Purpose

This research trial studies 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.

Condition

Eligibility

Eligible Ages
Between 15 Years and 39 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Newly diagnosed with either Ph- or Ph+ ALL between January 1st, 2012 and December 31st, 2016
  • 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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational (cancer care delivery analysis) 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
  • Other: Medical Chart Review
    Data abstraction and central review
    Other names:
    • Chart Review
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
aaraiza@montefiore.org

More Details

NCT ID
NCT03204916
Status
Recruiting
Sponsor
Children's Oncology Group

Study Contact

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 OBJECTIVES:

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.