Counseling for Brain Cancer

Overseen By Jacob Young

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Suicide attempt, Psychiatric hospitalization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it does allow participants to continue taking anti-depressant medication.

What data supports the effectiveness of the treatment Counseling Sessions, Quality of Life Questionnaires for brain cancer?

Research shows that assessing quality of life (QOL) in brain cancer patients can improve care and is an important measure in treatment outcomes. Regularly collecting QOL data helps understand patient well-being and can predict survival, making it a valuable part of treatment. ^{1 2 3 4 5}

Is counseling for brain cancer safe for humans?

The research does not provide specific safety data on counseling for brain cancer, but it does highlight the importance of evaluating quality of life, which can indirectly support patient well-being during treatment. ^{4 6 7 8 9}

How is the counseling treatment for brain cancer different from other treatments?

This counseling treatment is unique because it focuses on improving the quality of life for brain cancer patients by addressing their overall well-being, including work, daily activities, health, support systems, and mood, rather than just treating physical symptoms. ^{4 8 10 11 12}

Research Team

Shawn Hervey-Jumper, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults over 18 with a brain tumor diagnosis, who haven't had surgery except biopsy, and are scheduled for craniotomy. They must understand the study and consent to participate. Those with mild depression symptoms (PHQ-9 score >=5) can join but not if they have severe depression or suicidal thoughts.

Inclusion Criteria

Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it

I understand and can follow the study's procedures.

PHQ-9 screening score of >= 5

Exclusion Criteria

PHQ-9 score < 5

I have been hospitalized for psychiatric treatment before.

PHQ-9 score >= 20

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Assessment

Participants complete baseline assessments and engage in virtual counseling sessions before the craniotomy

Up to 4 weeks

1 visit (virtual)

Post-surgical Follow-up

Participants are assessed 4-6 weeks following surgery with questionnaires and virtual counseling sessions

4-6 weeks

1 visit (virtual)

Long-term Follow-up

Participants are monitored for mental health and quality of life 6-9 months following surgery

6-9 months

1 visit (virtual)

Treatment Details

Interventions

• Counseling Sessions
• Quality of Life Questionnaires

Trial Overview The trial tests virtual counseling sessions alongside standard care for patients undergoing craniotomy due to brain tumors. It's a single-arm feasibility study, meaning all participants receive the same intervention without being compared to another group.

Participant Groups

Group I: Virtual behavioral health Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Clarity Squared Behavioral, Inc

Collaborator

Trials

1

Recruited

30+

References

1. England pubmed.ncbi.nlm.nih.gov

Factors influencing quality of life in adult patients with primary brain tumors. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Implementation of computer-based quality-of-life monitoring in brain tumor outpatients in routine clinical practice. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Opportunities and challenges of incorporating clinical outcome assessments in brain tumor clinical trials. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Quality improvement of neuro-oncology services: integrating the routine collection of patient-reported, health-related quality-of-life measures. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The use of a simple Likert scale to measure quality of life in brain tumor patients. [2019]

6. Greece pubmed.ncbi.nlm.nih.gov

Analysis of health-related quality of life in patients with brain tumors prior and subsequent to radiotherapy. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A cross-sectional audit of distress in patients undergoing adjuvant therapy or follow-up in central nervous system malignancies. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Scale for assessing quality of life of children survivors of cranial posterior fossa tumors. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Development of a core outcome set and identification of patient-reportable outcomes for primary brain tumour trials: protocol for the COBra study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Use of a quality of life instrument to improve assessment of brain tumor patients in an outpatient setting. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Development of a concise QOL questionnaire for brain tumor patients. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Validity and Reliability of Turkish Version of the Functional Assessment of Cancer Therapy-Brain Questionnaire. [2018]