NCT05789862

Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy

A Comprehensive Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy for Brain Tumor

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Tumor

Interventions

Type	Name	Description
BEHAVIORAL	Counseling Sessions	Virtual sessions
BEHAVIORAL	Quality of Life Questionnaires	Self administered questionnaires

Timeline

• Start date: 2025-12-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-03-29
• Last updated: 2025-08-29