Brain TumorNCT05789862
Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy
A study testing Counseling Sessions and Quality of Life Questionnaires in people with Brain Tumor, run by University of California, San Francisco.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Counseling Sessions and Quality of Life Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Comprehensive Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy for Brain Tumor
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Brain Tumor
- Being tested
- Counseling Sessions, Quality of Life Questionnaires
- Keywords
- Health Technologies, Virtual Health Counseling, Quality of Life
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling SessionsBehavioural
Also called Behavioral health counseling sessions
Virtual sessions
Quality of Life QuestionnairesBehavioural
Also called Health related quality of life assessment (HRQoL)
Self administered questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Counseling Sessions; Behavioral: Quality of Life Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 9 months
Secondary outcomes (11)
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.
Measured: 6-9 months following surgery, approximately 1 day
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.
Measured: 6-9 months following surgery, approximately 1 day
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".
Measured: Up to 9 months
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.
Measured: Up to 9 months
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.
Measured: Up to 9 months
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.
Measured: Up to 9 months
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.
Measured: Up to 9 months
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
Measured: Up to 9 months
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.
Measured: Up to 9 months
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
Measured: Up to 9 months
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.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Sponsor portfolio adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Clarity Squared Behavioral, Inc
- Responsible party
- Sponsor
- Investigators
- Shawn Hervey-Jumper, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789862
- Sponsor's protocol ID
- 211013
- Other IDs
- NCI-2023-02189
- Status last verified
- Aug 2025
- First submitted
- 16 Mar 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy for Brain Tumor
- ClinicalTrials.gov ID
- NCT05789862
- Acronym / sponsor ID
- 211013
- Conditions
- Brain Tumor
- Keywords
- Health Technologies, Virtual Health Counseling, Quality of Life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor portfolio adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Clarity Squared Behavioral, Inc
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual behavioral health | Experimental | Behavioral: Counseling Sessions, Behavioral: Quality of Life QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- Contraindication to any study-related procedure or assessment.
- PHQ-9 scores of:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling SessionsAlso: Behavioral health counseling sessionsVirtual sessions | Behavioural | Virtual behavioral health |
| Quality of Life QuestionnairesAlso: Health related quality of life assessment (HRQoL)Self administered questionnaires | Behavioural | Virtual behavioral health |
Primary outcome
Proportion of participants who completed program
Time frame: Up to 9 months
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.
11 secondary outcomes
Mean Client Satisfaction Questionnaire (CSQ-8) score
Time frame: 6-9 months following surgery, approximately 1 day
Mean Telehealth Usability Questionnaire (TUQ) score
Time frame: 6-9 months following surgery, approximately 1 day
Proportion of participants with a Patient Health Questionnaire 9 (PHQ-9) score >= 5 over time
Time frame: Up to 9 months
Mean score on the PHQ-9 over time
Time frame: Up to 9 months
Mean change in score on the on the PHQ-9 over time
Time frame: Up to 9 months
Mean score on the General Anxiety Disorder-7 questionnaire (GAD-7) over time
Time frame: Up to 9 months
Mean change in score on the on the GAD-7 over time
Time frame: Up to 9 months
Proportion of participants with at least 1 positive response on the Mini International Neuropsychiatric Inventory - Screen (M.I.N.I) over time
Time frame: Up to 9 months
Proportion of participants with individual diagnoses on the M.I.N.I. Standard over time
Time frame: Up to 9 months
Mean score on the European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire, Brain (EORTC QLQ-BN20) over time
Time frame: Up to 9 months
Mean change in score on the EORTC QLQ-BN20 over time
Time frame: Up to 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Hervey-Jumper, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Counseling Sessions and Quality of Life Questionnaires in people with Brain Tumor, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who completed program (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.