Multimodal Web-Based Intervention for Cancer-Related Cognitive Impairment in Breast Cancer Patients: Cog-Stim Feasibility Study Protocol
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study design
2.2. Objectives
2.2.1. Primary Outcome
2.2.2. Secondary Outcomes
- (1)
- To evaluate the proportion of acceptance (attrition) of the study among breast cancer patients starting adjuvant radiotherapy, and according to previous adjuvant chemotherapy. The number of patients contacted, program rejection and acceptance rates, as well as reasons for rejection will be recorded, along with the presence or absence of prior chemotherapy treatment.
- (2)
- To evaluate patients’ satisfaction regarding the proposed intervention program (frequency, duration, content of the sessions, whether the moment to initiate cognitive rehabilitation throughout the oncologic management is appropriate, obstacles to access and use the different software, and the perceived usefulness of the program). This information will be collected using a 13-item questionnaire, developed in our institution for this study.
- (3)
- To identify barriers to accessing the program (impossibility or inability to use the computer, no access to internet connections etc.) or to achieve its completion (motives of non-eligibility, non-participation, and drop-out, etc.). This information will be collected and stored by the neuropsychologist throughout the research program;
- (4)
- To evaluate exercise intensity and training burden and its possible impact on adherence to the protocol. This information will be collected by the APA specialist and stored on the Mooven App.
2.3. Participants: Recruitment and Procedure
2.4. Inclusion Criteria
2.5. Assessments
- Verbal Memory (VBM), which investigates word recognition and words memorization ability (immediate and delayed recall);
- Visual Memory (VIM), which investigates recognition and memorization of geometric shapes (immediate and delayed recall);
- Finger Tapping (FTT), for motor speed and fine motor control assessment;
- Symbol Digit (SDC) to investigate information processing speed, complex attention, visual-perceptual speed and complex information processing speed-accuracy;
- Stroop test (ST) for simple and complex reaction time, inhibition/disinhibition abilities, processing speed and frontal or executive skills assessment;
- Shifting Attention (SAT) to assess executive functions, decision making and reaction time;
- Continuous Performance (CPT) for sustained attention, impulsivity and choice reaction time.
2.6. The Multimodal Web-Based Intervention
2.6.1. Cognitive Stimulation—HappyNeuron Platform®
2.6.2. Adapted Physical Activity Training—Mooven® Platform
2.7. Statistical Analysis
- social barriers (patients living in remote areas with a poor internet connection, patients with limited access to computer material or low skills in informatics, etc., resulting in selection bias of more affluent women and social inequalities in the access to the program),
- technological barriers (patients with limited skills in informatics, inappropriate material),
- or availability barriers (already in an APA or cognitive training program, program too demanding/exhausting, not available enough to complete it, not the good time during cancer therapeutic management to propose cognitive management, etc.).
3. Discussion
4. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Data Collection | Before Inclusion | Baseline Assessment (T0) | Assessment Post-Intervention (T1) |
---|---|---|---|
Signature of Informed Consent | |||
Clinical Examination Including medical history ECOG and vital signs | |||
Cognitive Assessment AND Quality of Life Questionnaires | |||
FACT-COG | |||
MoCA | |||
CNS Vital signs battery | |||
HADS, FACIT-F, ISI | |||
Patient’s Satisfaction |
Cognitive Domains Trained | Exercises |
---|---|
Memory (Verbal and Visual) | Words, Where are you? Elephant Memory Shapes and Colours Heraldry Displaced Characters Displaced Images N-Back Around the World in 80 trips I Remember You! Restaurant An American in Paris Find Your Way! Chunking Objects, Where are You? |
Executive functions | Towers of Hanoi |
Basketball in New-York | |
Hurry for Change! | |
Attention | Pay Attention! |
Private Eye! | |
Sound Check! | |
Ancient Writing | |
Information processing speed | Two-Timing |
Under Pressure | |
Gulf Stream | |
Catch the Ladybug! | |
Language | Split words |
Embroidery | |
Secret files | |
Speak Your Mind! | |
Decipher | |
Writing in the Stars | |
This Story is Full of Blanks! | |
Which One is Alike? | |
Logic | The Right Count |
Countdown | |
Ready, Steady, Count! | |
visuospatial abilities | Sleight of Hands |
Entangled Figures | |
Point of View | |
Turn Around and Around |
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Binarelli, G.; Lange, M.; Dos Santos, M.; Grellard, J.-M.; 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 2021, 13, 4868. https://doi.org/10.3390/cancers13194868
Binarelli G, Lange M, Dos Santos M, Grellard J-M, 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. 2021; 13(19):4868. https://doi.org/10.3390/cancers13194868
Chicago/Turabian StyleBinarelli, Giulia, Marie Lange, Mélanie Dos Santos, Jean-Michel Grellard, Anaïs Lelaidier, Laure Tron, Sophie Lefevre Arbogast, Benedicte Clarisse, and Florence Joly. 2021. "Multimodal Web-Based Intervention for Cancer-Related Cognitive Impairment in Breast Cancer Patients: Cog-Stim Feasibility Study Protocol" Cancers 13, no. 19: 4868. https://doi.org/10.3390/cancers13194868