Study of Attention and Memory Treatments for Cancer Survivors
30 marzo 2022 aggiornato da: University of California, San Francisco
A Pilot Study of A Novel Cognitive Intervention for Cancer Survivors
This clinical trial investigates if certain electronic games may be effective in improving attention and memory function in cancer survivors.
Cancer related cognitive impairment (CRCI) is an issue experienced by many cancer patients/survivors.
CRCI includes perceived or objective problems with memory, executive function, and attention/concentration. CRCI has a negative impact on survivors' ability to work, carry out routine activities, and engage in social and family relationships.
CRCI may result in significant distress and reduced quality of life.
Certain electronic games may help improve attention and memory function in cancer survivors and reduce symptoms of CRCI.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Determine the recruitment and retention rates for both arms of this study. II. Determine the effect size for changes in cognitive function (i.e., Test of Variables of Attention (TOVA) [i.e. attention], Adaptive Cognitive Evaluation (ACE) [i.e. working memory]) in the intervention group compared to the control group following the 4-week study.
III. Evaluate adherence rates for and satisfaction with the interventions. IV. Evaluate for treatment-related adverse events (e.g., nausea, motion sickness).
SECONDARY OBJECTIVE:
I. To determine effect sizes for depression, fatigue, and sleep disturbance, by comparing changes in the intervention group to changes in the control group, following the 4-week study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.
ARM II: Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
49
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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San Francisco, California, Stati Uniti, 94143
- University of California San Francisco
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Attention Function Index (AFI) score of < 7.5
- Are able to read, write, and understand English
- Ability to understand an electronic informed consent document, and the willingness to sign it
- Have a Karnofsky performance status (KPS) score of >= 50
- Have access to WiFi connection
Exclusion Criteria:
- Receiving active treatment for cancer recurrence
- Have significant cognitive impairment
- Have sensory or motor deficits that prevent them from doing the assessment and using the application
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Arm I (Endeavor)
Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.
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Endeavor application will be utilized by participant on iPad
Altri nomi:
Standardized QOL questionnaire will be administered at each study visit
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Comparatore attivo: Arm II (Words!)
Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.
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Standardized QOL questionnaire will be administered at each study visit
Words! application will be utilized by participant on iPad
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of participants who completed the study
Lasso di tempo: Up to 6 weeks
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Completion is defined as participants who completed all 4 weeks of intervention and final assessment.
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Up to 6 weeks
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Mean change in scores on the Test of Variables of Attention (TOVA) over time
Lasso di tempo: Up to 4 weeks
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The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch.
The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance).
Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age.
Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits.
The mean change in scores will be estimated as the norm-based standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
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Percent change in scores on the TOVA over time
Lasso di tempo: Up to 4 weeks
|
The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch.
The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance).
Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age.
Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits.
Will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
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Mean changes in Adaptive Cognitive Evaluation (ACE)
Lasso di tempo: Up to 4 weeks
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The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface.
The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
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Percent change in scores on the ACE over time
Lasso di tempo: Up to 4 weeks
|
The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface.
The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
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Proportion of time using application
Lasso di tempo: Up to 4 weeks
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Adherence rate will be evaluated by comparing the amount of time the participant should have used the application to the actual amount of time the participant used the application.
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Up to 4 weeks
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Percentage of participants who experienced treatment-related adverse events
Lasso di tempo: Up to 6 weeks
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Safety analyses will involve examination of and comparison between groups for the percentage of participants by adverse event severity and type of treatment-related adverse events.
Comparisons of the frequencies between groups will be conducted using Chi-square or Fisher's exact test.
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Up to 6 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)
Lasso di tempo: Up to 4 weeks
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The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week.
Responses are rated on a 5 point Likert scale with response option ranging 0="Rarely or none of the time (less than 1 day )" to 4='Most or all of the time (5-7 days)".
The scoring of positive items is reversed.
Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology and will be estimated as the standardized difference in means of each measure at the last assessment from enrollment to the last assessment.
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Up to 4 weeks
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Change in mean severity scores on the Lee Fatigue Scale
Lasso di tempo: Up to 4 weeks
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The Lee Fatigue Scale is used to measure the impact of fatigue on a participants quality of life.
The scale consists of 18 items relating to the subjective experience of fatigue.
Each item is rated on a 0 to 10 numeric rating scale (e.g., from "not at all tired" to "extremely tired").
Scores can range from 0 to 10.
The instrument has two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10).
The fatigue subscale score is calculated as the mean of the 13 fatigue items and the energy subscale score is the mean of the 5 energy items.
Higher scores on the fatigue subscale represent greater fatigue severity, and higher scores on the energy subscale indicate higher levels of energy and will be estimated as the standardized difference in means of each measure at the last assessment from enrollment to the last assessment.
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Up to 4 weeks
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Change in severity scores on the General Sleep Disturbance Scale (GSDS)
Lasso di tempo: Up to 4 weeks
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The GSDS consists of 21 items related to frequency in the past month of difficulty getting to sleep when respondents were asked to think about the past month, and each response is on a 8-point Likert scale from 0 ("never") to 7 ("all the time").
Will be estimated as the standardized difference in means of each measure at the last assessment, and as the difference between the groups in the percent change from enrollment to the last assessment.
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Up to 4 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Christine Miaskowski, RN, PhD, University of California, San Francisco
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 marzo 2021
Completamento primario (Effettivo)
31 gennaio 2022
Completamento dello studio (Effettivo)
31 gennaio 2022
Date di iscrizione allo studio
Primo inviato
28 aprile 2021
Primo inviato che soddisfa i criteri di controllo qualità
28 aprile 2021
Primo Inserito (Effettivo)
3 maggio 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 aprile 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 marzo 2022
Ultimo verificato
1 marzo 2022
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 19803
- NCI-2021-02024 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .