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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
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.
Show all 10Show fewer
  • 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:

  1. 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:

  1. 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 groups in NCT05789862
Study groupRoleWhat they receive
Virtual behavioral healthExperimentalParticipants 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.

  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.

    Measured: Up to 9 months

Secondary outcomes (11)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted29 Mar 2023
  2. Study start31 Dec 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Why it stopped: Sponsor portfolio adjustment

Resources

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)
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

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.

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