Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Post-session Assessment Completion
研究概览
简要总结
The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). Researchers hope to better understand the potential benefits of this intervention on brain tumor patients' mood and quality of life. This may lead to improvements in doctor's understanding of how to enhance brain tumor patient's wellbeing and overall functioning.
详细描述
In this study, participants will be asked to do the following things:
- Complete ~15-minute online surveys before the program, immediately after the program (4 months), and at follow-up (6 months). . Questions will ask about mood, anxiety, death distress, quality of social relationships, and satisfaction with life.
- Meet with an interventionist six times (biweekly) for individual sessions via Zoom, lasting 50-60 minutes each. Sessions will be audio-recorded to ensure all participants receive the same information. Participants will be asked to only use first names.
- Complete weekly ~5 minute online surveys after each session on satisfaction with the program.
- Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.
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
- •have a confirmed malignant brain cancer diagnosis via histopathology
- •be a minimum of 2 weeks post-surgical resection or biopsy (if applicable)
- •be primarily English speaking
- •be age 18-89
- •obtain >20 on the Telephone Interview for Cognitive Status (TICS)
- •have current elevated depression or death anxiety symptoms
- •have a reliable internet connection to participate in the Zoom therapy sessions
排除标准
- •Major communication difficulties as determined by the research team which would prohibit psychotherapeutic interaction
- •inability to meet with interventionist via an electronic device for telehealth intervention sessions
- •inability to provide informed consent
结局指标
主要结局
Post-session Assessment Completion
时间窗: 4 months
Number of participants completing post-session surveys
Recruitment for CALM
时间窗: 1 day
Number of potential participants consented and enrolled
Helpfulness of CALM Sessions
时间窗: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Average rating of CALM session helpfulness score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all helpful and 5 being very much helpful. Higher scores indicate greater helpfulness.
Utility of CALM
时间窗: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Average rating of CALM session utility score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all useful and 5 being very much useful. Higher scores indicate greater helpfulness.
Follow-up Assessment Completion
时间窗: 6 months
Number of participants that completed a follow-up survey
Satisfaction With CALM Sessions
时间窗: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Average rating of CALM session satisfaction score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.
Completion of CALM Sessions
时间窗: 3 months
Number of participants completing CALM sessions
Relevance of CALM
时间窗: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Average rating of CALM session relevance score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all relevant and 5 being very much relevant. Higher scores indicate greater helpfulness.
Intervention Satisfaction
时间窗: 3 month - one timepoint
Mean rating of intervention satisfaction score (average score across all participants who completed the CALM intervention - one timepoint). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.
Number of Participants Likely to Recommend the Program to Others
时间窗: 3 month timepoint
Rating of the likelihood of recommending the program to others.
次要结局
未报告次要终点