NCT04213365

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Centre Francois Baclesse · Academic / Other
• Sex: Female
• Age: 18 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.	12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.

Timeline

• Start date: 2020-01-24
• Primary completion: 2021-11-02
• Completion: 2022-02-11
• First posted: 2019-12-30
• Last updated: 2022-03-08

Locations

1 site across 1 country: France