Actively Recruiting
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
Led by Centre Francois Baclesse · Updated on 2025-09-19
300
Participants Needed
25
Research Sites
263 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
U
UNICANCER
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient diagnosed with localized breast cancer
- Age 18 years or older
- Received adjuvant or neo-adjuvant chemotherapy and currently undergoing adjuvant radiotherapy
- Ongoing hormone therapy, maintenance therapy, targeted therapies, or immunotherapy permitted until 6 months after radiotherapy
- Reports cognitive complaints significantly impacting quality of life as per FACT-Cog questionnaire scoring at or below 10th percentile for age
- Completed at least three years of primary school education as per Barbizet scale
- Has access to and can use a functional laptop/computer with keyboard, internet connection, and email
- Fluent in French
- Provided informed consent to participate in the study
You will not qualify if you...
- Personality disorder or known progressive psychiatric pathology (e.g. schizophrenia)
- Previous neurological history with ongoing cognitive symptoms (e.g. head trauma sequelae, stroke, multiple sclerosis, epilepsy, neurodegenerative disease)
- Excessive alcohol intake or drug use compromising participation
- Major visual and/or hearing deficits
- Unable to complete neuropsychological testing including significant cognitive disorders per MoCA screening
- Currently participating in a cognitive training program
- Refusal to participate
- Deprived of liberty or under guardianship
- Unable to participate due to geographic, social, or psychopathological reasons
AI-Screening
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Trial Site Locations
Total: 25 locations
1
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Not Yet Recruiting
2
Centre hospitalier de Bligny
Briis-sous-Forges, France
Actively Recruiting
3
Centre François Baclesse
Caen, France, 14000
Actively Recruiting
4
CH Métropole Savoie
Chambéry, France
Actively Recruiting
5
Centre Jean Perrin
Clermont-Ferrand, France
Not Yet Recruiting
6
Centre George François Leclerc
Dijon, France
Not Yet Recruiting
7
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Actively Recruiting
8
CHU de Limoges
Limoges, France
Actively Recruiting
9
Centre Léon Bérard
Lyon, France
Actively Recruiting
10
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
11
ICM Val d'Aurelle
Montpellier, France
Actively Recruiting
12
Institut de Cancérologie de Lorraine
Nancy, France
Not Yet Recruiting
13
Hôpital privé du Confluent
Nantes, France
Actively Recruiting
14
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
15
Clinique Haute Energie
Nice, France
Not Yet Recruiting
16
CHU de Nimes
Nîmes, France
Actively Recruiting
17
Hôpital Saint-Louis
Paris, France
Not Yet Recruiting
18
La Pitié Salpétrière
Paris, France
Not Yet Recruiting
19
Centre hospitalier de Pau
Pau, France
Actively Recruiting
20
Centre Arrmoricain d'Oncologie
Plérin, France
Not Yet Recruiting
21
Centre Eugène Marquis
Rennes, France
Actively Recruiting
22
Centre Henri Becquerel
Rouen, France
Actively Recruiting
23
Clinique Mathilde
Rouen, France
Actively Recruiting
24
Clinique Medico-chirurgicale Charcot
Sainte-Foy-lès-Lyon, France
Not Yet Recruiting
25
Gustave Roussy
Villejuif, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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