

Being tested
Cognitive exercises with supervision, Cognitive exercises without supervision
Medical subject headings
Breast Neoplasms, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive exercises with supervisionOther

    The experimental group will receive a 12-week intervention consisting of three 20-minute online cognitive stimulation sessions per week along with a weekly 30-minute centralized online remote supervision session with a neuropsychologist. Patient will also have access to the "PRESCO" program of the "HAPPYNeuron-Pro" software, which is designed to train up to 12 different cognitive domains, including attention, memory, executive functions and processing speed

  • Cognitive exercises without supervisionOther

    Patient will have access to the program named "PRESCO" of the "HAPPYNeuron-Pro" software, which is designed to train up to 12 different cognitive domains, including attention, memory, executive functions and processing speed

Study groups in NCT06027632
Study groupRoleWhat they receive
Remotely-supervised online cognitive stimulation interventionOtherNot described
Receives: Other: Cognitive exercises with supervision
Open access to online home-based cognitive exercises without supervisionOtherNot described
Receives: Other: Cognitive exercises without supervision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average change in the score of the Perceived Cognitive Impairment (PCI) subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

    Perceived Cognitive Impairment (PCI) score range 0-72 (The higher the score, the fewer cognitive complaints)

    Measured: After 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2023
  2. Study start9 Feb 2024
  3. Primary completionJun 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06027632
Sponsor's protocol ID
2023-A01134-41
Acronym
COG STIM 2
Status last verified
Apr 2025
First submitted
31 Aug 2023
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bousquet M, Lange M, Lequesne J, Durand-Zaleski I, Diaz O, Di Meglio A, Bachelot T, Grellard JM, Clarisse B, Joly F. Remotely supervised online cognitive training to reduce cognitive difficulties following chemotherapy in patients treated for localized breast cancer: Protocol of the Cog-Stim2 multicenter randomized controlled trial. PLoS One. 2025 Nov 13;20(11):e0335124. doi: 10.1371/journal.pone.0335124. eCollection 2025.

    PubMed 41231878

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive exercises with supervision and Cognitive exercises without supervision in people with Breast Cancer and Cognitive Dysfunction, run by Centre Francois Baclesse at 25 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 16 inclusion and 9 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average change in the score of the Perceived Cognitive Impairment (PCI) subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) (time frame: After 12 weeks). 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 NCT06027632, 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 19 Sep 2025.

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