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Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study (COG-TAB-AGE)

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive stimulation
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Cognition

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with breast cancer, aged 70 and over,
  • During treatment with chemotherapy, targeted therapy or radiotherapy.
  • Whatever the stage of the disease,
  • Hospitalised in a week hospital, in traditional hospitalisation for an intercurrent episode or day hospitalisation, or undergoing radiotherapy
  • Absence of major cognitive impairment preventing cognitive tests (compliance with the MoCA score threshold based on the patient's age and educational level according to GRECOGVASC standards),
  • Patient with education level 3 "end of primary education" minimum (Barbizet scale),
  • Mastery of the French language,
  • Patient who signed the consent to participate in the study.

Exclusion Criteria:

  • Hospitalization for neurological reasons (e.g. confusion), or psychiatric,
  • Documented brain metastases,
  • History of brain radiation therapy,
  • Progressive psychiatric pathology or known dementia,
  • Abuse of alcohol or drug use,
  • Severe visual and / or hearing loss,
  • Patient's refusal to participate,
  • Patient deprived of liberty or under guardianship.

Sites / Locations

  • Centre François Baclesse
  • Centre Henri Becquerel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cognitive stimulation

Arm Description

3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days

Outcomes

Primary Outcome Measures

Acceptance rate
Satisfaction questionnary (Patient satisfaction questionnary; minimum 1 to maximum 5; 8 questions)

Secondary Outcome Measures

Full Information

First Posted
February 6, 2020
Last Updated
July 31, 2023
Sponsor
Centre Francois Baclesse
Collaborators
Centre Henri Becquerel
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1. Study Identification

Unique Protocol Identification Number
NCT04261153
Brief Title
Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study
Acronym
COG-TAB-AGE
Official Title
Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

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

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
Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. These disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. However, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. It is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.Although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. Stimulation programs of this type have been developed in electronic format. However, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.Sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.The HAPPYNeuron® software, developed by a French team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).For this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cognition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive stimulation
Arm Type
Other
Arm Description
3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days
Intervention Type
Other
Intervention Name(s)
Cognitive stimulation
Intervention Description
3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days
Primary Outcome Measure Information:
Title
Acceptance rate
Description
Satisfaction questionnary (Patient satisfaction questionnary; minimum 1 to maximum 5; 8 questions)
Time Frame
between inclusion to 1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with breast cancer, aged 70 and over, During treatment with chemotherapy, targeted therapy or radiotherapy. Whatever the stage of the disease, Hospitalised in a week hospital, in traditional hospitalisation for an intercurrent episode or day hospitalisation, or undergoing radiotherapy Absence of major cognitive impairment preventing cognitive tests (compliance with the MoCA score threshold based on the patient's age and educational level according to GRECOGVASC standards), Patient with education level 3 "end of primary education" minimum (Barbizet scale), Mastery of the French language, Patient who signed the consent to participate in the study. Exclusion Criteria: Hospitalization for neurological reasons (e.g. confusion), or psychiatric, Documented brain metastases, History of brain radiation therapy, Progressive psychiatric pathology or known dementia, Abuse of alcohol or drug use, Severe visual and / or hearing loss, Patient's refusal to participate, Patient deprived of liberty or under guardianship.
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study

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