Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)

Breast Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213365
• Other study ID #: 2019-A02500-57
• Status: Completed
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: February 11, 2022

Study information

• Verified date: March 2022
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 11, 2022
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.
12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.

Locations

Country	Name	City	State
France	centre François Baclesse	Caen

Sponsors (3)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Ligue contre le cancer, France, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient adherence	The proposrtion of patients who will realize cognitive stimulation sessions coupled with sessions of adapted physical activity	between inclusion and 3 months
Secondary	Proportion of acceptance	Proportion of patient who accept the participation in the study	Before inclusion
Secondary	Patient satisfaction	Satisfaction questionnary (Patient satisfaction questionnary; minimum 1 t maximum 5; 15 questions)	between inclusion and 3 months