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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 : Recruiting
First Posted : July 2, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia 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.

SECONDARY 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 1-2 hours to discuss facilitators and barriers to AYA ALL guideline concordance. Participants provide responses via electronic handheld technology in order to maintain anonymity followed by discussion of the ideas for clarification.


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Study Type : Observational
Estimated Enrollment : 318 participants
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
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021


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 1-2 hours to discuss facilitators and barriers to AYA ALL guideline concordance. Participants provide responses via electronic handheld technology in order to maintain anonymity followed by discussion of the ideas for clarification.

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

Other: Questionnaire Administration
Ancillary studies




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: Up to 4 years ]
    Univariate descriptive statistics will be used to determine the proportion of patients with documented guideline-consistent care in each evaluation window (overall, induction, and post-induction therapy [PIT]). Primary analysis will describe the proportion of patients meeting this endpoint. Generalized linear mixed models which treat institution as random effects will be used to estimate the proportion of patients who have documented guideline-consistent care and the corresponding confidence intervals accounting for the correlation of outcome within institution.

  2. 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: Up to 4 years ]
    Univariate descriptive statistics will be used to determine the proportion of patients with delivery of guideline-consistent care during induction and the first two months of post-induction therapy (overall, induction and PIT). Primary analysis will describe the proportion of patients meeting this endpoint. Generalized linear mixed models which treat institution as random effects will be used to estimate the proportion of patients who are delivered guideline-consistent care and the corresponding confidence intervals accounting for the correlation of outcome within institution.

  3. 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: Up to 4 years ]
    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). Analyses will be conducted stratified by age and overall.

  4. Proportion of patients with induction and post-induction therapy delivered according to guidelines based upon primary physician type (pediatric oncology versus other) and facility type groups (children?s hospital versus other) [ Time Frame: Up to 4 years ]
    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). Analyses will be conducted stratified by age and overall.

  5. Facilitators and barriers to National Comprehensive Cancer Network guidelines for adolescent and young adults with acute lymphoblastic leukemia [ Time Frame: Up to 4 years ]
    Will be descriptive in nature and employ thematic analysis. After each focus group, notes made during the sessions will be analyzed using a directed content analysis. Barriers and facilitators will be categorized in terms of applicability to facets of structure or process within healthcare delivery, and along the lines of the conceptual model. New categories and subcategories will be used to code concepts that do not fall within pre-determined categories. Themes of commonality will be sought especially within newly developed categories outside of the conceptual framework. These barriers and facilitators will be described.



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:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescent and Young Adult (AYA) patients with Acute Lymphoblastic Leukemia (ALL)
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 3a: 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

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


  Show 445 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Julie Wolfson Children's Oncology Group

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT03204916     History of Changes
Other Study ID Numbers: ACCL16N1CD
NCI-2017-01053 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACCL16N1CD ( Other Identifier: Childrens 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: April 16, 2019
Last Verified: March 2019

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