Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
NCT ID: NCT06027632
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-02-09
2029-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Remotely-supervised online cognitive stimulation intervention
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
Open access to online home-based cognitive exercises without supervision
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Months
FEMALE
No
Sponsors
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UNICANCER
OTHER
Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Centre hospitalier de Bligny
Briis-sous-Forges, , France
Centre François Baclesse
Caen, , 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
Countries
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Facility Contacts
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Nadine DOHOLLOU, MD
Role: primary
Christine VILLATTE-DE FIGUEIREDO, MD
Role: primary
Didier MAYEUR, MD
Role: primary
Camille SIMON, MD
Role: primary
Leonor DROUIN, MD
Role: primary
Johanna WASSERMANN, MD
Role: primary
Jérôme MARTIN-BABAU, MD
Role: primary
Other Identifiers
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2023-A01134-41
Identifier Type: -
Identifier Source: org_study_id
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