Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04870320
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-04-28
Brief Title:
Study of Attention and Memory Treatments for Cancer Survivors
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
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 patientssurvivors CRCI includes perceived or objective problems with memory executive function and attentionconcentration 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 ie Test of Variables of Attention TOVA ie attention Adaptive Cognitive Evaluation ACE ie 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 eg 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 ie Test of Variables of Attention TOVA ie attention Adaptive Cognitive Evaluation ACE ie 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 eg 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-02024 | REGISTRY | CTRP Clinical Trial Reporting Program | None |