RecruitingNot ApplicableNCT06027632

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

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


Sponsor

Centre Francois Baclesse

Enrollment

300 participants

Start Date

Feb 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Months

Plain Language Summary

Simplified for easier understanding

This study is testing an online, computer-based brain training program (cognitive stimulation therapy delivered remotely) to help breast cancer survivors who struggle with memory, focus, and thinking after chemotherapy — often called "chemo brain." Participants complete sessions from home using a laptop, making it accessible without hospital visits. **You may be eligible if...** - You have been diagnosed with localized breast cancer - You are 18 or older, completed chemotherapy, and are currently undergoing radiation therapy - You are experiencing cognitive difficulties (memory, concentration) that affect your quality of life - You have access to a laptop with internet and can use it independently - You are fluent in French **You may NOT be eligible if...** - You have a known neurological condition causing cognitive problems (e.g., prior stroke, dementia, epilepsy) - You have a serious ongoing psychiatric disorder (e.g., schizophrenia) - You have major hearing or vision impairment - You are already participating in a cognitive training program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(25)

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

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NCT06027632


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