Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study
COG-TAB-AGE
1 other identifier
interventional
55
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jun 2020
Typical duration for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2020
CompletedFirst Posted
Study publicly available on registry
February 7, 2020
CompletedStudy Start
First participant enrolled
June 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedAugust 9, 2024
August 1, 2024
1.8 years
February 6, 2020
August 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptance rate
Satisfaction questionnary (Patient satisfaction questionnary; minimum 1 to maximum 5; 8 questions)
between inclusion to 1 week
Study Arms (1)
cognitive stimulation
OTHER3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days
Interventions
3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- Centre Henri Becquerelcollaborator
Study Sites (2)
Centre François Baclesse
Caen, 14076, France
Centre Henri Becquerel
Rouen, France
Related Publications (1)
Binarelli G, Lange M, Santos MD, Duivon M, Capel A, Fernette M, Boue A, Grellard JM, Tron L, Ahmed-Lecheheb D, Clarisse B, Rigal O, Le Fel J, Joly F. Digital cognitive stimulation in elderly breast cancer patients: the Cog-Tab-Age feasibility study. BMC Complement Med Ther. 2024 May 31;24(1):209. doi: 10.1186/s12906-024-04507-0.
PMID: 38822324DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2020
First Posted
February 7, 2020
Study Start
June 5, 2020
Primary Completion
March 8, 2022
Study Completion
May 31, 2024
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share