NCT05409248

Cognitive Stimulation and Chemobrain. An Innovative Intervention for Cancer Survivors

Cognitive Stimulation Intervention Program for Cancer Survivors and Its Benefit on Cognitive Performance and Quality of Life

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Universidad Antonio de Nebrija · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present study aims to establish a non-pharmacological alternative in alleviating cognitive deterioration derived from undergoing chemotherapy treatment. Thus, the effectiveness of a personalized and computerized cognitive stimulation program in breast cancer survivors is assessed.

Detailed description

A phase I/II/III clinical trial is proposed in which the first two phases will serve to evaluate the safety of the intervention and the maximum tolerated time of computerized cognitive training per session in the absence of adverse effects. The third phase will consist of a double-blind randomized controlled trial where the effectiveness of the personalized and self-administered computerized cognitive stimulation program will be evaluated. Phase I. Based on a dose-escalation 3+3 design, experienced fatigue or adverse effects will be measured after succeeding 15 minutes cognitive stimulation training blocks. The training dose will be set to a block before extreme fatigue or notable adverse effect has been reported by two or more participants. A trained psychologist will supervise the process. Phase II. To evaluate the effectiveness of the intervention, 20 participants will undertake an interspersed training day and evaluation day through 15 consecutive days. In this way, a total of 8 evaluation sessions (day 1, 3, 5, 7, 9, 11, 13, and 15) and 7 cognitive stimulation sessions (day 2, 4, 6, 8, 10, 12, and 14) will be carried out. A trained psychologist will supervise every step of the process. Phase III. An 8-week personalized and computerized cognitive stimulation program will be established, where the training time per session will be as determined on phase I. 120 participants will be randomized 1:1 ratio to an intervention or active control group. All participants will undertake a pre and post-test, with a total of 40 training sessions (Monday to Friday) during 8 weeks. Although this phase is set to be an online home-based stage, the responsible psychologist will be monitoring participants' performance and will periodically contact participants via telephone.

Conditions

• Breast Cancer
• Cognitive Decline

Interventions

Type	Name	Description
OTHER	Personalized cognitive stimulation	Online gamified activities designed to stimulate cognitive functions (specifically executive function) will be carried out through a mobile application or web browser. Performance feedback will be shown after each activity.
OTHER	Sham cognitive stimulation	Non-therapeutic online games based on artistic tasks designed to not train the specific cognitive abilities at test. The time of each session will match that of the experimental group. Performance feedback will be shown after each game.

Timeline

• Start date: 2022-06-03
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2022-06-08
• Last updated: 2022-06-08

Locations

1 site across 1 country: Spain