Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04870320
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Attention and Memory Treatments for Cancer Survivors
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
A Pilot Study of A Novel Cognitive Intervention for Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-02024 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |