Study of Attention and Memory Treatments for Cancer Survivors
30 marca 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
49
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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California
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San Francisco, California, Stany Zjednoczone, 94143
- University of California San Francisco
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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
Inne nazwy:
Standardized QOL questionnaire will be administered at each study visit
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Aktywny komparator: 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
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of participants who completed the study
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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)
Ramy czasowe: 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
Ramy czasowe: 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 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Christine Miaskowski, RN, PhD, University of California, San Francisco
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 marca 2021
Zakończenie podstawowe (Rzeczywisty)
31 stycznia 2022
Ukończenie studiów (Rzeczywisty)
31 stycznia 2022
Daty rejestracji na studia
Pierwszy przesłany
28 kwietnia 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
28 kwietnia 2021
Pierwszy wysłany (Rzeczywisty)
3 maja 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
8 kwietnia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
30 marca 2022
Ostatnia weryfikacja
1 marca 2022
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 19803
- NCI-2021-02024 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
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