NCT05409248

Brief Summary

The present study aims to establish a non-pharmacological alternative in alleviating cognitive deterioration derived from undergoing chemotherapy treatment. Thus, the effectiveness of a personalized and computerized cognitive stimulation program in breast cancer survivors is assessed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

October 14, 2021

Last Update Submit

June 3, 2022

Conditions

Breast CancerCognitive Decline

Keywords

Breast cancerCancer survivorsChemobrainCognitive stimulationOnline intervention

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in mini-Mental Adjustment to Cancer Scale (mini-MAC) at Week 8

    The mini-MAC is a validated 29-item self-rated questionnaire that examines five cancer-specific coping strategies: fighting spirit, helplessness, anxious preoccupation, cognitive avoidance, and fatalism. Each item is scored using a 4-point Likert scale. Higher scores on each subscale mean greater use of that strategy.

    Baseline and Week 8

  • Change from Baseline in Cognitive Assessment for Chemo Fog Research (CAB-CF) at Week 8

    The CAB-CF is an online neuropsychological assessment battery that evaluates a total of 23 cognitive skills, grouped into 5 cognitive domains (attention, memory, coordination, perception, and reasoning). Each cognitive skill is scored from 0 to 800. The cognitive domain score is calculated by averaging the scores of the cognitive skills that comprise it. Higher scores mean better cognitive performance.

    Baseline and Week 8

  • Change from Baseline in the Functionality Assessment Instrument in Cancer Treatment - Cognitive Function (FACT-COG) at Week 8

    The FACT-COG is a 37 item self-report questionnaire that assesses patients' perception of their cognitive abilities, functionality, and quality of life. Each item is scored using a 5-point Likert scale. Higher scores indicate less perceived cognitive impairment.

    Baseline and Week 8

Secondary Outcomes (5)

  • Change from Baseline in the State-Trait Anxiety Inventory (STAI) at Week 8

    Baseline and Week 8

  • Change from Baseline in the Beck Depression Inventory (BDI-II) at Week 8

    Baseline and Week 8

  • Change from Baseline in the Brief Fatigue Inventory (BFI) at Week 8

    Baseline and Week 8

  • Change from Baseline in the Measuring Quality of Life | The World Health Organization - abridged version (WHOQOL-BREF) at Week 8

    Baseline and Week 8

  • Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 8

    Baseline and Week 8

Study Arms (2)

Experimental Group

EXPERIMENTAL

Online games designed to target specific cognitive skills such as attention, perception, or inhibition). Activities' difficulty will be automatically adjusted accordingly to each participant's performance, always demanding a maximum cognitive effort.

Other: Personalized cognitive stimulation

Control Group

ACTIVE COMPARATOR

Online painting and artistic games designed not to target the specific cognitive skills at test. Activities' duration will match those of the experimental group, and its difficulty will be constant through the intervention.

Other: Sham cognitive stimulation

Interventions

Personalized cognitive stimulationOTHER

Online gamified activities designed to stimulate cognitive functions (specifically executive function) will be carried out through a mobile application or web browser. Performance feedback will be shown after each activity.

Also known as: CogniFit's personalized brain training
Experimental Group
Sham cognitive stimulationOTHER

Non-therapeutic online games based on artistic tasks designed to not train the specific cognitive abilities at test. The time of each session will match that of the experimental group. Performance feedback will be shown after each game.

Control Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince the study population is breast cancer survivors, and considering its epidemiology, investigators will restrict participants to females.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been diagnosed with breast cancer.
  • Having undergone chemotherapy.
  • Report objective or subjective complaints of cognitive impairment.

You may not qualify if:

  • Metastases or brain tumors.
  • Existence of a relevant medical, psychiatric, or neurological disorder.
  • Significant visual or motor impairments.
  • History of alcohol or drug abuse or dependence.
  • Be receiving another cognitive stimulation intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital la Ribera

Alzira, Valencia, 46600, Spain

RECRUITING

Related Publications (13)

  • Ahles TA. Brain vulnerability to chemotherapy toxicities. Psychooncology. 2012 Nov;21(11):1141-8. doi: 10.1002/pon.3196. Epub 2012 Oct 1.

    PMID: 23023994BACKGROUND

  • Asher A, Myers JS. The effect of cancer treatment on cognitive function. Clin Adv Hematol Oncol. 2015 Jul;13(7):441-50.

    PMID: 26353040BACKGROUND

  • Boykoff N, Moieni M, Subramanian SK. Confronting chemobrain: an in-depth look at survivors' reports of impact on work, social networks, and health care response. J Cancer Surviv. 2009 Dec;3(4):223-32. doi: 10.1007/s11764-009-0098-x. Epub 2009 Sep 16.

    PMID: 19760150BACKGROUND

  • 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: 28056205BACKGROUND

  • Pendergrass JC, Targum SD, Harrison JE. Cognitive Impairment Associated with Cancer: A Brief Review. Innov Clin Neurosci. 2018 Feb 1;15(1-2):36-44.

    PMID: 29497579BACKGROUND

  • Fernandes HA, Richard NM, Edelstein K. Cognitive rehabilitation for cancer-related cognitive dysfunction: a systematic review. Support Care Cancer. 2019 Sep;27(9):3253-3279. doi: 10.1007/s00520-019-04866-2. Epub 2019 May 30.

    PMID: 31147780BACKGROUND

  • Hardy SJ, Krull KR, Wefel JS, Janelsins M. Cognitive Changes in Cancer Survivors. Am Soc Clin Oncol Educ Book. 2018 May 23;38:795-806. doi: 10.1200/EDBK_201179.

    PMID: 30231372BACKGROUND

  • 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: 22658913BACKGROUND

  • Janelsins MC, Heckler CE, Peppone LJ, Kamen C, Mustian KM, Mohile SG, Magnuson A, Kleckner IR, Guido JJ, Young KL, Conlin AK, Weiselberg LR, Mitchell JW, Ambrosone CA, Ahles TA, Morrow GR. Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. J Clin Oncol. 2017 Feb 10;35(5):506-514. doi: 10.1200/JCO.2016.68.5826. Epub 2016 Dec 28.

    PMID: 28029304BACKGROUND

  • Bail J, Meneses K. Computer-Based Cognitive Training for Chemotherapy-Related Cognitive Impairment in Breast Cancer Survivors. Clin J Oncol Nurs. 2016 Oct 1;20(5):504-9. doi: 10.1188/16.CJON.504-509.

    PMID: 27668370BACKGROUND

  • Van Dyk K, Bower JE, Crespi CM, Petersen L, Ganz PA. Cognitive function following breast cancer treatment and associations with concurrent symptoms. NPJ Breast Cancer. 2018 Aug 17;4:25. doi: 10.1038/s41523-018-0076-4. eCollection 2018.

    PMID: 30131974BACKGROUND

  • Von Ah D, Habermann B, Carpenter JS, Schneider BL. Impact of perceived cognitive impairment in breast cancer survivors. Eur J Oncol Nurs. 2013 Apr;17(2):236-41. doi: 10.1016/j.ejon.2012.06.002. Epub 2012 Aug 14.

    PMID: 22901546BACKGROUND

  • Zeng Y, Dong J, Huang M, Zhang JE, Zhang X, Xie M, Wefel JS. Nonpharmacological interventions for cancer-related cognitive impairment in adult cancer patients: A network meta-analysis. Int J Nurs Stud. 2020 Apr;104:103514. doi: 10.1016/j.ijnurstu.2019.103514. Epub 2020 Jan 3.

    PMID: 32004776BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsCognitive DysfunctionChemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCognition DisordersNeurocognitive DisordersMental DisordersDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Jon A Duñabeitia

    Universidad Nebrija

    STUDY DIRECTOR

  • Jose L Tapia

    Univerisdad Nebrija

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon A Duñabeitia

CONTACT

0034634423742jdunabeitia@nebrija.es

Jose L Tapia

CONTACT

0034661157598jtapia@nebrija.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The intervention platform will randomly assign participants in a 1:1 ratio to one out of two groups (control/experimental), so both participants and researchers are blinded. Activities presented to the experimental group will target specific cognitive domains (mainly executive functions) and will be automatically adjusted in difficulty and requirement according to each participant's performance. Thus, maximum cognitive effort is always required. Activities presented to the active control group will target orthogonal unrelated cognitive domains (i.e. artistic cognitive processes) and will be of constant difficulty.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: A home-based intervention will be set through the CogniFit® online platform. Participants will access remotely from home using a personal computer or smart device. The cognitive stimulation program will be held for 5 consecutive days (Monday to Friday) for 8 weeks, completing a total of 40 training sessions. Researchers will supervise the participant's performance daily and will periodically contact participants via telephone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 14, 2021

First Posted

June 8, 2022

Study Start

June 3, 2022

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

The data protection policy of the public health system of the Spanish government does not allow researchers to share individual participant data.

Locations

ES(1)