Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05789862
• Other study ID #: 211013
• Secondary ID: NCI-2023-02189
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Jacob Young
• Phone: 877-827-3222
• Email: Jacob.Young[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Behavioral:
• Counseling Sessions
Virtual sessions
• Quality of Life Questionnaires
Self administered questionnaires

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Clarity Squared Behavioral, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Client Satisfaction Questionnaire (CSQ-8) score	The CSQ-8 is an 8 item measure that will be utilized to measure the satisfaction with the behavioral telehealth counseling sessions. Items in the questionnaire are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction). Total scores range from 8 to 32, with higher scores indicating a greater satisfaction. The mean and standard deviation for each question and total questionnaire will be calculated and reported by group.	6-9 months following surgery, approximately 1 day
Secondary	Mean Telehealth Usability Questionnaire (TUQ) score	The TUQ is a 21-question survey that was developed in response to the utilization of telehealth services in medical care. The survey is divided into 6 sections based on usefulness, ease-of-use, interface and interaction quality, reliability, satisfaction, and future use. Each question is scored on a 7-point Likert scale from 1 (Strongly Disagree) to 7 (Strongly Agree). The total score of each component is calculated by summing the item response scores in each component, with higher scores indicating a more positive experience with the intervention usability. The calculated mean and standard deviation by group will be reported.	6-9 months following surgery, approximately 1 day
Secondary	Proportion of participants with a Patient Health Questionnaire 9 (PHQ-9) score >= 5 over time	The PHQ-9 is used to measure depression symptoms. The total PHQ-9 score is calculated by combining the responses of the participant on questions addressing how bothered the participant has been by various problems over the past 2 weeks. Each of the 9 items is scored on a scale of 0 ("Not bothered at all") to 4 ("Nearly every day"). A total score of 5-9='Mild Depression Symptoms", 10-14="Minor Depression, Major Depression (mild), or Dysthymia", 15-19="Major Depression, moderately severe", and >20="Major Depression".	Up to 9 months
Secondary	Mean score on the PHQ-9 over time	The PHQ-9 is used to measure depression symptoms. The total PHQ-9 score is calculated by combining the responses of the participant on questions addressing how bothered the participant has been by various problems over the past 2 weeks. Each of the 9 items is scored on a scale of 0 ("Not bothered at all") to 4 ("Nearly every day"). A total score of 5-9='Mild Depression Symptoms", 10-14="Minor Depression, Major Depression (mild), or Dysthymia", 15-19="Major Depression, moderately severe", and >20="Major Depression". The PHQ-9 will be administered at Baseline, 4-6 weeks following surgery, and 6-9 months following surgery and the mean score and standard deviation will be reported.	Up to 9 months
Secondary	Mean change in score on the on the PHQ-9 over time	The overall mean change in score for each group on the PHQ-9 between the baseline visit and the second visit 4-6 weeks following surgery and the final follow-up visit, 6-9 months following surgery, will be reported.	Up to 9 months
Secondary	Mean score on the General Anxiety Disorder-7 questionnaire (GAD-7) over time	The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. The GAD-7 will be administered at Baseline, 4-6 weeks following surgery, and 6-9 months following surgery and the mean score and standard deviation will be reported.	Up to 9 months
Secondary	Mean change in score on the on the GAD-7 over time	The overall mean change in score for each group on the GAD-7 between the baseline visit and the second visit 4-6 weeks following surgery and the final follow-up visit, 6-9 months following surgery, will be reported.	Up to 9 months
Secondary	Proportion of participants with at least 1 positive response on the Mini International Neuropsychiatric Inventory - Screen (M.I.N.I) over time	The Mini International Neuropsychiatric Inventory - Screen (M.I.N.I) v7.0.2 is a brief, self-administered, structured interview designed to identify participants with positive responses for up to 19 adult behavioral disorders using Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria. A negative response to the screening questions usually means it is unlikely the participant has a major psychiatric disorder. A positive response to any questions in the M.I.N.I. Screen prompts the clinician to ask additional questions using the standard M.I.N.I. If a participant demonstrates a positive response, the M.I.N.I. Standard will be administered at that same time point. The M.I.N.I Screen will be administered at Baseline and 6-9 months following surgery	Up to 9 months
Secondary	Proportion of participants with individual diagnoses on the M.I.N.I. Standard over time	The M.I.N.I Standard is a full, clinician administered extended, structured interview which assesses the 17 most common disorders in mental health. The M.I.N.I. Standard will only be administered to participants with a positive response on the M.I.N.I Screen during the Baseline and 6-9 months following surgery assessments. Participants with negative responses at each assessment on the M.I.N.I Screen will not receive the M.I.N.I Standard at that assessment.	Up to 9 months
Secondary	Mean score on the European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire, Brain (EORTC QLQ-BN20) over time	The EORTC QLQ-BN20 consists of 20 questions; seven single item symptom scales (headaches, seizures, drowsiness, hair loss, itchy skin, leg weakness and bladder control), along with four multi-item scales (future uncertainty, visual disorder, motor dysfunction and communication deficit). Raw scores for the EORTC QLQ-BN20 items are computed by calculating the mean of the items in each subscale, or the item for each individual and linearly transform the scores to a 0-100 scale. A higher score represents worse QOL for all EORTC QLQ-BN20 scales and single items. The EORTC QLQ-BN20 will be administered at Baseline and 6-9 months following surgery	Up to 9 months
Secondary	Mean change in score on the EORTC QLQ-BN20 over time	The overall mean change in score for each group on the EORTC QLQ-BN20 between the baseline visit and final follow-up visit 6-9 months following surgery will be reported.	Up to 9 months