Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545045
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Cognitive Rehabilitation Following Breast Cancer Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance cognition and quality of life in breast cancer survivors with cancer-related cognitive impairment CRCI The other goal of this proposed project is to examine the effects of CO-OP on resting rsFC- and task-state functional connectivity as compared to an inactive control group
Detailed Description:
Breast cancer survivors often self-report cognitive deficits primarily in executive functioning planning problem solving multitasking memory and processing speed after cancer treatment ie cancer-related cognitive impairment CRCI The prevalence of CRCI following breast cancer is as high as 78 and can persist chronically after treatment has ended In other health conditions associated with cognitive impairment such as traumatic brain injury the only evidence-based recommended practice standard for deficits in executive function is metacognitive strategy training MCST In this approach participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to successfully engage in an activity While the cognitive deficits identified in and described by breast cancer survivors seem quite amenable to MCST there is no study in the published literature which measures the efficacy of MCST on CRCI The Cognitive Orientation to daily Occupational Performance CO-OP approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity Preliminary data suggest that CO-OP may have a positive impact on subjective and objective cognitive performance in breast cancer survivors with CRCI Further this study will evaluate the neurophysiological underpinnings associated with treatment changes through the use of neuroimaging methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None