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Recruiting NCT07729969

Early Cognitive Interventions in Digital Format for Cancer Survivors

No phase Interventional Cognitive Impairment Cognitive Change Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computerized cognitive treatment, Virtual reality cognitive training.
Who it may be relevant to
Registry conditions: Cognitive Impairment, Cognitive Change, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Early Cognitive Interventions in Digital Format for Cancer Survivors - INCOTEM

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.

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:

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.

Interventions

  • Behavioral Computerized cognitive treatment
    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 a
  • Behavioral Virtual reality cognitive training
    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

Primary outcome measures

  • 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.]
Secondary outcome measures (12)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Spain · 3 centers
  • Hospital Universitario Basurto — Bilbao
  • Hospital Universitario Galdakao-Usansolo — Galdakao
  • Hospital Universitario Donostia — San Sebastián

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. PMID 37012969
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07729969 · INCOTEM · BIO24/CA/020/BG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗