Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 480
- 主要终点
- Proportion of patients with a documented treatment plan consistent with the National Comprehensive Cancer Network guidelines based upon primary physician type (pediatric oncology versus other) and facility type groups (children's hospital versus other)
研究概览
简要总结
This study investigates cancer care delivery in adolescent and young adult patients with acute lymphoblastic leukemia. Surveying institutions, evaluating delivery of care at the patient level and seeking input from healthcare providers may help doctors increase rates of adherence to National Comprehensive Cancer Network (NCCN) treatment guidelines. It may also improve care for adolescent and young adult patients with acute lymphoblastic leukemia.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the proportion of adolescent and young adult (AYA) acute lymphoblastic leukemia (ALL) patients with a documented treatment plan consistent with NCCN guidelines for AYAs with ALL.
II. To evaluate the proportion of AYA ALL patients whose delivered treatment during induction and post-induction therapy (PIT) is consistent with NCCN guidelines for AYAs with ALL.
III. To determine the impact of treating physician specialty and facility type on likelihood of AYA ALL patients having a documented treatment plan concordant with NCCN guidelines when stratified by age group (15-17year[y], 18-21y, and 22-39y).
IV. To determine the impact of treating physician specialty and facility type on the likelihood of AYA ALL patients receiving induction and post-Induction therapy (PIT) concordant with NCCN guidelines when stratified by age group (15-17y, 18-21y, and 22-39y).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed with either Ph- or Ph+ ALL between January 1st, 2012 and December 31st, 2016
- •Age at diagnosis: 15-39 years, inclusive
- •Both diagnosed and initially treated at the participating National Cancer Institute Community Oncology Research Program (NCORP) institution during induction and post-induction therapy (PIT)
- •Aim 3: Healthcare professional currently employed at a participating NCORP institution
- •Eligible healthcare providers include but are not limited to: physicians, registered nurses (RNs), nurse practitioners, physician assistants, patient advocates, social workers, pharmacists and clinical research associates (CRAs)
- •Aim 3: Direct involvement in the care of AYA ALL patients
排除标准
- •Diagnosis of secondary ALL
- •Diagnosis of mixed lineage acute leukemia
- •Diagnosis of acute leukemia of ambiguous lineage (ALAL)
- •Diagnosis of Burkitt's leukemia
- •Transfer of care to another institution during induction or post-induction therapy (PIT)
- •Aim 3: Trainee
结局指标
主要结局
Proportion of patients with a documented treatment plan consistent with the National Comprehensive Cancer Network guidelines based upon primary physician type (pediatric oncology versus other) and facility type groups (children's hospital versus other)
时间窗: An average of 12 weeks after start of treatment
Descriptive analysis will be used to examine the differences in the proportion of patients with a documented treatment plan consistent with the NCCN guidelines and with induction and post-induction therapy delivered according to guidelines, between primary physician type (pediatric oncology vs. other) and facility type groups (children's hospital \[CH\] vs. other).
Proportion of patients whose delivered treatment in induction and two months of post-induction phase chemotherapy is consistent with National Comprehensive Cancer Network guidelines for adolescents and young adults with acute lymphoblastic leukemia
时间窗: An average of 12 weeks after start of treatment
Primary analysis will describe the proportion of patients meeting this endpoint.
Proportion of patients with induction and post-induction therapy delivered consistent with the National Comprehensive Cancer Network guidelines based upon primary physician type and facility type groups
时间窗: An average of 12 weeks after start of treatment
Descriptive analysis will be used to examine the differences in the proportion of patients with a documented treatment plan consistent with the NCCN guidelines and with induction and post-induction therapy delivered according to guidelines, between primary physician type (pediatric oncology vs. other) and facility type groups (CH vs. other).
Facilitators and barriers ranked by importance to National Comprehensive Cancer Network guidelines for adolescent and young adults with acute lymphoblastic leukemia
时间窗: Up to 6 focus groups, assessed up to 4 years
These endpoints will be defined by the issues and language used by the participants during the focus groups. Will be descriptive in nature and employ thematic analysis.
Proportion of patients with a documented treatment plan concordant with National Comprehensive Cancer Network (NCCN) guidelines for adolescent and young adults with acute lymphoblastic leukemia
时间窗: PIT evaluation window, an average of 8 weeks after induction
Primary analysis will describe the proportion of patients in post-induction therapy (PIT) evaluation window.
次要结局
未报告次要终点