Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer (COG STIM 2)

September 16, 2025 updated by: Centre Francois Baclesse

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Not yet recruiting
        • Polyclinique Bordeaux Nord Aquitaine
        • Contact:
          • Nadine Dohollou, MD
        • Principal Investigator:
          • Nadine DOHOLLOU, MD
      • Briis-sous-Forges, France
        • Recruiting
        • Centre Hospitalier de Bligny
        • Principal Investigator:
          • Jean-Baptiste MERIC, MD
        • Contact:
      • Caen, France, 14000
      • Chambéry, France
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Centre Jean Perrin
        • Contact:
          • Christine VILLATTE-DE FIGUEIREDO, MD
        • Principal Investigator:
          • Christine VILLATTE-DE FIGUEIREDO, MD
      • Dijon, France
        • Not yet recruiting
        • Centre George François Leclerc
        • Contact:
          • Didier MAYEUR, MD
        • Principal Investigator:
          • Didier MAYEUR, MD
      • Grenoble, France
        • Recruiting
        • Groupe hospitalier mutualiste de Grenoble
        • Principal Investigator:
          • Olivia DIAZ, MD
        • Contact:
      • Limoges, France
        • Recruiting
        • CHU de Limoges
        • Principal Investigator:
          • Elodie DELUCHE, MD
        • Contact:
      • Lyon, France
        • Recruiting
        • Centre Léon Bérard
        • Principal Investigator:
          • Benoite MERY, MD
        • Contact:
      • Marseille, France
        • Recruiting
        • Institut Paoli Calmettes
        • Principal Investigator:
          • Lorene SEGUIN, MD
        • Contact:
      • Montpellier, France
      • Nancy, France
        • Not yet recruiting
        • Institut de Cancerologie de Lorraine
        • Contact:
          • Camille SIMON, MD
        • Principal Investigator:
          • Camille SIMON, MD
      • Nantes, France
        • Recruiting
        • Hôpital Privé du Confluent
        • Principal Investigator:
          • Dorothée CHOCTEAU-BOUJU, MD
        • Contact:
      • Nice, France
      • Nice, France
        • Not yet recruiting
        • Clinique Haute Energie
        • Contact:
        • Principal Investigator:
          • Nathalie PINTO, MD
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes
        • Principal Investigator:
          • Frédéric FITENI, MD
        • Contact:
      • Paris, France
        • Not yet recruiting
        • Hopital Saint-Louis
        • Contact:
          • Leonor DROUIN, MD
        • Principal Investigator:
          • Leonor DROUIN, MD
      • Paris, France
        • Not yet recruiting
        • La Pitié Salpêtrière
        • Contact:
          • Johanna WASSERMANN, MD
        • Principal Investigator:
          • Johanna WASSERMANN, MD
      • Pau, France
        • Recruiting
        • Centre Hospitalier de Pau
        • Principal Investigator:
          • Kévin BOURCIER, MD
        • Contact:
      • Plérin, France
        • Not yet recruiting
        • Centre Arrmoricain d'Oncologie
        • Contact:
          • Jérôme MARTIN-BABAU, MD
        • Principal Investigator:
          • Jerome MARTIN-BABAU, MD
      • Rennes, France
        • Recruiting
        • Centre Eugene Marquis
        • Principal Investigator:
          • Claudia LEFEUVRE-PLESSE, MD
        • Contact:
      • Rouen, France
        • Recruiting
        • Centre Henri Becquerel
        • Principal Investigator:
          • Olivier RIGAL, MD
        • Contact:
      • Rouen, France
        • Recruiting
        • Clinique Mathilde
        • Principal Investigator:
          • Marine CABOURG, MD
        • Contact:
      • Sainte-Foy-lès-Lyon, France
        • Not yet recruiting
        • Clinique Médico-chirurgicale CHARCOT
        • Principal Investigator:
          • Nicolas Carrabin, MD
        • Contact:
      • Villejuif, France
        • Recruiting
        • Gustave Roussy
        • Principal Investigator:
          • Antonio DI MEGLIO, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Remotely-supervised online cognitive stimulation intervention
Other: Cognitive 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
Other: Open access to online home-based cognitive exercises without supervision
Other: Cognitive 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Perceived Cognitive Impairment (PCI) score range 0-72 (The higher the score, the fewer cognitive complaints)
After 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

UNICANCER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01134-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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