Early Cognitive Interventions in Digital Format for Cancer Survivors

NCT07729969 | Recruiting

• 2 other identifiers: INCOTEMBIO24/CA/020/BG
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Cognitive Change; Cognitive Impairment; Cancer

Keywords

Cancer Related Cognitive Impairment (CRCI); Digital interventions; Computerized Cognitive Training; Virtual Reality Cognitive Training (VR)

Outcome Measures

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.

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

Secondary Outcomes (23)

• Adherence

  Throughout the 10-week intervention

• Change in Montreal Cognitive Assessment (MoCA) score

  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

  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

  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

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

Study Arms (3)

Computerized cognitive training - BrainHQ

EXPERIMENTAL

The arm will follow the cognitive training program BrainHQ.

Behavioral: Computerized cognitive treatment

Virtual Reality cognitive training - Enhance VR

EXPERIMENTAL

The arm will follow the cognitive training program Enhance VR.

Behavioral: Virtual reality cognitive training

Control Group

NO INTERVENTION

The arm will receive usual care with no cognitive intervention

Interventions

Computerized cognitive treatment BEHAVIORAL

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.

Computerized cognitive training - BrainHQ

Virtual reality cognitive training BEHAVIORAL

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.

Virtual Reality cognitive training - Enhance VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute: lead
• Biobizkaia Health Research Institute: collaborator

Study Sites (3)

Hospital Universitario Basurto

Bilbao, Bizkaia, 48013, Spain

RECRUITING

Hospital Universitario Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Gipuzkoa, 20014, Spain

RECRUITING

Related Publications (16)

• 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.

  PMID: 37012969 BACKGROUND

• Wu 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.

  PMID: 29282534 BACKGROUND

• Von 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.

  PMID: 37039279 BACKGROUND

• Von 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.

  PMID: 35648204 BACKGROUND

• Serweta-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.

  PMID: 36980525 BACKGROUND

• Runowicz 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.

  PMID: 26644543 BACKGROUND

• Mayo 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.

  PMID: 33514444 BACKGROUND

• Lange 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.

  PMID: 30884207 BACKGROUND

• Lange 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.

  PMID: 29232539 BACKGROUND

• Koppelmans 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.

  PMID: 22370315 BACKGROUND

• Joly 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.

  PMID: 26344551 BACKGROUND

• Janelsins 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.

  PMID: 24716504 BACKGROUND

• Hutchinson 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.

  PMID: 22658913 BACKGROUND

• Garcia-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.

  PMID: 36175973 BACKGROUND

• Brugada-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.

  PMID: 35721794 BACKGROUND

• Bray VJ, Dhillon HM, Bell ML, Kabourakis M, Fiero MH, Yip D, Boyle F, Price MA, Vardy JL. Evaluation of a Web-Based Cognitive Rehabilitation Program in Cancer Survivors Reporting Cognitive Symptoms After Chemotherapy. J Clin Oncol. 2017 Jan 10;35(2):217-225. doi: 10.1200/JCO.2016.67.8201. Epub 2016 Oct 28.

  PMID: 28056205 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Neoplasms

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Dr. Ander Urruticoechea Ribate

CONTACT

+34943328000; ander.urruticoechearibate@osakidetza.eus

Dra. Mari Feli González

CONTACT

+34943328380; mariafeliciana.gonzalezperez@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial comparing two cognitive interventions (computerized and virtual reality) and a control group with no cognitive intervention.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: July 28, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)