Cognitive ImpairmentINCOTEMNCT07729969
Early Cognitive Interventions in Digital Format for Cancer Survivors
A study testing Computerized cognitive treatment and Virtual reality cognitive training in people with Cognitive Impairment and Cognitive Change, run by Biogipuzkoa Health Research Institute at 3 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Cognitive Change, Cancer
- What is being tested?
- Computerized cognitive treatment and Virtual reality cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesSpain
- Study dates
- 8 Jun 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Basurto
Bilbao, Bizkaia, 48013
Dr. Ander Urruticoechea Ribate, +34943328000, ander.urruticoechearibate@osakidetza.eus
Dra. Mari Feli González, +34943328380, mariafeliciana.gonzalezperez@osakidetza.eus
- Recruiting
Hospital Universitario Galdakao-Usansolo
Galdakao, Bizkaia, 48960
Dr. Ander Urruticoechea Ribate, +34943328000, ander.urruticoechearibate@osakidetza.eus
Dra. Mari Feli González, +34943328380, mariafeliciana.gonzalezperez@osakidetza.eus
- Recruiting
Hospital Universitario Donostia
San Sebastián, Gipuzkoa, 20014
Dr. Ander Urruticoechea Ribate, +34943328000, ander.urruticoechearibate@osakidetza.eus
Dra. Mari Feli González, +34943328380, mariafeliciana.gonzalezperez@osakidetza.eus
About this study
Official title: 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.
Read the detailed 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:
- 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:
- 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.
- Conditions
- Cognitive Impairment, Cognitive Change, Cancer
- Being tested
- Computerized cognitive treatment, Virtual reality cognitive training
- Keywords
- Cancer Related Cognitive Impairment (CRCI), Digital interventions, Computerized Cognitive Training, Virtual Reality Cognitive Training (VR)
- Medical subject headings
- Cognitive Dysfunction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive treatmentBehavioural
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.
Virtual reality cognitive trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Computerized cognitive training - BrainHQ | Experimental | The arm will follow the cognitive training program BrainHQ. Receives: Behavioral: Computerized cognitive treatment |
| Virtual Reality cognitive training - Enhance VR | Experimental | The arm will follow the cognitive training program Enhance VR. Receives: Behavioral: Virtual reality cognitive training |
| Control Group | No intervention | The arm will receive usual care with no cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Secondary outcomes (23)
Adherence
Sufficient adherence is defined by completing at least 70% of the required exercise levels
Measured: Throughout the 10-week intervention
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Measures processing speed. Higher scores, number of correctly correct answers, indicate better processing speed.
Measured: 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)
Cognitive test (higher score indicating better outcome).
Measured: 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)
Cognitive test (higher score indicating better outcome)
Measured: 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)
Cognitive test (higher score indicating better outcome)
Measured: 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)
Cognitive test (higher score indicating better outcome)
Measured: 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)
Cognitive test (higher score indicating better outcome)
Measured: 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)
Cognitive test (higher score indicating better outcome)
Measured: 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
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.
Measured: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Fatigue
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.
Measured: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Sleep Disturbance
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in adherence medication
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.
Measured: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Patient Satisfaction
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.
Measured: Thoughout the 10-week intervention.
Subjective experience with the exercises
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.
Measured: At the usability session.
Usability
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.
Measured: Thoughout the 10-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start8 Jun 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial comparing two cognitive interventions (computerized and virtual reality) and a control group with no cognitive intervention.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Biobizkaia Health Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729969
- Sponsor's protocol ID
- INCOTEM
- Other IDs
- BIO24/CA/020/BG
- Acronym
- INCOTEM
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng Y, Guan Q, Su Y, Huang Q, Zhao J, Wu M, Guo Q, Lyu Q, Zhuang Y, Cheng AS. A self-administered immersive virtual reality tool for assessing cognitive impairment in patients with cancer. Asia Pac J Oncol Nurs. 2023 Feb 28;10(3):100205. doi: 10.1016/j.apjon.2023.100205. eCollection 2023 Mar.
PubMed 37012969Wu LM, Amidi A, Tanenbaum ML, Winkel G, Gordon WA, Hall SJ, Bovbjerg K, Diefenbach MA. Computerized cognitive training in prostate cancer patients on androgen deprivation therapy: a pilot study. Support Care Cancer. 2018 Jun;26(6):1917-1926. doi: 10.1007/s00520-017-4026-8. Epub 2017 Dec 27.
PubMed 29282534Von Ah D, Crouch A, Storey S. Acceptability of computerized cognitive training and global cognitive stimulating-based games delivered remotely: Results from a randomized controlled trial to address cancer and cancer-related cognitive impairment in breast cancer survivors. Cancer Med. 2023 Jun;12(11):12717-12727. doi: 10.1002/cam4.5904. Epub 2023 Apr 11.
PubMed 37039279Von Ah D, McDonald BC, Crouch AD, Ofner S, Perkins S, Storey S, Considine R, Unverzagt F. Randomized double-masked controlled trial of cognitive training in breast cancer survivors: a preliminary study. Support Care Cancer. 2022 Sep;30(9):7457-7467. doi: 10.1007/s00520-022-07182-4. Epub 2022 Jun 1.
PubMed 35648204Serweta-Pawlik A, Lachowicz M, Zurek A, Rosen B, Zurek G. Evaluating the Effectiveness of Visuospatial Memory Stimulation Using Virtual Reality in Head and Neck Cancer Patients-Pilot Study. Cancers (Basel). 2023 Mar 7;15(6):1639. doi: 10.3390/cancers15061639.
PubMed 36980525Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, Cannady RS, Pratt-Chapman ML, Edge SB, Jacobs LA, Hurria A, Marks LB, LaMonte SJ, Warner E, Lyman GH, Ganz PA. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. J Clin Oncol. 2016 Feb 20;34(6):611-35. doi: 10.1200/JCO.2015.64.3809. Epub 2015 Dec 7.
PubMed 26644543Mayo SJ, Rourke SB, Atenafu EG, Vitorino R, Chen C, Kuruvilla J. Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. Pilot Feasibility Stud. 2021 Jan 30;7(1):36. doi: 10.1186/s40814-021-00778-3.
PubMed 33514444Lange M, Licaj I, Clarisse B, Humbert X, Grellard JM, Tron L, Joly F. Cognitive complaints in cancer survivors and expectations for support: Results from a web-based survey. Cancer Med. 2019 May;8(5):2654-2663. doi: 10.1002/cam4.2069. Epub 2019 Mar 18.
PubMed 30884207Lange M, Joly F. How to Identify and Manage Cognitive Dysfunction After Breast Cancer Treatment. J Oncol Pract. 2017 Dec;13(12):784-790. doi: 10.1200/JOP.2017.026286.
PubMed 29232539Koppelmans V, Breteler MM, Boogerd W, Seynaeve C, Gundy C, Schagen SB. Neuropsychological performance in survivors of breast cancer more than 20 years after adjuvant chemotherapy. J Clin Oncol. 2012 Apr 1;30(10):1080-6. doi: 10.1200/JCO.2011.37.0189. Epub 2012 Feb 27.
PubMed 22370315Joly F, Giffard B, Rigal O, De Ruiter MB, Small BJ, Dubois M, LeFel J, Schagen SB, Ahles TA, Wefel JS, Vardy JL, Pancre V, Lange M, Castel H. Impact of Cancer and Its Treatments on Cognitive Function: Advances in Research From the Paris International Cognition and Cancer Task Force Symposium and Update Since 2012. J Pain Symptom Manage. 2015 Dec;50(6):830-41. doi: 10.1016/j.jpainsymman.2015.06.019. Epub 2015 Sep 5.
PubMed 26344551Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
PubMed 24716504Hutchinson AD, Hosking JR, Kichenadasse G, Mattiske JK, Wilson C. Objective and subjective cognitive impairment following chemotherapy for cancer: a systematic review. Cancer Treat Rev. 2012 Nov;38(7):926-34. doi: 10.1016/j.ctrv.2012.05.002. Epub 2012 Jun 2.
PubMed 22658913Garcia-Torres F, Tejero-Perea A, Gomez-Solis A, Castillo-Mayen R, Jaen-Moreno MJ, Luque B, Galvez-Lara M, Sanchez-Raya A, Jablonski M, Rodriguez-Alonso B, Aranda E. Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial. Trials. 2022 Sep 30;23(1):819. doi: 10.1186/s13063-022-06731-w.
PubMed 36175973Brugada-Ramentol V, Bozorgzadeh A, Jalali H. Enhance VR: A Multisensory Approach to Cognitive Training and Monitoring. Front Digit Health. 2022 Jun 3;4:916052. doi: 10.3389/fdgth.2022.916052. eCollection 2022.
PubMed 35721794
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Cognitive Interventions in Digital Format for Cancer Survivors - INCOTEM
- ClinicalTrials.gov ID
- NCT07729969
- Acronym / sponsor ID
- INCOTEM / INCOTEM
- Conditions
- Cognitive Impairment, Cognitive Change, Cancer
- Keywords
- Cancer Related Cognitive Impairment (CRCI), Digital interventions, Computerized Cognitive Training, Virtual Reality Cognitive Training (VR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Collaborators
- Biobizkaia Health Research Institute
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized controlled trial comparing two cognitive interventions (computerized and virtual reality) and a control group with no cognitive intervention.
| Arm | Type | Receives |
|---|---|---|
| Computerized cognitive training - BrainHQ | Experimental | Behavioral: Computerized cognitive treatmentThe arm will follow the cognitive training program BrainHQ. |
| Virtual Reality cognitive training - Enhance VR | Experimental | Behavioral: Virtual reality cognitive trainingThe arm will follow the cognitive training program Enhance VR. |
| Control Group | No intervention | –The arm will receive usual care with no cognitive intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized cognitive treatmentOnline 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. | Behavioural | Computerized cognitive training - BrainHQ |
| Virtual reality cognitive trainingA 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. | Behavioural | Virtual Reality cognitive training - Enhance VR |
Primary outcome
Change in Perceived Cognitive Function
Time frame: 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.
23 secondary outcomes
Adherence
Time frame: Throughout the 10-week intervention
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Fatigue
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in Sleep Disturbance
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Change in adherence medication
Time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.
Patient Satisfaction
Time frame: Thoughout the 10-week intervention.
Subjective experience with the exercises
Time frame: At the usability session.
Usability
Time frame: Thoughout the 10-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 37012969Zeng Y, Guan Q, Su Y, Huang Q, Zhao J, Wu M, Guo Q, Lyu Q, Zhuang Y, Cheng AS. A self-administered immersive virtual reality tool for assessing cognitive impairment in patients with cancer. Asia Pac J Oncol Nurs. 2023 Feb 28;10(3):100205. doi: 10.1016/j.apjon.2023.100205. eCollection 2023 Mar.
- Background: PubMed 29282534Wu LM, Amidi A, Tanenbaum ML, Winkel G, Gordon WA, Hall SJ, Bovbjerg K, Diefenbach MA. Computerized cognitive training in prostate cancer patients on androgen deprivation therapy: a pilot study. Support Care Cancer. 2018 Jun;26(6):1917-1926. doi: 10.1007/s00520-017-4026-8. Epub 2017 Dec 27.
- Background: PubMed 37039279Von Ah D, Crouch A, Storey S. Acceptability of computerized cognitive training and global cognitive stimulating-based games delivered remotely: Results from a randomized controlled trial to address cancer and cancer-related cognitive impairment in breast cancer survivors. Cancer Med. 2023 Jun;12(11):12717-12727. doi: 10.1002/cam4.5904. Epub 2023 Apr 11.
- Background: PubMed 35648204Von Ah D, McDonald BC, Crouch AD, Ofner S, Perkins S, Storey S, Considine R, Unverzagt F. Randomized double-masked controlled trial of cognitive training in breast cancer survivors: a preliminary study. Support Care Cancer. 2022 Sep;30(9):7457-7467. doi: 10.1007/s00520-022-07182-4. Epub 2022 Jun 1.
- Background: PubMed 36980525Serweta-Pawlik A, Lachowicz M, Zurek A, Rosen B, Zurek G. Evaluating the Effectiveness of Visuospatial Memory Stimulation Using Virtual Reality in Head and Neck Cancer Patients-Pilot Study. Cancers (Basel). 2023 Mar 7;15(6):1639. doi: 10.3390/cancers15061639.
- Background: PubMed 26644543Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, Cannady RS, Pratt-Chapman ML, Edge SB, Jacobs LA, Hurria A, Marks LB, LaMonte SJ, Warner E, Lyman GH, Ganz PA. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. J Clin Oncol. 2016 Feb 20;34(6):611-35. doi: 10.1200/JCO.2015.64.3809. Epub 2015 Dec 7.
- Background: PubMed 33514444Mayo SJ, Rourke SB, Atenafu EG, Vitorino R, Chen C, Kuruvilla J. Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. Pilot Feasibility Stud. 2021 Jan 30;7(1):36. doi: 10.1186/s40814-021-00778-3.
- Background: PubMed 30884207Lange M, Licaj I, Clarisse B, Humbert X, Grellard JM, Tron L, Joly F. Cognitive complaints in cancer survivors and expectations for support: Results from a web-based survey. Cancer Med. 2019 May;8(5):2654-2663. doi: 10.1002/cam4.2069. Epub 2019 Mar 18.
- Background: PubMed 29232539Lange M, Joly F. How to Identify and Manage Cognitive Dysfunction After Breast Cancer Treatment. J Oncol Pract. 2017 Dec;13(12):784-790. doi: 10.1200/JOP.2017.026286.
- Background: PubMed 22370315Koppelmans V, Breteler MM, Boogerd W, Seynaeve C, Gundy C, Schagen SB. Neuropsychological performance in survivors of breast cancer more than 20 years after adjuvant chemotherapy. J Clin Oncol. 2012 Apr 1;30(10):1080-6. doi: 10.1200/JCO.2011.37.0189. Epub 2012 Feb 27.
- Background: PubMed 26344551Joly F, Giffard B, Rigal O, De Ruiter MB, Small BJ, Dubois M, LeFel J, Schagen SB, Ahles TA, Wefel JS, Vardy JL, Pancre V, Lange M, Castel H. Impact of Cancer and Its Treatments on Cognitive Function: Advances in Research From the Paris International Cognition and Cancer Task Force Symposium and Update Since 2012. J Pain Symptom Manage. 2015 Dec;50(6):830-41. doi: 10.1016/j.jpainsymman.2015.06.019. Epub 2015 Sep 5.
- Background: PubMed 24716504Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer-related cognitive impairment. Int Rev Psychiatry. 2014 Feb;26(1):102-13. doi: 10.3109/09540261.2013.864260.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive treatment and Virtual reality cognitive training in people with Cognitive Impairment and Cognitive Change, run by Biogipuzkoa Health Research Institute at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ander Urruticoechea Ribate (+34943328000, ander.urruticoechearibate@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Cognitive Function (time frame: Baseline (before randomization and intervention), after completion of the 10-week intervention, and 1 year after completion of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07729969, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.