Clinical trial NCT02847130: Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology
Official title: Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: Clinical practice guidelines
supportive care
pediatrics
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-07-28
Enrollment: 530
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

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.

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)

Primary outcomes:
measure: The proportion of clinical practice guidelines (CPG)-consistent care of fever and neutropenia (FN) episodes
timeFrame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
measure: The proportion of CPG-consistent care of chemotherapy induced nausea and vomiting (CINV) episodes
timeFrame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
measure: The proportion of CPG-consistent care of fertility preservation (FP) episodes
timeFrame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
measure: Possible influence of National Cancer Institute Community Oncology Research Program site size (Aim 1a)
timeFrame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
measure: Key coding categories (Aim 2)
timeFrame: Data collected from March 28, 2017 through October 15, 2018 will be evaluated
measure: CPG format which is well understood by pediatric oncology healthcare providers (Aim 3)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Wilmington
country: United States
facility: Alfred I duPont Hospital for Children
state: Delaware
city: Fort Myers
country: United States
facility: Golisano Children's Hospital of Southwest Florida
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital/Joe DiMaggio Children's Hospital
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic-Jacksonville
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Pensacola
country: United States
facility: Nemours Children's Clinic - Pensacola
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Saint Joseph's Hospital/Children's Hospital-Tampa
state: Florida
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Des Moines
country: United States
facility: Blank Children's Hospital
state: Iowa
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center Jefferson
state: Louisiana
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital at Spectrum Health
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation
state: Nevada
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
city: New York
country: United States
facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
state: New York
city: Fargo
country: United States
facility: Sanford Broadway Medical Center
state: North Dakota
city: Greenville
country: United States
facility: BI-LO Charities Children's Cancer Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center - Sioux Falls
state: South Dakota
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Children's Hospital of South Texas
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Tacoma
country: United States
facility: Mary Bridge Children's Hospital and Health Center
state: Washington
city: San Juan
country: Puerto Rico
facility: San Jorge Children's Hospital
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Children's Oncology Group
name: L. Lee Dupuis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sugalski AJ, Lo T, Beauchemin M, Grimes AC, Robinson PD, Walsh AM, Santesso N, Dang H, Fisher BT, Wrightson AR, Yu LC, Sung L, Dupuis LL. Facilitators and barriers to clinical practice guideline-consistent supportive care at pediatric oncology institutions: a Children's Oncology Group study. Implement Sci Commun. 2021 Sep 16;2(1):106. doi: 10.1186/s43058-021-00200-2.