Managing Distress in Malignant Brain Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains
研究概览
简要总结
To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.
详细描述
Single-arm, mixed-methods, Phase IIa, proof-of-concept trial to inform CALM adaptations for service members (SMs), Veterans, their beneficiaries, and civilians with bMET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology
- •At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)
- •Score > 20 on the TICS
- •Report elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
- •Ability to read, speak, and understand English
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Major communication difficulties, which would prohibit psychotherapeutic interaction
- •Inability to meet with interventionist via an electronic device for telehealth intervention sessions
- •Inability to understand and provide informed consent
- •Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk
结局指标
主要结局
Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains
时间窗: 4 Months
At the exit interview, participants will be asked to rate the applicability of the four CALM domains on a Likert Scale from 1 (not applicable) to 5 (very applicable). The four CALM domains are as follows: Domain 1) represents symptom management and communication with healthcare providers, Domain 2) reflects changes in personal relationships, Domain 3) sense of meaning and purpose, and Domain 4) the future, hope and mortality. Higher scores mean greater applicability.
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions
时间窗: 3 Months
Percent of sessions attended across all participants
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent.
时间窗: 12 months
Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion
时间窗: 3 Months
Percent of post-session surveys completed by participants immediately after the intervention
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion
时间窗: 3 Months
Percent of post-intervention surveys completed
Benefit of Intervention in the Proof of Concept Project
时间窗: 4 Months
Benefit will be assessed by participant responses to a question during the exit interview (e.g., Rate your overall benefit on a scale of 1-5).
次要结局
未报告次要终点