Viewing Study NCT05789862



Ignite Creation Date: 2024-05-06 @ 6:47 PM
Last Modification Date: 2024-10-26 @ 2:55 PM
Study NCT ID: NCT05789862
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-08
First Post: 2023-03-16

Brief Title: Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy
Sponsor: University of California San Francisco
Organization: University of California San Francisco

Study Overview

Official Title: A Comprehensive Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy for Brain Tumor
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
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 is a single center non-randomized single-arm feasibility trial of the implementation of virtual behavioral health counseling sessions alongside standard-of-care treatment
Detailed Description: PRIMARY OBJECTIVE

I Determine the feasibility of implementing behavioral health counseling sessions alongside standard of care treatment for brain tumor participants scheduled to undergo craniotomy for treatment

SECONDARY OBJECTIVE

I To assess the acceptance of virtual behavioral health counseling sessions during the initial management of a newly diagnosed brain tumor

II To explore the rates of pre- and post-surgical mental health disorders in participants newly diagnosed with a brain tumor

III To explore pre- and post-surgical quality of life with virtual behavioral health counseling sessions during the initial management of a newly diagnosed brain tumor

OUTLINE

Participants will be given the opportunity to participate in virtual behavioral health counseling sessions at three time points relative to the scheduled tumor resection operation All participants will receive questionnaires related to mental health quality of life and satisfaction with the study intervention Participants who do not want to participate in the counseling sessions will be provided the option to complete the assessment tools related to mental health and quality of life only Participants will be assessed over the course of 9 months related to standard-of-care treatment at the following time points before the operation baseline 4 to 6 weeks following the operation and 6 to 9 months following the operation At each time point the participants will fill out the questionnaires and engage in the virtual counseling sessions

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?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-2023-02189 REGISTRY NCI Clinical Trials Reporting Program CTRP None