Clinical trial NCT05789862: Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy
Official title: A Comprehensive Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy for Brain Tumor
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Tumor
Keywords: Health Technologies
Virtual Health Counseling
Quality of Life
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Clarity Squared Behavioral, Inc
First posted: 2023-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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.

Primary outcomes:
measure: Proportion of participants who completed program
timeFrame: Up to 9 months
Secondary outcomes:
measure: Mean Client Satisfaction Questionnaire (CSQ-8) score
timeFrame: 6-9 months following surgery, approximately 1 day
measure: Mean Telehealth Usability Questionnaire (TUQ) score
timeFrame: 6-9 months following surgery, approximately 1 day
measure: Proportion of participants with a Patient Health Questionnaire 9 (PHQ-9) score >= 5 over time
timeFrame: Up to 9 months
measure: Mean score on the PHQ-9 over time
timeFrame: Up to 9 months
measure: Mean change in score on the on the PHQ-9 over time
timeFrame: Up to 9 months
measure: Mean score on the General Anxiety Disorder-7 questionnaire (GAD-7) over time
timeFrame: Up to 9 months
measure: Mean change in score on the on the GAD-7 over time
timeFrame: Up to 9 months
measure: Proportion of participants with at least 1 positive response on the Mini International Neuropsychiatric Inventory - Screen (M.I.N.I) over time
timeFrame: Up to 9 months
measure: Proportion of participants with individual diagnoses on the M.I.N.I. Standard over time
timeFrame: Up to 9 months
measure: Mean score on the European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire, Brain (EORTC QLQ-BN20) over time
timeFrame: Up to 9 months
measure: Mean change in score on the EORTC QLQ-BN20 over time
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Shawn Hervey-Jumper, MD
role: PRINCIPAL_INVESTIGATOR
References: