Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol) (COG STIM)
June 29, 2026 updated by: Centre Francois Baclesse
Investigator general objective is therefore to study and compare the benefit of several methods of management of cognitive difficulties reported by patients during treatment for breast cancer, among several treatments, offered independently in patients' homes and supervised from a distance: adapted physical activity only, cognitive stimulation only, and adapted physical activity coupled with cognitive stimulation (during separate sessions).
The study will therefore be the first to include a group benefiting from these two management methods, which will make it possible to assess the individual benefit of cognitive stimulation sessions and adapted physical activity but also the benefit of combined sessions.As this type of combined management has never been the subject of a study, and previous studies relating to a single type of management having raised patient adhesion difficulties, it does not seem certain that this type of care is feasible in practice.
Before studying its effectiveness, it is therefore essential to check the feasibility and acceptability of such a program combining sessions of adapted physical activity and cognitive stimulation sessions.Investigator will therefore first carry out a feasibility study, longitudinal and monocentric, which will assess the adherence of patients treated for breast cancer to the performance of cognitive stimulation sessions coupled with sessions of adapted physical activity.This feasibility study is a key stage of the Cog-Stim protocol because its results will probably highlight the obstacles to the intervention program, which will allow the investigator to propose adjustments to improve the study design for the following stages of the protocol.
(design optimization).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Caen, France, 14076
- Centre Francois Baclesse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient aged over 18,
- Patient with localized breast cancer, starting or receiving adjuvant radiotherapy , having or not receiving previous adjuvant chemotherapy, not yet having started hormone therapy,
- Patient with a cognitive complaint having a significant impact on her quality of life (FACT
- Cog questionnaire, QoL score ≤ percentile 10 by age),
- Absence of major cognitive impairment preventing the performance of cognitive tests (compliance with the MoCA score threshold according to the age and educational level of the patient according to GRECOGVASC standards)
- Absence of personality disorders and known progressive psychiatric pathology (e.g. schizophrenia),
- Absence of symptomatic neurological history (neurological sequelae of a head trauma, stroke with loss of consciousness> 30 min, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.),
- Patient with level of education 3 "end of primary education" minimum (Barbizet scale),
- Have access to a computer (fixed or portable) equipped with a keyboard, a webcam (or the possibility of connecting one), headphones or speakers; have an internet connection and an e-mail account; be able to use these tools and Equipment,
- Mastery of the French language,
- Patient who signed the consent to participate in the study.
- Patients should start the study during radiation therapy.
Exclusion Criteria:
- Abuse of alcohol or drug use,
- Severe visual and / or hearing loss,
- Patient unable to respond to cognitive tests,
- Medical contraindication to the practice of adapted physical activity
- Cognitive management in progress,
- Patient's refusal to participate,
- Patient deprived of liberty or under guardianship,
- Patient unable to submit to study monitoring for geographic, social or psychopathological reasons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: cognitive stimulation and adapted physical activity
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
|
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient adherence
Time Frame: between inclusion and 3 months
|
The proposrtion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity
|
between inclusion and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of acceptance
Time Frame: Before inclusion
|
Proportion of patient who accept the participation in the study
|
Before inclusion
|
|
Patient satisfaction
Time Frame: between inclusion and 3 months
|
Satisfaction questionnary (Patient satisfaction questionnary; minimum 1 t maximum 5; 15 questions)
|
between inclusion and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2020
Primary Completion (Actual)
November 2, 2021
Study Completion (Actual)
February 11, 2022
Study Registration Dates
First Submitted
December 27, 2019
First Submitted That Met QC Criteria
December 27, 2019
First Posted (Actual)
December 30, 2019
Study Record Updates
Last Update Posted (Actual)
July 2, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A02500-57
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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