Study of Attention and Memory Treatments for Cancer Survivors
NCT ID: NCT04870320
Last Updated: 2022-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2021-03-01
2022-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (Endeavor)
Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.
Endeavor: Computer-Based Cognitive Stimulation Intervention
Endeavor application will be utilized by participant on iPad
Quality of Life (QOL) Questionnaires
Standardized QOL questionnaire will be administered at each study visit
Arm II (Words!)
Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.
Words!: Computer-Based Cognitive Stimulation Intervention
Words! application will be utilized by participant on iPad
Quality of Life (QOL) Questionnaires
Standardized QOL questionnaire will be administered at each study visit
Interventions
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Endeavor: Computer-Based Cognitive Stimulation Intervention
Endeavor application will be utilized by participant on iPad
Words!: Computer-Based Cognitive Stimulation Intervention
Words! application will be utilized by participant on iPad
Quality of Life (QOL) Questionnaires
Standardized QOL questionnaire will be administered at each study visit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Have significant cognitive impairment
* Have sensory or motor deficits that prevent them from doing the assessment and using the application
18 Years
ALL
No
Sponsors
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Akili Interactive Labs, Inc.
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Christine Miaskowski, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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NCI-2021-02024
Identifier Type: REGISTRY
Identifier Source: secondary_id
19803
Identifier Type: -
Identifier Source: org_study_id
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