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

Breast Cancer Clinical Trial

— COG STIM 2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06027632
• Other study ID #: 2023-A01134-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: March 2029

Study information

• Verified date: August 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2029
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Months and older

Eligibility

Inclusion Criteria:

• 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 is permitted) until 30 days 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:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cognitive Dysfunction

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Centre hospitalier de Bligny	Briis-sous-Forges
France	Centre François Baclesse	Caen
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	Centre Antoine Lacassagne	Nice
France	CHU de Nimes	Nimes
France	La Pitié Salpétrière	Paris
France	Centre Arrmoricain d'Oncologie	Plérin
France	Centre Henri Becquerel	Rouen
France	Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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