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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02847130
Other study ID # ACCL15N1CD
Secondary ID NCI-2016-00980AC
Status Completed
Phase
First received
Last updated
Start date November 21, 2016
Est. completion date June 30, 2023

Study information

Verified date April 2023
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 530
Est. completion date June 30, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Informational Intervention
Participate in focus group
Interview
Undergo one-on-one interviews
Medical Chart Review
Review of medical chart
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
Puerto Rico San Jorge Children's Hospital San Juan
Puerto Rico University Pediatric Hospital San Juan
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Dell Children's Medical Center of Central Texas Austin Texas
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Driscoll Children's Hospital Corpus Christi Texas
United States Blank Children's Hospital Des Moines Iowa
United States Sanford Broadway Medical Center Fargo North Dakota
United States Golisano Children's Hospital of Southwest Florida Fort Myers Florida
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States BI-LO Charities Children's Cancer Center Greenville South Carolina
United States Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Nemours Children's Clinic-Jacksonville Jacksonville Florida
United States Bronson Methodist Hospital Kalamazoo Michigan
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Children's Hospital New Orleans New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Kaiser Permanente-Oakland Oakland California
United States Nemours Children's Hospital Orlando Florida
United States Nemours Children's Clinic - Pensacola Pensacola Florida
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Mary Bridge Children's Hospital and Health Center Tacoma Washington
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Tampa General Hospital Tampa Florida
United States Alfred I duPont Hospital for Children Wilmington Delaware

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of clinical practice guidelines (CPG)-consistent care of fever and neutropenia (FN) episodes 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. Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Primary The proportion of CPG-consistent care of chemotherapy induced nausea and vomiting (CINV) episodes 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). Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Primary The proportion of CPG-consistent care of fertility preservation (FP) episodes 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. Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Primary Possible influence of National Cancer Institute Community Oncology Research Program site size (Aim 1a) Will be estimated and examined as fixed effect covariates in these generalized linear mixed effect models described above. Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Primary Key coding categories (Aim 2) 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. Data collected from March 28, 2017 through October 15, 2018 will be evaluated
Primary CPG format which is well understood by pediatric oncology healthcare providers (Aim 3) 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. 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
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