Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in… (NCT02847130) | Clinical Trial Compass
CompletedNot Applicable
Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology
United States, Puerto Rico530 participantsStarted 2016-11-21
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
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
4
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
5
Key coding categories (Aim 2)
Timeframe: Data collected from March 28, 2017 through October 15, 2018 will be evaluated
6
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