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Breast CancerNCT05409248

Cognitive Stimulation and Chemobrain. An Innovative Intervention for Cancer Survivors

A study testing Personalized cognitive stimulation in people with Breast Cancer and Cognitive Decline, run by Universidad Antonio de Nebrija at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Cognitive Decline
What is being tested?
Personalized cognitive stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSpain
Study dates
3 Jun 2022to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jon A Duñabeitia contact

0034634423742

jdunabeitia@nebrija.es

Jose L Tapia contact

0034661157598

jtapia@nebrija.es

Spain1 site, 1 recruiting

  • Hospital la Ribera

    Alzira, Valencia, 46600

    Maria T Taberner, taberner_mte@gva.es

    Jose L Tapia, 661157598, jtapia@nebrija.es

    Recruiting

Other trials in Spain

About this study

Official title: Cognitive Stimulation Intervention Program for Cancer Survivors and Its Benefit on Cognitive Performance and Quality of Life

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.

Read the detailed description

A phase I/II/III clinical trial is proposed in which the first two phases will serve to evaluate the safety of the intervention and the maximum tolerated time of computerized cognitive training per session in the absence of adverse effects. The third phase will consist of a double-blind randomized controlled trial where the effectiveness of the personalized and self-administered computerized cognitive stimulation program will be evaluated.

Phase I. Based on a dose-escalation 3+3 design, experienced fatigue or adverse effects will be measured after succeeding 15 minutes cognitive stimulation training blocks. The training dose will be set to a block before extreme fatigue or notable adverse effect has been reported by two or more participants. A trained psychologist will supervise the process.

Phase II. To evaluate the effectiveness of the intervention, 20 participants will undertake an interspersed training day and evaluation day through 15 consecutive days. In this way, a total of 8 evaluation sessions (day 1, 3, 5, 7, 9, 11, 13, and 15) and 7 cognitive stimulation sessions (day 2, 4, 6, 8, 10, 12, and 14) will be carried out. A trained psychologist will supervise every step of the process.

Phase III. An 8-week personalized and computerized cognitive stimulation program will be established, where the training time per session will be as determined on phase I. 120 participants will be randomized 1:1 ratio to an intervention or active control group. All participants will undertake a pre and post-test, with a total of 40 training sessions (Monday to Friday) during 8 weeks. Although this phase is set to be an online home-based stage, the responsible psychologist will be monitoring participants' performance and will periodically contact participants via telephone.

Being tested
Personalized cognitive stimulation, Sham cognitive stimulation
Keywords
Breast cancer, Cancer survivors, Chemobrain, Cognitive stimulation, Online intervention
Medical subject headings
Breast Neoplasms, Cognitive Dysfunction, Chemotherapy-Related Cognitive Impairment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized cognitive stimulationOther

    Also called CogniFit's personalized brain training

    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.

  • 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.

Study groups in NCT05409248
Study groupRoleWhat they receive
Experimental GroupExperimentalOnline 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.
Receives: Other: Personalized cognitive stimulation
Control GroupActive comparatorOnline 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.
Receives: Other: Sham cognitive stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 8

  2. 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.

    Measured: Baseline and Week 8

  3. 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.

    Measured: Baseline and Week 8

Secondary outcomes (5)

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

    The STAI is a validated self-report that assesses anxiety that measures both trait and state anxiety. Each item is scored using a 4-point Likert scale. Possible scores range from 0 (no anxiety) to 60 (severe anxiety), for each category.

    Measured: Baseline and Week 8

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

    The BDI-II is a validated 21-item self-report inventory designed to measure the frequency and severity of depressive symptoms. Scores range from 0 (no depressive symptoms) to 63 (severe depression).

    Measured: Baseline and Week 8

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

    The BFI is a 9-items instrument designed to assess the severity and impact of cancer-related fatigue. For the three items that assess fatigue severity, scores range from 0 (no fatigue) to 10 (the worst fatigue you can imagine). For the six items that assess how fatigue interferes with daily life, scores range from 0 (does not interfere) to 10 (interferes completely).

    Measured: Baseline and Week 8

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

    The WHOQOL-BREF is a 26-question questionnaire designed to measure the quality of life. It has two questions concerning the general satisfaction with health, and the remaining 24 questions are grouped in four areas: physical health, psychological health, social relations, and environment. Scores for each domain range from 0 (poor perceived quality of life) to 100 (greater perceived quality of life)

    Measured: Baseline and Week 8

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

    The C-SSRS is a questionnaire designed to assess the existence of thoughts, desires or behaviors related to suicidal ideation, assessing a total of ten categories (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods without intent to act; active suicidal ideation with some intent to act, without a specific plan; active suicidal Ideation with a specific plan and intent; preparatory acts or behavior; aborted attempt; interrupted attempt; actual attempt; completed suicide. The questionnaire can be administered as a self-report, with additional open-ended follow-up questions to provide more information. Scoring refers to the presence or absence of each of the 10 categories, provided by the dichotomous responses (Yes/No).

    Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start3 Jun 2022
  3. Primary completionJul 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409248
Sponsor's protocol ID
CSCS
Status last verified
Jun 2022
First submitted
14 Oct 2021
Last updated
8 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data protection policy of the public health system of the Spanish government does not allow researchers to share individual participant data.

Publications

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

    PubMed 23023994

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

    PubMed 26353040

  • 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.

    PubMed 19760150

  • 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.

    PubMed 28056205

  • 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.

    PubMed 29497579

  • 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.

    PubMed 31147780

  • 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.

    PubMed 30231372

  • 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.

    PubMed 22658913

  • 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.

    PubMed 28029304

  • 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.

    PubMed 27668370

  • 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.

    PubMed 30131974

  • 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.

    PubMed 22901546

  • 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.

    PubMed 32004776

Questions about this trial

What is this clinical trial studying?

A study testing Personalized cognitive stimulation in people with Breast Cancer and Cognitive Decline, run by Universidad Antonio de Nebrija at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jon A Duñabeitia (0034634423742, jdunabeitia@nebrija.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in mini-Mental Adjustment to Cancer Scale (mini-MAC) at Week 8 (time frame: Baseline and Week 8). The study lists 3 primary outcomes in all. 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 NCT05409248, which also lists 13 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 8 Jun 2022.

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