Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Brain Tumor

Treatments: Behavioral: Counseling Sessions; Behavioral: Quality of Life Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05789862

211013

NCI-2023-02189 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Virtual behavioral health

Experimental group

Description:

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.

Treatment:

Behavioral: Quality of Life Questionnaires

Behavioral: Counseling Sessions