Palliative Care Integration in Pediatric Oncology Phase 1 Clinical Trials
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Feasibility
研究概览
简要总结
Although cure rates continue to rise, one in five children with cancer still die from their disease, so new therapies are urgently needed. Most advances in childhood cancer treatments have originated through clinical trial research and new therapies must be tested in early phase clinical trials. Phase 1 clinical trials are designed to focus mainly on determining whether a drug is safe, and less on how well it cures a disease. These trials may offer patients and families hope when no other options are available to treat their cancer. However, patients in these trials may also experience treatment-related side effects and earlier death. Patients and families enrolled in phase 1 clinical trials often experience increased levels of distress. This distress may result from physical effects of the disease or treatments, or from worry, sadness, or confusion when making difficult decisions related to care or end-of-life.
Pediatric palliative care (PPC) is a field that aims to ease physical, psychological, emotional, and spiritual suffering and may be beneficial to patients and families enrolling in phase 1 clinical trials. Over the past decade, PPC has been shown to improve quality of life, patient and family healthcare understanding and satisfaction, communication, shared-medical decision making, advanced care planning, and healthcare cost savings. Despite evidence showing the benefits of PPC, it is not used consistently in pediatric oncology care, particularly in the setting of early phase clinical trials. Including PPC experts is a proven way to improve access to specialty care for vulnerable populations. In this application, investigators propose a study to test the feasibility, acceptability, and potential impact of including PPC consultation for pediatric cancer patients and their families during their enrollment in phase 1 clinical trials.
详细描述
The proposed single-arm pilot study will use a prospective, longitudinal design conducted across three urban, tertiary care hospitals offering pediatric oncology phase 1 clinical trials (Phoenix Children's, St. Jude Children's Research Hospital, and the National Institutes of Health). These centers were chosen for their geographical diversity and variability in infrastructure and PPC resources to allow for generalizability of findings.
Aim 1: To assess the feasibility of integrating PPC consultation during eligibility screening for pediatric oncology patients enrolling in a phase 1 clinical trial.
Measures: Feasibility of the intervention (PPC consultation) will be assessed using the Feasibility of Intervention Measure (FIM), a high quality, 4-item implementation indicator, to be completed by caregivers of pediatric oncology patients (with or without patient, if patient aged ≥12 years) enrolling in phase 1 clinical trials and their respective oncologists. Additional measures will assess recruitment (total patients/caregivers screened, percent of patients/caregivers eligible to participate in the study, percent of patients/caregivers who assent/consent to study participation), and adherence (the proportion of study assessments completed, and the length of time required to complete study assessments).
Hypothesis: Integration of a PPC consultation at eligibility screening for pediatric oncology patients enrolling in a phase 1 clinical trial will be feasible, meeting the following targets: mean FIM score of ≥ 3 (coded 1-5) for > 50% of caregivers and oncology providers; enrollment: ≥ 70% of eligible patients/caregivers will assent/consent; adherence: ≥ 75% of enrolled participants will complete all PPC study assessments as planned. These target estimates are extrapolated from our preliminary work with this patient population.
Aim 2: To evaluate the acceptability of a PPC consultation with oncologists and caregivers of pediatric patients with cancer during phase 1 clinical trial enrollment.
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
- 0 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (aged 0-25 years) diagnosed with cancer and undergoing evaluation for enrollment in a phase 1 trial, their caregivers, as well as their primary treating oncologist are eligible for study participation.
排除标准
- •Previous palliative care exposure
研究组 & 干预措施
Pediatric Palliative Care Consultation
Formal PPC consultation will be completed by a subspeciality-trained PPC physician at each participating site for all study participants during the eligibility screening period for the phase 1 trial. Subsequent standard of care PPC follow-up visits will occur every 2-4 weeks to allow for variations in phase 1 trial structure.
干预措施: Pediatric Palliative Care Consultation (Behavioral)
结局指标
主要结局
Feasibility
时间窗: 2 years
Feasibility will be defined as a mean FIM score of ≥ 3 (coded 1-5) for \> 50% of caregivers and oncology providers; enrollment: ≥ 70% of eligible patients/caregivers will assent/consent; adherence: ≥ 75% of enrolled participants will complete all PPC study assessments as planned. Themes identified from qualitative findings, specifically from caregivers/patients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.
Acceptability
时间窗: two years
Acceptability will be defined as a mean AIM score of ≥ 3 (coded 1-5) for \> 70% of caregivers and oncology providers. Themes identified from qualitative findings, specifically from caregivers/patients' experiences with the PC team (either positive or negative) will be compared alongside quantitative data in a matrix to assess for overlap or variances in findings related to intervention feasibility, acceptability, and impact.
次要结局
- Barriers and Facilitators to Palliative Care Integration(two years)
- Impact on quality of life(two years)
研究者
Andrea Cuviello
Assistant Clinical Professor
Phoenix Children's Hospital