Cancer Care Delivery in Adolescent and Young Adult Patients With Acute Lymphoblastic Leukemia

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Brief Title

Cancer Care Delivery in Adolescent and Young Adult Patients With Acute Lymphoblastic Leukemia

Official Title

Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)

Brief Summary

      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.
    

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.
    


Study Type

Observational


Primary Outcome

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


Condition

Acute Lymphoblastic Leukemia

Intervention

Medical Chart Review

Study Arms / Comparison Groups

 Observational (cancer care delivery analysis)
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

375

Start Date

December 18, 2017

Completion Date

December 30, 2020

Primary Completion Date

December 30, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

15 Years - 39 Years

Accepts Healthy Volunteers

No

Contacts

Julie A Wolfson, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT03204916

Organization ID

ACCL16N1CD

Secondary IDs

NCI-2017-01053

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Julie A Wolfson, Principal Investigator, Children's Oncology Group


Verification Date

October 2019