Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Shawn Hervey-Jumper, MD (ucsf)
Headshot of Shawn Hervey-Jumper
Shawn Hervey-Jumper

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Keywords

Brain Tumor, Health Technologies, Virtual Health Counseling, Quality of Life, Brain Neoplasms, Virtual behavioral health

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age 18 years of age or older.
  2. Able to understand study procedures and to comply with them for the entire length of the study.
  3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
  4. Documented diagnosis of a brain tumor.
  5. PHQ-9 screening score of >= 5.
  6. No prior surgical intervention, other than biopsy, for brain tumor.
  7. Scheduled for craniotomy for brain tumor resection.

You CAN'T join if...

  1. Contraindication to any study-related procedure or assessment.
  2. PHQ-9 scores of:
    1. < 5
    2. >= 20
    3. >= 1 point on Question number 9 - thoughts of self-harm or suicidality.
  3. Require urgent or emergent surgical intervention or admission to the hospital prior to the scheduled surgery.
  4. Prior surgical intervention for brain tumor.
  5. Prior suicide attempt.
  6. Prior hospitalization for psychiatric treatment.
  7. Currently undergoing mental or behavioral health-related counseling or psychotherapy, other than currently taking an anti-depressant medication.

Location

  • University of California, San Francisco
    San Francisco California 94122 United States

Lead Scientist at University of California Health

  • Shawn Hervey-Jumper, MD (ucsf)
    Dr. Shawn Hervey-Jumper is a neurosurgeon with subspecialty focus on neuro-oncology. As an adult neurosurgeon and researcher his clinical efforts are focused on the surgical management of patients with intrinsic brain tumors such as glioma and brain metastasis within deep seated and functional regions of the brain responsible for language, motor, and cognition.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05789862
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated