Brief Intervention to Reduce Anxiety and Promote Resilience in Caregivers of Youth With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of caregivers who enroll in the GOLD program
研究概览
简要总结
The purpose of this study is to examine a psychotherapeutic and psycho-educational intervention offered in virtual settings to caregivers of youth with cancer. Human subjects must be used because they are the object of the intervention.
详细描述
PRIMARY OBJECTIVE(S)- To examine the feasibility and accessibility of a brief intervention for caregivers of youth with newly-diagnosed cancer as a preliminary, data-generating step toward applying for a larger NCI R34 grant evaluating the efficacy of the program in a randomized controlled trial.
SECONDARY OBJECTIVE(S)- We hope to learn whether a psycho-educational, psychotherapeutic intervention offered in a virtual setting to caregivers of children diagnosed with cancer is feasible, is acceptable, and can prevent, minimize, or improve symptoms of psychological distress (including symptoms of anxiety, depression, and post-traumatic stress disorder). We also hope to further our understanding of family stress and expand the idea for a need of mental health services in pediatric oncology. We aim to further understand intervention strategies for domains of family stress, reducing levels of caregiver anxiety, and promoting resilience for caregivers. This is important because these symptoms can affect the quality of life of caregivers and affect their ability to adhere to their children's treatments.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion and
排除标准
- •Child (0-17yrs) with recent (<12 mo) cancer diagnosis
- •Fluent in English
- •Consent to research
- •Lack of proficiency in written and spoken English
- •Parent is under age 18
- •Active Suicidal Ideation
- •Child with cancer does not provide assent
- •Inclusion and Exclusion Criteria: Children
- •Recent (<12 mo) cancer diagnosis in child
- •8-17 Years old
- •Provides assent to participate in the study
- •Cannot read English
- •Parent is not enrolled in the study
- •Anyone who is not a caregiver of children who have been diagnosed with cancer within the past 12 months will be excluded.
研究组 & 干预措施
GOLD Psychosocial Program
Participant will receive a 2-hour interventional session. Its content will consist of two modules: (1) psychoeducation and coping, providing information in content areas such as side effects of cancer treatments, fever protocols, role disruption and (2) stress, triggers, and self care, where caregivers will be briefed on symptoms of and reactions to traumatic stress in order to help parents accurately label thoughts and emotions related to their child's cancer diagnosis.
干预措施: GOLD Program (Behavioral)
结局指标
主要结局
Number of caregivers who enroll in the GOLD program
时间窗: 1 month
Measurement will be based on the percentage of caregivers who provide consent, and are retained in the program through 1-month follow-up.
次要结局
- Acceptability of the GOLD Program for caregivers(1 month)