Cognitive Stimulation and Chemobrain. An Innovative Intervention for Cancer Survivors

Universidad Antonio de Nebrija

Status: Enrolling

Conditions: Breast Cancer; Cognitive Decline

Treatments: Other: Personalized cognitive stimulation; Other: Sham cognitive stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05409248

CSCS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed with breast cancer.
• Having undergone chemotherapy.
• Report objective or subjective complaints of cognitive impairment.

Exclusion criteria

• Metastases or brain tumors.
• Existence of a relevant medical, psychiatric, or neurological disorder.
• Significant visual or motor impairments.
• History of alcohol or drug abuse or dependence.
• Be receiving another cognitive stimulation intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Online games designed to target specific cognitive skills such as attention, perception, or inhibition). Activities' difficulty will be automatically adjusted accordingly to each participant's performance, always demanding a maximum cognitive effort.

Treatment:

Other: Personalized cognitive stimulation

Control Group

Active Comparator group

Description:

Online painting and artistic games designed not to target the specific cognitive skills at test. Activities' duration will match those of the experimental group, and its difficulty will be constant through the intervention.

Treatment:

Other: Sham cognitive stimulation