Actively Recruiting

Phase Not Applicable
Age: 18Months +
FEMALE
NCT06027632

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

Age: 18Months +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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