Acute Lymphoblastic Leukemia
Conditions
Brief summary
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.
Detailed description
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). V. To identify for AYAs with ALL, targetable structure- and process-level barriers and facilitators which will increase the proportion of patients having a documented treatment plan and receiving treatment according to NCCN guidelines. EXPLORATORY OBJECTIVE: I. To explore potential correlations with clinical and social demographic variables to the presence of a documented treatment plan and delivered treatment consistent with NCCN guidelines in AYAs with ALL. OUTLINE: CHART REVIEW: Patient medical record data is abstracted and treatment plans are reviewed for consistency to NCCN guidelines. For each patient, induction and post-induction care is recorded as either concordant with NCCN guidelines or non-concordant with NCCN guidelines. SITE QUESTIONNAIRE: Participating sites complete a questionnaire which is designed to capture facility-oriented data. FOCUS GROUPS: Healthcare providers participate in focus groups over 2-3 hours to discuss facilitators and barriers to AYA ALL guideline concordance. Participants provide responses which will be recorded on a flip-chart or white board, followed by discussion of the ideas for clarification.
Interventions
BEHAVIORALDiscussion
Participate in focus group
OTHERMedical Chart Review
Data abstraction and central review
OTHERQuestionnaire Administration
Complete questionnaire
Sponsors
National Cancer Institute (NCI)
Children's Oncology Group
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Overall evaluation window, an average of 12 weeks after start of treatment | Primary analysis will describe the proportion of patients meeting this endpoint in overall evaluation window. |
| 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 | An average of 12 weeks after start of treatment | Primary analysis will describe the proportion of patients meeting this endpoint. |
| 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) | 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 with induction and post-induction therapy delivered consistent with the National Comprehensive Cancer Network guidelines based upon primary physician type and facility type groups | 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 | 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. |
Countries
Puerto Rico, United States
Outcome results
None listed