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Early Cognitive Interventions in Digital Format for Cancer Survivors

Early Cognitive Interventions in Digital Format for Cancer Survivors

Recruiting
18 years and older
All
Phase N/A

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Overview

The aim of this study is to evaluate the usability and effectiveness of two professionally supervised home-based cognitive training interventions as part of an early rehabilitation protocol for cancer-related cognitive impairment.

Participants will be randomized to one of the two intervention arms (computerized cognitive intervention or virtual reality cognitive intervention) or to the control group. Participants of the intervention groups will be assessed before and after the 10 weeks intervention or at equivalent time points for the control group. Comparisons between experimental and control participants, and between the participants in the two intervention arms, will be carried out to see which intervention is most effective and accepted.

Description

One of the adverse effects of cancer and its treatments is cognitive decline, which can affect up to 70% of patients throughout the course of their cancer journey. This decline leads to significant difficulties in resuming professional or social roles, among others, and to a reduced quality of life. Results from previous studies suggest that cognitive intervention can help restore affected functions. Within the framework of this project, two digital cognitive intervention platforms (BrainHQ and Enhance VR) have been selected because they offer advantages that make them viable, accessible and effective, such as: (1) being based on proven psychological paradigms; (2) providing a sufficient variety of exercises and difficulty levels; and (3) the ability to be administered at home. Virtual reality (VR) is demonstrating its potential in the healthcare field because it could help address the limitations of transfer and adherence in some cognitive intervention programs. In general, the virtual reality interventions are more ecological, so it is expected that the results will translate more effectively to the patient's daily activities. On the other hand, the greater immersion provides by VR increases motivation and, therefore, improves adherence to this type of interventions.

BrainHQ program consists of online exercises that target the following functions: attention, processing speed, memory, spatial orientation, interpersonal skills and intelligence. BrainHQ will be compared with the Enhace VR cognitive intervention, a library of 15 cognitive exercises developed in virtual reality to train and monitor specific cognitive functions (memory, attention, task flexibility, information processing, orientation, and problem-solving) and motor control.

The interventions will be implemented after the completion of cancer treatments (1-6 months post-chemotherapy) with the aim of promoting early detection of cognitive impairment and preventing it from becoming chronic over time. This will help patients resume their previous roles quickly and effectively.

The purpose of this randomized controlled trial is to test the usability and effectiveness of two digital cognitive interventions in cancer survivors in comparison with a control group.

The specific objectives are:

1\) To compare the acceptance and adherence of the cognitive interventions. 2) To analyze the preliminary effectiveness of the interventions on patients' cognitive functioning and quality of life at two different time points: 2.A. Upon completion of the interventions 2.B. One year after completion of the interventions

Exploratory objective:

3\) Conduct an exploratory cost study of the interventions compared to CAU (Care as Usual) The study is open to patients over 18 years of age with a cancer diagnosis (stages I-III) and subjective complaints of cognitive functioning related to the cancer diagnosis and/or cancer treatments, who completed chemotherapy treatment between 1 and 6 months prior.

After a first usability session at the hospital where the interventions dynamics are introduced, the interventions will be administered remotely under supervision. A psychologist will maintain weekly contact with the participants to check everything is going well.

Participants will be assessed before the intervention begins (T0) and again 10 weeks after (T1), once the intervention has finished. The follow-up assessment (T2) will take place one year after the intervention ends to examine the sustained effects of the intervention programs.

Improving the quality of life for cancer survivors is a global challenge that this project will help to address. The interventions of this project would help to reduce the time required to successfully resume work, family, and social responsibilities.

Eligibility

Inclusion Criteria:

  • Patients over 18 years of age diagnosed with cancer (stage I-III)
  • Subjective complaints of cognitive functioning related to the diagnosis of cancer and/or cancer treatments
  • Between 1-6 months after completion of chemotherapy treatment
  • To have Wi-Fi and a computer/tablet
  • To sign the informed consent form

Exclusion Criteria:

  • Previous history of cancer diagnosis
  • Anticipated change in cancer treatment/general medical treatment during the intervention period
  • Previous diagnosis of cognitive impairment
  • Diagnosis of other neurological or psychiatric diseases
  • Diagnosis of severe untreated depression
  • History of episodes of vertigo, epilepsy or seizures
  • Currently undergoing or having undergone any other type of intervention aimed at improving cognitive functioning (e.g., CRCI workshops)
  • Severe visual or hearing difficulties that may affect the performance of the intervention exercises
  • Inability to speak, understand, read, and write Spanish correctly
  • Failure to sign the informed consent form

Study details
    Cognitive Impairment
    Cognitive Change
    Cancer

NCT07729969

Biogipuzkoa Health Research Institute

1 August 2026

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