CClinicalTrials.gg
RecruitingNCT06027632COG STIM 2Updated Sep 19, 2025

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

An interventional study of Cognitive exercises with supervision and Cognitive exercises without supervision in Breast Cancer and Cognitive Dysfunction, sponsored by Centre Francois Baclesse. Recruiting at 25 sites in France. Open to female participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Centre Francois Baclesse · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Months and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Breast Cancer
  • Cognitive Dysfunction
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Francois Baclesse is the lead sponsor of 109 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. I have been upset about these problems;
    2. These problems have interfered with my ability to work;
    3. These problems have interfered with my ability to do things I enjoy;
    4. 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.

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Other
    Remotely-supervised online cognitive stimulation intervention

    Other: Cognitive exercises with supervision

  • Other
    Open access to online home-based cognitive exercises without supervision

    Other: Cognitive exercises without supervision

Interventions

  • OtherCognitive exercises with supervision

    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

  • OtherCognitive exercises without supervision

    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

06

What researchers measure

Primary outcomes

  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)

    Time frame: After 12 weeks

07

Study locations

16 of 25 sites recruiting
  • Polyclinique Bordeaux Nord Aquitaine
    Bordeaux, France
    • Nadine DOHOLLOU, MD · Contact
    • Nadine DOHOLLOU, MD · Principal investigator
    Not yet recruiting
  • Centre hospitalier de Bligny
    Briis-sous-Forges, France
    • Jean-Baptiste MERIC, MD · Contact · jb.meric@chbligny.fr · 33686961024
    • Jean-Baptiste MERIC, MD · Principal investigator
    Recruiting
  • Centre François Baclesse
    Caen, 14000, France
    Recruiting
  • CH Métropole Savoie
    Chambéry, France
    Recruiting
  • Centre Jean Perrin
    Clermont-Ferrand, France
    • Christine VILLATTE-DE FIGUEIREDO, MD · Contact
    • Christine VILLATTE-DE FIGUEIREDO, MD · Principal investigator
    Not yet recruiting
  • Centre George François Leclerc
    Dijon, France
    • Didier MAYEUR, MD · Contact
    • Didier MAYEUR, MD · Principal investigator
    Not yet recruiting
  • Groupe Hospitalier Mutualiste de Grenoble
    Grenoble, France
    • Olivia DIAZ, MD · Contact · olivia.diaz@avec.fr · +33476707308
    • Olivia DIAZ, MD · Principal investigator
    Recruiting
  • CHU de Limoges
    Limoges, France
    Recruiting
  • Centre Léon Bérard
    Lyon, France
    Recruiting
  • Institut Paoli Calmettes
    Marseille, France
    Recruiting
  • ICM Val d'Aurelle
    Montpellier, France
    Recruiting
  • Institut de Cancérologie de Lorraine
    Nancy, France
    • Camille SIMON, MD · Contact
    • Camille SIMON, MD · Principal investigator
    Not yet recruiting
  • Hôpital privé du Confluent
    Nantes, France
    • Dorothée CHOCTEAU-BOUJU, MD · Contact · dchocteau@vivalto-sante.com · 33228272236
    • Dorothée CHOCTEAU-BOUJU, MD · Principal investigator
    Recruiting
  • Centre Antoine Lacassagne
    Nice, France
    Recruiting
  • Clinique Haute Energie
    Nice, France
    Not yet recruiting
  • CHU de Nimes
    Nîmes, France
    Recruiting
  • Hôpital Saint-Louis
    Paris, France
    • Leonor DROUIN, MD · Contact
    • Leonor DROUIN, MD · Principal investigator
    Not yet recruiting
  • La Pitié Salpétrière
    Paris, France
    • Johanna WASSERMANN, MD · Contact
    • Johanna WASSERMANN, MD · Principal investigator
    Not yet recruiting
  • Centre hospitalier de Pau
    Pau, France
    Recruiting
  • Centre Arrmoricain d'Oncologie
    Plérin, France
    • Jérôme MARTIN-BABAU, MD · Contact
    • Jérôme MARTIN-BABAU, MD · Principal investigator
    Not yet recruiting
  • Centre Eugène Marquis
    Rennes, France
    Recruiting
  • Centre Henri Becquerel
    Rouen, France
    Recruiting
  • Clinique Mathilde
    Rouen, France
    Recruiting
  • Clinique Medico-chirurgicale Charcot
    Sainte-Foy-lès-Lyon, France
    Not yet recruiting
  • Gustave Roussy
    Villejuif, France
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06027632
Lead sponsor
Centre Francois Baclesse
Collaborators
UNICANCER
Responsible party
Sponsor
First posted
Sep 7, 2023
Start date
Feb 9, 2024
Primary completion
Jun 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Sep 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion