Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol) (COG STIM)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- centre François Baclesse
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
cognitive stimulation and adapted physical activity
Arm Description
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
Outcomes
Primary Outcome Measures
Patient adherence
The proposrtion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity
Secondary Outcome Measures
Proportion of acceptance
Proportion of patient who accept the participation in the study
Patient satisfaction
Satisfaction questionnary (Patient satisfaction questionnary; minimum 1 t maximum 5; 15 questions)
Full Information
NCT ID
NCT04213365
First Posted
December 27, 2019
Last Updated
March 7, 2022
Sponsor
Centre Francois Baclesse
Collaborators
National Cancer Institute, France, Ligue contre le cancer, France
1. Study Identification
Unique Protocol Identification Number
NCT04213365
Brief Title
Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)
Acronym
COG STIM
Official Title
Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
February 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
National Cancer Institute, France, Ligue contre le cancer, France
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive stimulation and adapted physical activity
Arm Type
Other
Arm Description
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
Intervention Type
Other
Intervention Name(s)
Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.
Intervention Description
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
Primary Outcome Measure Information:
Title
Patient adherence
Description
The proposrtion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity
Time Frame
between inclusion and 3 months
Secondary Outcome Measure Information:
Title
Proportion of acceptance
Description
Proportion of patient who accept the participation in the study
Time Frame
Before inclusion
Title
Patient satisfaction
Description
Satisfaction questionnary (Patient satisfaction questionnary; minimum 1 t maximum 5; 15 questions)
Time Frame
between inclusion and 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)
We'll reach out to this number within 24 hrs