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Early Cognitive Interventions in Digital Format for Cancer Survivors (INCOTEM)

22 lipca 2026 zaktualizowane przez: Biogipuzkoa Health Research Institute

Early Cognitive Interventions in Digital Format for Cancer Survivors - INCOTEM

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

110

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Computerized cognitive training - BrainHQ
The arm will follow the cognitive training program BrainHQ.

Online 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.

Eksperymentalny: Virtual Reality cognitive training - Enhance VR
The arm will follow the cognitive training program Enhance VR.

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.

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.

Brak interwencji: Control Group
The arm will receive usual care with no cognitive intervention

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Perceived Cognitive Function
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.

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.

Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Adherence
Ramy czasowe: Throughout the 10-week intervention
Sufficient adherence is defined by completing at least 70% of the required exercise levels
Throughout the 10-week intervention
Change in Montreal Cognitive Assessment (MoCA) score
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
MoCA: screening tool aiming to detect cognitive impairment. Total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) score
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
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.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
Change in Trail Making Test (TMT) completion time
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
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.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention
Change in Verbal Fluency score
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Consists of phonological fluency (P-M-R) and semantic fluency (animals, fruits and vegetables). Each word correctly given in each category counts as a point. Higher scores mean better verbal fluency.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Digit Span (WAIS-IV) score
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Measures attention (Digits Forward) and working memory (Digits Backward). The participant must repeat a number sequence. Higher scores, total number sequences correctly repeated, indicate better performance.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Symbol Search (WAIS-IV) score
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Measures processing speed. Higher scores, number of correctly correct answers, indicate better processing speed.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in CANTAB Reaction Time (RTI)
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Cognitive test (higher score indicating better outcome).
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in CANTAB Rapid Visual Information Processin (RVP)
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Cognitive test (higher score indicating better outcome)
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in CANTAB Delayed Matching to Sample (DMS)
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Cognitive test (higher score indicating better outcome)
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in CANTAB Paired Associated Matching (PAL)
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Cognitive test (higher score indicating better outcome)
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in CANTAB Spatial Working Memory (SWM)
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Cognitive test (higher score indicating better outcome)
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in CANTAB One Touch Stockings of Cambridge (OTS)
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Cognitive test (higher score indicating better outcome)
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) score
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
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.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Fatigue
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
EORTC - QCL - FA-12, is a 12-item Likert scale. It evaluates the physical, emotional, and cognitive aspects of fatigue and the interference of it with daily activities and social life in the last 7 days. The items range from 1 to 4 with higher values representing higher symptomatology.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Sleep Disturbance
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Insomnia Severity Index - ISI. It consists of 7 questions asking for difficulties of falling asleep, staying asleep, and problems with waking up too early, current sleep patterns and the effects of sleep on quality of life. Higher scores indicate more sleep problems.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Anxiety and Depression symptoms
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Hospital Anxiety and Depression Scale (HADS). It is used to assess anxiety and depression in a hospital setting. This scale consisted of 14 questions, where half of the questions are related to anxiety and the other half to depression. Each item ranges from 0 to 3. Higher scores indicate the presence of anxiety and/or depression.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in overall Quality of Life
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
EORTC QLQ-C-30. This assessment consisted of 30 questions addressing several aspects of quality of life in cancer patients (Functioning scales: physical, emotional, social, cognitive and role; Symptoms scales: fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea symptoms, plus financial difficulties and global health status / quality of life scale). For each scale, scores range from 0 to 100, with higher scores indicating good functioning in the functioning scales and more symptoms burden in the symptoms scales.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Work Ability Index (WAI)
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
The first two items of the WAI scale rated the current work ability on a Likert scale from 1 to 10 and the current work ability with respect to the physical and the mental demands of the work. On both items higher scores reflect better work ability.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in adherence medication
Ramy czasowe: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Morisky Medication Adherence Scale (MMAS-8) (MMAS-8). The scale consists of 8 items. Response choices are "yes" or "no" for items 1-7 and Item 8 has a five-point Likert response scale. Total scores on the MMAS-8 range from 0 to 8, with higher scores meaning higher adherence.
Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Patient Satisfaction
Ramy czasowe: Thoughout the 10-week intervention.
Net Promoter Score (NPS), assesses satisfaction with a specific product or service by asking how likely that person is to recommend it to someone else on a scale of 0 (not at all likely) to 10 (extremely likely). The final score is calculated by dividing the percentage of promoters (those who score 9-10) by the percentage of detractors (those who score 0-6). The NPS range varies between -100 and +100, with a positive score being considered acceptable and the higher the score, the more acceptable it is considered to be. Client Satisfaction Questionnaire (CSQ-8). Likert-based 8-item questionnaire rating overall satisfaction and acceptability. The 8 items are scored on a 4-point scale (total range from 8-32) with higher scores indicating greater acceptability and satisfaction.
Thoughout the 10-week intervention.
Subjective experience with the exercises
Ramy czasowe: At the usability session.
Game Experience Questionnaire (GEQ). The Core Module consists of 33 items which assess game experience on seven components: Immersion, Flow, Competence, Positive and Negative Affect, Tension, and Challenge. Each item is rated from 0 (Not at all) to 4 (Extremely). High score in a concrete dimension means intense experience on that dimension.
At the usability session.
Usability
Ramy czasowe: Thoughout the 10-week intervention.
System Usability Scale (SUS), is a 10-item self-report measure designed for usability assessment. Items are rated on a 5- 8 point Likert scale (1 = strongly disagree, 5 = strongly agree). Total SUS scores have a range of 0 to 100, being higher scores in the SUS indicative of greater usability.
Thoughout the 10-week intervention.

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Sponsor

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

8 czerwca 2026

Zakończenie podstawowe (Szacowany)

30 kwietnia 2028

Ukończenie studiów (Szacowany)

30 kwietnia 2028

Daty rejestracji na studia

Pierwszy przesłany

5 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 lipca 2026

Pierwszy wysłany (Rzeczywisty)

28 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • INCOTEM
  • BIO24/CA/020/BG (Inny identyfikator: Fundación Vasca de Innovación e Investigación Sanitarias)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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