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

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ClinicalTrials.gov Identifier: NCT03204916
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : January 26, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Behavioral: Discussion Other: Medical Chart Review Other: Questionnaire Administration

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 Design
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Study Type : Observational
Actual Enrollment : 301 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult (AYA) Acute Lymphoblastic Leukemia (ALL)
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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

 Behavioral: Discussion
Participate in focus group
Other Name: Discuss

Other: Medical Chart Review
Data abstraction and central review
Other Name: Chart Review

Other: Questionnaire Administration
Complete questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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.

  2. 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 [ Time Frame: Induction evaluation window, an average of 4 weeks after start of treatment ]
    Primary analysis will describe the proportion of patients meeting this endpoint in induction evaluation window.

  3. 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 [ Time Frame: 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.

  4. 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 [ Time Frame: An average of 12 weeks after start of treatment ]
    Primary analysis will describe the proportion of patients meeting this endpoint.

  5. 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) [ Time Frame: 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).

  6. 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 [ Time Frame: 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).

  7. Facilitators and barriers ranked by importance to National Comprehensive Cancer Network guidelines for adolescent and young adults with acute lymphoblastic leukemia [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthcare professional currently employed at a participating NCORP institution, and patients diagnosed with Philadelphia chromosome (Ph) negative or positive ALL between January 1, 2012 and December 31, 2016.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204916


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Julie A Wolfson Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT03204916    
Other Study ID Numbers: ACCL16N1CD
NCI-2017-01053 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACCL16N1CD ( Other Identifier: Children's Oncology Group )
COG-ACCL16N1CD ( Other Identifier: DCP )
ACCL16N1CD ( Other Identifier: CTEP )
UG1CA189955 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases