Study of Attention and Memory Treatments for Cancer Survivors
30 mars 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
49
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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California
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San Francisco, California, Förenta staterna, 94143
- University of California San Francisco
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
Standardized QOL questionnaire will be administered at each study visit
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|
Aktiv komparator: Arm II (Words!)
Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.
|
Standardized QOL questionnaire will be administered at each study visit
Words! application will be utilized by participant on iPad
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of participants who completed the study
Tidsram: Up to 6 weeks
|
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
Tidsram: 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.
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
|
|
Percent change in scores on the TOVA over time
Tidsram: 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
|
|
Mean changes in Adaptive Cognitive Evaluation (ACE)
Tidsram: 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 in means from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
|
|
Percent change in scores on the ACE over time
Tidsram: 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
Tidsram: Up to 4 weeks
|
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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)
Tidsram: Up to 4 weeks
|
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
Tidsram: Up to 4 weeks
|
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)
Tidsram: 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.
|
Up to 4 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Christine Miaskowski, RN, PhD, University of California, San Francisco
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2021
Primärt slutförande (Faktisk)
31 januari 2022
Avslutad studie (Faktisk)
31 januari 2022
Studieregistreringsdatum
Först inskickad
28 april 2021
Först inskickad som uppfyllde QC-kriterierna
28 april 2021
Första postat (Faktisk)
3 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 mars 2022
Senast verifierad
1 mars 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 19803
- NCI-2021-02024 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Plan för individuella deltagardata (IPD)
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Nej
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Nej
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