Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

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Eligibility 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)

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

694

Study ID:

NCT02847130

Recruitment Status:

Active, not recruiting

Sponsor:

Children's Oncology Group

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There are 32 Locations for this study

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Kaiser Permanente-Oakland
Oakland California, 94611, United States
Alfred I duPont Hospital for Children
Wilmington Delaware, 19803, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville Florida, 32207, United States
Nemours Children's Hospital
Orlando Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola Florida, 32504, United States
Tampa General Hospital
Tampa Florida, 33606, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa Florida, 33607, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Blank Children's Hospital
Des Moines Iowa, 50309, United States
Children's Hospital New Orleans
New Orleans Louisiana, 70118, United States
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas Nevada, 89144, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States
BI-LO Charities Children's Cancer Center
Greenville South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
Dell Children's Medical Center of Central Texas
Austin Texas, 78723, United States
Driscoll Children's Hospital
Corpus Christi Texas, 78411, United States
Methodist Children's Hospital of South Texas
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Mary Bridge Children's Hospital and Health Center
Tacoma Washington, 98405, United States
San Jorge Children's Hospital
San Juan , 00912, Puerto Rico
University Pediatric Hospital
San Juan , 00926, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

694

Study ID:

NCT02847130

Recruitment Status:

Active, not recruiting

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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