Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
COG STIM 2
1 other identifier
interventional
300
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Feb 2024
Longer than P75 for not_applicable breast-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedStudy Start
First participant enrolled
February 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
September 19, 2025
April 1, 2025
4.3 years
August 31, 2023
September 16, 2025
Conditions
Outcome Measures
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)
After 12 weeks
Study Arms (2)
Remotely-supervised online cognitive stimulation intervention
OTHEROpen access to online home-based cognitive exercises without supervision
OTHERInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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;
- 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,
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- UNICANCERcollaborator
Study Sites (25)
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Centre hospitalier de Bligny
Briis-sous-Forges, France
Centre François Baclesse
Caen, 14000, France
CH Métropole Savoie
Chambéry, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre George François Leclerc
Dijon, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
CHU de Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
ICM Val d'Aurelle
Montpellier, France
Institut de Cancérologie de Lorraine
Nancy, France
Hôpital privé du Confluent
Nantes, France
Centre Antoine Lacassagne
Nice, France
Clinique Haute Energie
Nice, France
CHU de Nimes
Nîmes, France
Hôpital Saint-Louis
Paris, France
La Pitié Salpétrière
Paris, France
Centre hospitalier de Pau
Pau, France
Centre Arrmoricain d'Oncologie
Plérin, France
Centre Eugène Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
Clinique Mathilde
Rouen, France
Clinique Medico-chirurgicale Charcot
Sainte-Foy-lès-Lyon, France
Gustave Roussy
Villejuif, France
Related Publications (1)
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.
PMID: 41231878DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 7, 2023
Study Start
February 9, 2024
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
September 19, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share