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Trial Title:
Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy
NCT ID:
NCT05789862
Condition:
Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Conditions: Keywords:
Health Technologies
Virtual Health Counseling
Quality of Life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Counseling Sessions
Description:
Virtual sessions
Arm group label:
Virtual behavioral health
Other name:
Behavioral health counseling sessions
Intervention type:
Behavioral
Intervention name:
Quality of Life Questionnaires
Description:
Self administered questionnaires
Arm group label:
Virtual behavioral health
Other name:
Health related quality of life assessment (HRQoL)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94122
Country:
United States
Contact:
Last name:
Jacob Young, MD
Phone:
877-827-3222
Email:
Jacob.Young@ucsf.edu
Contact backup:
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Shawn Hervey-Jumper, MD
Email:
Principal Investigator
Investigator:
Last name:
Jacob Young, MD
Email:
Sub-Investigator
Start date:
August 30, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Clarity Squared Behavioral, Inc
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789862
