Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit (RIGHTimeCPV) Pilot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Percentage of participants who engage in at least one cycle of intervention
研究概览
简要总结
The purpose of this research study is to obtain insights and feedback from patients and parents about a new approach to support conversations about how cancer may affect one's future life and quality of life (i.e., prognostic communication). This study involves creating a personalized approach to discussing prognosis.
Primary Objectives
- To evaluate the feasibility of implementing the RIGHTimeCPV intervention among pediatric oncology patients, caregivers, and clinicians (referred to herein as "shareholders").
- To assess the acceptability of the intervention across the shareholder groups.
Secondary Objectives
- To explore the potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding, and therapeutic alliance between patients/families and multidisciplinary clinicians.
- To explore whether the practice of eliciting, sharing, and honoring individualized communication preferences is sustained by clinicians after participation in the RIGHTimeCPV intervention.
详细描述
An estimated range of 52-85 total participants across all subject cohorts at St. Jude and participating affiliate sites, including 12-15 pediatric oncologists, 2-3 family units per participating oncologist (with an emphasis on dyadic recruitment within a given family unit, but also may include independent patients, independent caregivers, or a patient and multiple caregivers; estimated 15-25 patients and 15-25 parents), and 10-20 'communication preferences companions' (CPCs).
The RIGHTimeCPV intervention centers eliciting, sharing, and integrating individualized patient/parent preferences for prognostic communication into routine clinical practice through collaboration between multidisciplinary clinicians on the care team.
The intervention comprises five parts: 1) patient/parent identifies and selects a CPC; 2) CPC reviews intervention materials and conversation guide with the research team; 3) CPC and patient/parent meet for a CPV visit, and CPC documents patient/parent preferences in a templated form; 4) CPC and oncologist discuss the CPV form; 5) oncologist, patient/parent, and CPC attend next disease re-evaluation visit together.
Data will be collected at the following timepoints: 1) study enrollment (routine demographic information collected from each participant); 2) CPV 'conversation guide' training with CPC and research staff (audio-recorded encounter); 3) CPV with patient/parent and CPC (audio-recorded encounter); 4) during the period after a CPV and before the next disease re-evaluation encounter (brief survey and semi-structured interview for patients/parents and oncologists); 5) CPC-oncologist discussion to review the CPV form (email or audio-recorded encounter); 6) disease re-evaluation visit with patient/parent, oncologist, and CPC (audio-recorded encounter); 7) post-intervention interview (brief surveys for patients/parents and oncologists and semi-structured interviews for all participants); and 8) post-intervention interview six months after the final DRV (semi-structured interviews for all participants).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 12-25 years diagnosed with poor prognosis cancer (high risk or otherwise difficult to treat cancers), as defined by a pediatric oncologist estimating odds of overall survival as 50% or less
- •Anticipated by a pediatric oncologist to have one or more disease re-evaluation timepoints over the next six months
- •Not anticipated by a pediatric oncologist to approach end of life in the next three months
- •Inclusion Criteria: Parents/Caregivers
- •Aged 18 years or older and/or legally emancipated
- •Parent or other self-identified caregiver of a patient of any age with poor prognosis cancer (as defined above)
- •Inclusion Criteria: Oncologists
- •Pediatric oncologists who treat eligible patients/caregivers at the study site, St. Jude Children's Research Hospital (SJCRH) or its included affiliates:
- •Peoria, IL: The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic
- •Charlotte, NC: Novant Health Hemby Children's Hospital
- •Shreveport, LA: Ochsner LSU Health-Feist-Weiller Cancer Center
- •Inclusion Criteria: Communication Preferences Companions (CPCs)
- •Multidisciplinary clinicians from a participant's psychosocial or nursing care team, identified by that participant to serve as their 'communication preferences companion' (CPC) during the pilot
- •Provides clinical care to pediatric cancer patients under the auspices of psychology, social work, spiritual care, child life, cultural navigation, quality of life/palliative care, or nursing
排除标准
- •Does not meet the stated inclusion criteria
研究组 & 干预措施
RIGHTimeCPV intervention: Patients and Caregivers (parents)
Pediatric patients aged 12-25 years with poor prognosis cancer who receive treatment at the study site or participating affiliate
Caregivers of patients of any age who receive treatment at the study site (referred to as 'parent')
干预措施: Prognostic Communication-Patient/parent (Behavioral)
RIGHTimeCPV intervention: Psychosocial/nursing clinicians
Psychosocial/nursing clinicians who participate in the clinical care of participating patients/parents and serve as communication preferences companions (CPCs) under the auspices of this study
干预措施: Prognostic Communication-CPC (Behavioral)
RIGHTimeCPV intervention: Pediatric oncologists
Pediatric oncologists who treat participating patients/parents
干预措施: Prognostic Communication-Oncologist (Behavioral)
结局指标
主要结局
Percentage of participants who engage in at least one cycle of intervention
时间窗: 6 months after the final DRV during study exit interviews [participant specific
The percentages of participating patients, parents, and multidisciplinary clinicians who engage in at least one cycle of the intervention.
Feasibility of implementing the RIGHTimeCPV intervention
时间窗: Between Day 1-30 after a Disease Reevaluation Visit (DRV) [participant specific] and again 6 months after the final DRV during study exit interviews [participant specific
Quantitative findings of feasibility will be assessed using the Feasibility of Intervention Measure (FIM). The FIM measure includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score. Feasibility is standardly considered to be achieved with a mean score ≥3 for this measure. Higher scores indicate greater perceived feasibility of the intervention.
Acceptability of implementing the RIGHTimeCPV intervention
时间窗: Between Day 1-30 after a Disease Reevaluation Visit (DRV) [participant specific] and again 6 months after the final DRV during study exit interviews [participant specific
Quantitative findings of acceptability will be assessed using the Acceptability of Intervention Measure (AIM). The AIM measure includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score. Acceptability is standardly considered to be achieved with a mean score ≥3 for this measure. Higher scores indicate greater perceived acceptability.
次要结局
- Potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding, and therapeutic alliance between patients/families and multidisciplinary clinicians(Between Day 1-30 after the CPV timepoint [participant specific], between Day 1-30 after the DRV timepoint [participant specific], and 6 months after the final DRV during study exit interviews [participant specific)
- Whether the practice of eliciting, sharing, and honoring individualized communication preferences is sustained by clinicians after participation in the RIGHTimeCPV intervention(6 months after the final DRV during study exit interviews [participant specific)