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Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer (COG STIM 2)

Primary Purpose

Breast Cancer, Cognitive Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive exercises with supervision
Cognitive exercises without supervision
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Months - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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: I have been upset about these problems; These problems have interfered with my ability to work; These problems have interfered with my ability to do things I enjoy; 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.

Sites / Locations

  • Polyclinique Bordeaux Nord Aquitaine
  • Centre hospitalier de Bligny
  • Centre François Baclesse
  • Centre George François Leclerc
  • Groupe Hospitalier Mutualiste de Grenoble
  • CHU de Limoges
  • Centre Léon Bérard
  • Institut Paoli Calmettes
  • ICM Val d'Aurelle
  • Institut de Cancérologie de Lorraine
  • Centre Antoine Lacassagne
  • CHU de Nimes
  • La Pitié Salpétrière
  • Centre Arrmoricain d'Oncologie
  • Centre Henri Becquerel
  • Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Remotely-supervised online cognitive stimulation intervention

Open access to online home-based cognitive exercises without supervision

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
September 11, 2023
Sponsor
Centre Francois Baclesse
Collaborators
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT06027632
Brief Title
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
March 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cognitive Dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remotely-supervised online cognitive stimulation intervention
Arm Type
Other
Arm Title
Open access to online home-based cognitive exercises without supervision
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Cognitive exercises with supervision
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Cognitive exercises without supervision
Intervention Description
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
Primary Outcome Measure Information:
Title
Average change in the score of the Perceived Cognitive Impairment (PCI) subscale score of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Description
Perceived Cognitive Impairment (PCI) score range 0-72 (The higher the score, the fewer cognitive complaints)
Time Frame
After 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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: I have been upset about these problems; These problems have interfered with my ability to work; These problems have interfered with my ability to do things I enjoy; 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.
Facility Information:
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine DOHOLLOU, MD
First Name & Middle Initial & Last Name & Degree
Nadine DOHOLLOU, MD
Facility Name
Centre hospitalier de Bligny
City
Briis-sous-Forges
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste MERIC, MD
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste MERIC, MD
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence JOLY, PhD
Phone
+33 2 31 45 50 50
Email
f.joly@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel GRELLARD
Phone
+33 2 31 45 50 50
Email
jm.grellard@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Florence JOLY, PhD
Facility Name
Centre George François Leclerc
City
Dijon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier MAYEUR, MD
First Name & Middle Initial & Last Name & Degree
Didier MAYEUR, MD
Facility Name
Groupe Hospitalier Mutualiste de Grenoble
City
Grenoble
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia DIAZ, MD
First Name & Middle Initial & Last Name & Degree
Olivia DIAZ, MD
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie DELUCHE, MD
First Name & Middle Initial & Last Name & Degree
Elodie DELUCHE, MD
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoite MERY, MD
First Name & Middle Initial & Last Name & Degree
Benoite MERY, MD
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorene SEGUIN, MD
First Name & Middle Initial & Last Name & Degree
Lorene SEGUIN, MD
Facility Name
ICM Val d'Aurelle
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle GUERDOUX
First Name & Middle Initial & Last Name & Degree
Estelle GUERDOUX
Facility Name
Institut de Cancérologie de Lorraine
City
Nancy
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille SIMON, MD
First Name & Middle Initial & Last Name & Degree
Camille SIMON, MD
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves BONDIAU, PhD
First Name & Middle Initial & Last Name & Degree
Pierre-Yves BONDIAU, PhD
Facility Name
CHU de Nimes
City
Nimes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic FITENI, MD
First Name & Middle Initial & Last Name & Degree
Frederic FITENI, MD
Facility Name
La Pitié Salpétrière
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna WASSERMANN, MD
First Name & Middle Initial & Last Name & Degree
Johanna WASSERMANN, MD
Facility Name
Centre Arrmoricain d'Oncologie
City
Plérin
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme MARTIN-BABAU, MD
First Name & Middle Initial & Last Name & Degree
Jérôme MARTIN-BABAU, MD
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier RIGAL, MD
First Name & Middle Initial & Last Name & Degree
Olivier RIGAL, MD
Facility Name
Gustave Roussy
City
Villejuif
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio DI MEGLIO, MD
First Name & Middle Initial & Last Name & Degree
Antonio DI MEGLIO, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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