Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy

NCT05789862 | Withdrawn

• 2 other identifiers: 211013NCI-2023-02189
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Tumor

Keywords

Health Technologies; Virtual Health Counseling; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who completed program

  The proportion of enrolled patients that complete all three virtual behavioral health counseling sessions from time of study enrollment to the final behavioral health counseling session, approximately 6-9 months following the participants surgical operation, will be reported.

  Up to 9 months

Secondary Outcomes (11)

• Mean Client Satisfaction Questionnaire (CSQ-8) score

  6-9 months following surgery, approximately 1 day

• Mean Telehealth Usability Questionnaire (TUQ) score

  6-9 months following surgery, approximately 1 day

• Proportion of participants with a Patient Health Questionnaire 9 (PHQ-9) score >= 5 over time

  Up to 9 months

• Mean score on the PHQ-9 over time

  Up to 9 months

• Mean change in score on the on the PHQ-9 over time

  Up to 9 months

Study Arms (1)

Virtual behavioral health

EXPERIMENTAL

Participants will be assessed at 3 time points over the course the standard-of-care treatment before and after a scheduled craniotomy. At each time point, the participants will be asked to complete the questionnaires and engage in virtual counseling sessions.

Behavioral: Counseling Sessions; Behavioral: Quality of Life Questionnaires

Interventions

Counseling Sessions BEHAVIORAL

Virtual sessions

Also known as: Behavioral health counseling sessions

Virtual behavioral health

Quality of Life Questionnaires BEHAVIORAL

Self administered questionnaires

Also known as: Health related quality of life assessment (HRQoL)

Virtual behavioral health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Clarity Squared Behavioral, Inc: collaborator

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shawn Hervey-Jumper, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share