Managing Distress in Malignant Brain Cancer - Phase IIc RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
研究概览
简要总结
The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)*
- •At least 2-weeks post-surgical resection or biopsy of the brain (if applicable)
- •Score > 20 on the TICS
- •Reported 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 the psychotherapeutic interaction
- •Inability to meet with the interventionist via an electronic device for telehealth intervention sessions
- •Inability to understand and provide informed consent
- •Prisoners
- •Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention.
结局指标
主要结局
Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
时间窗: 3 months
Percent of consented individuals who complete post-intervention questionnaires
Assess the feasibility of the CALM intervention- Consent Rate
时间窗: Day 0
Percent of eligible individuals who consent to the trial
Assess the feasibility of the CALM intervention- Screening Rate
时间窗: Day 0
Percent of interested individuals who undergo screening
Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate
时间窗: 6 months
Percent of consented individuals who complete follow-up questionnaires
Assess the feasibility of the CALM intervention- Intervention Retention Rate
时间窗: 3 months
Percent of consented individuals who complete the CALM intervention
Assess the acceptability of the CALM intervention- Participant Satisfaction
时间窗: 4 months
Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).
Assess the acceptability of the CALM intervention- Participant Recommendation Ratings
时间窗: 4 months
Percent of participants who would recommendation CALM to others will be assessed during the exit interview (e.g., Would you recommend this program to others?)
次要结局
未报告次要终点