Cog-Stim faisabilité
Management of cancer treatments-related cognitive difficulties in women treated for breast cancer : a feasibility study
Coordinator: M Lange, M Dos Santos, F Joly
Background:
Cancer treatments can cause cognitive difficulties in breast cancer patients, who repeatedly report important cognitive complaints. Such cognitive difficulties can impair quality of life, self-confidence, or return to work during the post-cancer period. Despite a growing demand from cancer patients, to our knowledge, there are no existing specific guidelines for management of cognitive complaints (that could be generalisable to every cancer care center), not even in supportive care departments. Cognitive training and adapted physical activity (APA), realized with modern and web-based tools such as online platforms, could respond to the growing demand for management from patients.
Objectives :
This feasibility study is a preliminary step in a multicentric randomised controlled study, aiming at identifying the most efficient intervention to manage cognitive complaints in breast cancer patients starting adjuvant radiotherapy, among several management approaches: APA, cognitive training, and both APA combined with cognitive training, realized with web-based tools, at home, with remote supervision.
The objective of this feasibility project is to confirm acceptance and adherence of patients with cognitive complaints to an intervention program of both APA and cognitive training sessions. This type of « combined » intervention has never been studied and probably requires a bigger commitment from patients than a « single » intervention (with either APA or cognitive training), which could result in a higher risk of low adherence to the program than in previous studies. Therefore, it is necessary to implement a feasibility study prior to the randomized study. Secondary objectives of this feasibility study are to evaluate patients’ satisfaction to such intervention program, and to identify possible non-attendance or drop-out, as well as any other limitations to the program in order to make adjustments and improve the study design for the randomized study.
Study methodology :
Interventional, longitudinal, monocentric pilot study. 20 patients included.
Status:
Closed
Sponsors:
INCa (AO RISP amorçage 2018), Prix Rose sur Green 2019, Géfluc Normandie 2019
Publications:
Binarelli G, Lange M, Dos Santos M, Grellard JM, Lelaidier A, Tron L, Lefevre Arbogast S, Clarisse B, Joly F. Multimodal Web-Based Intervention for Cancer-Related Cognitive Impairment in Breast Cancer Patients: Cog-Stim Feasibility Study Protocol. Cancers (Basel). 2021 Sep 28;13(19):4868. doi: 10.3390/cancers13194868. PMID: 34638354; PMCID: PMC8508392.
Binarelli G, Joly F, Tron L, Lefevre Arbogast S, Lange M. Management of Cancer-Related Cognitive Impairment: A Systematic Review of Computerized Cognitive Stimulation and Computerized Physical Activity. Cancers (Basel). 2021 Oct 14;13(20):5161. doi: 10.3390/cancers13205161. PMID: 34680310; PMCID: PMC8534081.