A Comprehensive Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy for Brain Tumor
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- Proportion of participants who completed program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=
- •No prior surgical intervention, other than biopsy, for brain tumor.
- •Scheduled for craniotomy for brain tumor resection.
排除标准
- •Contraindication to any study-related procedure or assessment.
- •PHQ-9 scores of:
- •>= 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.
- •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.
研究组 & 干预措施
Virtual behavioral health
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.
干预措施: Counseling Sessions (Behavioral)
Virtual behavioral health
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.
干预措施: Quality of Life Questionnaires (Behavioral)
结局指标
主要结局
Proportion of participants who completed program
时间窗: 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.
次要结局
- Mean Client Satisfaction Questionnaire (CSQ-8) score(6-9 months following surgery, approximately 1 day)
- Proportion of participants with a Patient Health Questionnaire 9 (PHQ-9) score >= 5 over time(Up to 9 months)
- Mean score on the PHQ-9 over time(Up to 9 months)
- Mean change in score on the on the PHQ-9 over time(Up to 9 months)
- Mean score on the General Anxiety Disorder-7 questionnaire (GAD-7) over time(Up to 9 months)
- Mean Telehealth Usability Questionnaire (TUQ) score(6-9 months following surgery, approximately 1 day)
- Mean score on the European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire, Brain (EORTC QLQ-BN20) over time(Up to 9 months)
- Mean change in score on the on the GAD-7 over time(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(Up to 9 months)
- Proportion of participants with individual diagnoses on the M.I.N.I. Standard over time(Up to 9 months)
- Mean change in score on the EORTC QLQ-BN20 over time(Up to 9 months)