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Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02847130
Recruitment Status : Active, not recruiting
First Posted : July 28, 2016
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:
This research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require support by healthcare providers. By reviewing patients' medical chart records, meeting in focus groups and in one-on-one interviews, healthcare providers may improve how clinical practice guidelines are used to support children undergoing cancer treatment.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia B-Cell Non-Hodgkin Lymphoma Childhood Acute Myeloid Leukemia Childhood Burkitt Lymphoma Childhood Neoplasm Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Recurrent Childhood Acute Lymphoblastic Leukemia Other: Informational Intervention Other: Interview Other: Medical Chart Review Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. To measure the rate of adherence to selected Children's Oncology Group (COG)-endorsed supportive care clinical practice guidelines (CPG) recommendations at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) sites. (Aim 1) II. To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. (Aim 1a) III. To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care. (Aim 1b) IV. To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. (Aim 2) V. To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. (Aim 3)

OUTLINE:

AIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia [FN], chemotherapy induced nausea and vomiting [CINV], fertility preservation [FP]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs.

AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed.

AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing.

Study Design
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Study Type : Observational
Estimated Enrollment : 694 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric Oncology
Actual Study Start Date : November 21, 2016
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (chart review, focus group, interviews)

AIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia [FN], chemotherapy induced nausea and vomiting [CINV], fertility preservation [FP]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs.

AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed.

AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing.

 Other: Informational Intervention
Participate in focus group

Other: Interview
Undergo one-on-one interviews

Other: Medical Chart Review
Review of medical chart

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of clinical practice guidelines (CPG)-consistent care of fever and neutropenia (FN) episodes [ Time Frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated ]
    FN will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent versus (vs.) CPG inconsistent care for each FN episode.

  2. The proportion of CPG-consistent care of chemotherapy induced nausea and vomiting (CINV) episodes [ Time Frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated ]
    CINV will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each CINV episode (separately for high and moderate emetogenicity risk chemotherapy).

  3. The proportion of CPG-consistent care of fertility preservation (FP) episodes [ Time Frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated ]
    FP will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each FP episode.

  4. Possible influence of National Cancer Institute Community Oncology Research Program site size (Aim 1a) [ Time Frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated ]
    Will be estimated and examined as fixed effect covariates in these generalized linear mixed effect models described above.

  5. Key coding categories (Aim 2) [ Time Frame: Data collected from March 28, 2017 through October 15, 2018 will be evaluated ]
    Will be identified by the Framework for Clinical Practice Guideline Implementability. Operational definitions of each category will be determined. The implementation barriers and facilitators identified by focus group members will be coded using these categories independently by two investigators. New categories and sub-categories will be used to code concepts that do not fall within the pre-determined categories. Themes of commonality will be sought especially within the newly developed categories that fall outside the framework adapted from Gagliardi et al. Facilitators of and barriers to CPG implementation will be described.

  6. CPG format which is well understood by pediatric oncology healthcare providers (Aim 3) [ Time Frame: Data collected from a minimum of 25 interviews starting from February 1, 2019 to the timepoint where a format that is well understood by participants is developed will be evaluated ]
    The issues identified via the interviews, changes made to the formatting, and rationale for the changes will be documented between each round in a tracking matrix. The proportion of interviewees who select the correct course of action when presented with four possible courses of action will be described for each iteration of the CPG format including the final version. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.


Eligibility Criteria
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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients < 21 years old at cancer diagnosis who received care as an inpatient or outpatient at a participating COG NCORP site between January 1, 2014 and December 31, 2015
Criteria

Inclusion Criteria:

  • Site willingness to participate in all 3 aims
  • AIM 1 - ELIGIBILITY CRITERIA FOR INCLUSION IN RETROSPECTIVE CENTRALIZED CHART REVIEW
  • Received care as an inpatient or outpatient at a participating COG NCORP site during the time period between January 1, 2014 and December 31, 2015
  • Ever enrolled on any COG trial (episode does not have to occur while on trial and the COG trial may be therapeutic or non-therapeutic)
  • Has at least one episode eligible for FN, CINV or FP review
  • CPG-Specific Eligibility

  • FN

    • Has any of the following diagnoses:

      • Newly diagnosed acute lymphoblastic leukemia
      • Relapsed acute lymphoblastic leukemia
      • Any acute myeloid leukemia
      • Burkitt's or mature B cell non-Hodgkin's lymphoma
      • Any myeloablative autologous or allogeneic hematopoietic stem cell transplantation
      • Developed FN at least once

  • CINV

    • Diagnosis of cancer
    • Received moderately emetogenic chemotherapy as an inpatient
    • < 12 years of age at the start of a CINV episode and received highly emetogenic chemotherapy as an in-patient

  • FP

    • Newly diagnosed cancer
    • >= 15 years of age at cancer diagnosis
  • Note: a single patient may contribute data for multiple episodes
  • AIM 2 AND AIM 3 INCLUSION CRITERIA

  • Healthcare professional currently employed at a participating COG NCORP institution

    • Eligible healthcare providers include but are not limited to: physicians, nurses, nurse practitioners, pharmacists, social workers, dieticians, psychologists, and physical therapists/physiotherapists
  • Provides direct care for children with cancer as part of current position at NCORP site

Exclusion Criteria:

  • AIM 2 AND AIM 3 EXCLUSION CRITERIA
  • Trainees are excluded
  • Previous participation in this study either for Aim 2 or Aim 3
  • Each health care provider can only be involved in one event (focus group or interview)
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): NCT02847130


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: L. Lee Dupuis Children's Oncology Group
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT02847130    
Other Study ID Numbers: ACCL15N1CD
NCI-2016-00980 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACCL15N1CD ( Other Identifier: Children's Oncology Group )
COG-ACCL15N1CD ( Other Identifier: DCP )
ACCL15N1CD ( Other Identifier: CTEP )
UG1CA189955 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: September 2021
Keywords provided by Children's Oncology Group:
Clinical practice guidelines
supportive care
pediatrics
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Leukemia
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections