Informational Meetings for Planning and Coordinating Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 14
- 主要终点
- Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%
研究概览
简要总结
This prospective cluster-randomized trial examines the efficacy of a novel communication intervention delivered by trained physician and nurse dyads to parents of children with cancer within the clinicians' practice, to foster alignment of the goals of treatment. The investigators hypothesize that goal alignment will improve quality of life outcomes, in particular for those patients who reach end of life. Findings from the proposed research will provide essential information to promote communication practice standards that can be rapidly translated into practice to improve outcomes for children, particularly those who reach end of life, and parents.
详细描述
The overall objective of this study is to evaluate the efficacy of a novel communication intervention on quality of life outcomes in children with high-risk cancer. The intervention includes a series of tailored discussions delivered by the child's primary physician/nurse dyad that begins at diagnosis, and integrates visual aids to facilitate conversations with parents about prognosis, hopes, and goals-of-care across the cancer continuum. The central hypothesis is that the intervention will foster alignment of goals of care between providers and parents across the cancer continuum, leading to improved quality of life outcomes. Outcomes include: Enrollment in home hospice care, high-intensity medical interventions, child pain and emotional distress, parental hope, parental uncertainty and distress.
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
- Double (Participant, Outcomes Assessor)
盲法说明
A trained blinded evaluator will meet with participants to complete baseline and subsequent follow-up measures, including end-of-study chart review data. Physician-nurse dyads for each arm are trained differently and naive to alternate study arm.
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child 1 month to < 18 years
- •Child newly diagnosed, i.e., within 16 weeks (112 days) from time of diagnosis of cancer not including the day of diagnosis, OR
- •Child with relapsed cancer, defined as within 16 weeks (112 days) of first-time relapse/evidence of progression of disease as noted by scan or biopsy after previous diagnosis of cancer.
- •Child provide assent if age ≥ 7 years
- •Poor prognosis, i.e., approximate < 25 % estimated overall survival or at the discretion of the attending AND/OR:
- •Falls into one of the following diagnosis categories, including but not limited to:
- •Atypical teratoid rhabdoid tumor
- •Glioblastoma multiforme
- •Diffuse intrinsic brainstem glioma
- •Embryonal tumors with multilayered rosettes
- •Other high-grade glioma
- •Gliomatosis cerebri
- •Metastatic osteosarcoma
- •Metastatic Ewing sarcoma
- •Metastatic rhabdomyosarcoma
- •Metastatic desmoplastic small round cell tumor (DSRCT)
- •Other metastatic sarcoma/carcinoma-at discretion of attending
- •Metastatic unknown primary- or rare pathology- at discretion of attending
- •Parent(s) legal decision-maker(s) for child
- •Parent(s) ≥18 years of age
- •Parent (s) Informed of child's cancer diagnosis
- •Parent(s) Able to read, speak and understand English
- •Must be willing to be audio recorded during all study sessions.
排除标准
- •The parent has neurological/cognitive impairments likely to interfere with study participation;
- •The child ≥ 7 years of age does not provide assent
- •Parent refuses to be audio recorded during sessions.
研究组 & 干预措施
Enhanced Usual Care Parent Education
Parent(s) and patients receiving care from clinicians whose practice has been randomized to the enhanced usual care parent education group.
干预措施: Enhanced Usual Care Parent Education (Other)
Novel Communication Intervention
Parent(s) and patients receiving care from clinicians whose practice has been randomized to the novel communication intervention group.
干预措施: Novel Communication Intervention (Other)
结局指标
主要结局
Impact of Novel Communication Intervention on number of days enrolled in hospice in children with cancer and estimated 5-year survival < 25%
时间窗: Within 12 months of death
We will compare days enrolled in hospice between the Novel Communication Intervention vs Enhanced Usual Care Parent Education groups using a Wilcoxon Rank Sum Test for clustered data.
次要结局
- Impact of Novel Communication Intervention on quality of life in children with cancer and estimated 5-year survival < 25%(Enrollment, then every 4 months until death or maximum of 4 years)
- Impact of Novel Communication Intervention on parental satisfaction with healthcare(Enrollment, and then every 4 months until death or maximum of 4 years)
- Impact of Novel Communication Intervention on parental adjustment to caring for a child with cancer.(Enrollment, and then every 4 months until death or maximum of 4 years)
- Impact of the Novel Communication Intervention on the number and types of high-intensity medical interventions at end of life in children with cancer.(Within 30 days of death)
- Impact of the Novel Communication Intervention on parental hope.(Enrollment, and then every 4 months until death or maximum of 4 years)
研究者
Susan M Perkins
Professor of Biostatistics and Health Data Science
Indiana University