Early Cognitive Interventions in Digital Format for Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiogipuzkoa Health Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Computerized cognitive treatment
BehavioralOnline exercises that target the following functions: attention, processing speed, memory, spatial orientation, interpersonal skills and intelligence. Participants will follow an online cognitive training with the BrainHQ program for 10 weeks. Patients will complete exercises that target attention, executive function, memory and processing speed. They will be asked to train approximately 30 minutes per BrainHQ session, 5 times per week for 10 weeks, a total of 25 hours. Training progresses in an adaptive way, based on the progression of the participant.
Virtual reality cognitive training
BehavioralA 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. Participants will follow a virtual reality cognitive training with the Enhance VR program for 10 weeks. Patients will complete exercises that target attention, executive function, memory and processing speed. Participants will be asked to train approximately 30 minutes per Enhance VR session, 4 times per week for 10 weeks, a total of 20 hours. Training progresses in an adaptive way, based on the progression of the participant.
Treatment groups
110 Participants
are divided into 3 treatment groupsGroup A: Computerized cognitive training - BrainHQExperimental treatment 1 intervention
Group B: Virtual Reality cognitive training - Enhance VRExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Perceived Cognitive Function
Functional Assessment of Cancer Therapy-Cognition, FACT-Cog v3 Self-report questionnaire for cancer patients with cognitive problems consisting of 37 items divided in 4 subscales: Perceived Cognitive Impairment (PCI), Perceived Cognitive Abilities (PCA), Comments From Others (OTH), and Impact on Quality of Life (QoL). The items asked for the past 7 days and are rated on a 5-point Likert scale. Higher scores are indicative of a better cognitive function and QoL.
Time frame
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.Secondary outcomes
1
Adherence
Sufficient adherence is defined by completing at least 70% of the required exercise levels
Time frame
Throughout the 10-week intervention2
Change in Montreal Cognitive Assessment (MoCA) score
MoCA: screening tool aiming to detect cognitive impairment. Total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Time frame
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention3
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) score
The HVLT-R assesses learning and immediate and delayed verbal memory. The number of words remembered ranges from 0 to 36 (immediate memory) and from 0 to 12 (delayed memory). Higher scores, words remembered, are indicative of better memory.
Time frame
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention4
Change in Trail Making Test (TMT) completion time
Consists of two parts, to connect numbers in ascending order and to alternate connecting numbers and letters in ascending order. The final score is the time taken to complete the task. The longer it takes, the poorer the cognitive performance.
Time frame
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Biogipuzkoa Health Research Institute
Lead sponsor
Biobizkaia Health Research Institute
Collaborator
Source ClinicalTrials.gov