- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05116566
Revealing Information Genuinely & Honestly Across Time: Pediatric Oncology Stakeholder Preferences and Recommendations for Prognostic Communication
This study is being conducted to better understand the preferences and recommendations of patients and parents regarding optimal ways to share prognostic communication. Specifically, to learn what stakeholders (i.e., patients, parents, and doctors) believe to be the "right" content, timing, and delivery of this important information.
Specific Aim 1
- To define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement.
Specific Aim 2
- To engage stakeholders in the design of a patient/parent centered RIGHTime framework and communication intervention to promote individualized, timely prognostic disclosure.
Study Overview
Status
Conditions
Detailed Description
This study will have two phases.
Phase 1:
Investigators will define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement. Eligible parents and patients will participate in semi-structured interviews on prognostic communication preferences, stratified by cohort: poor-prognosis diagnosis, advancing disease, phase I/II trial enrollment, and bereavement; eligible oncologists will complete interviews on prognostic disclosure preferences. Participants will participate in a single interview that will last anywhere from 30 to 60 minutes.The interview will be audio-recorded and transcribed. Participant demographic and social determinants of health information will be collected.
Phase 2:
Investigators will partner with a smaller group of stakeholders (parents, patients, and oncologist) from phase 1 to develop a clinical communication guide to help improve communication between patients, families, and cancer doctors. The panel will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Erica C. Kaye, MD, MPH
- Phone Number: 866-278-5833
- Email: referralinfo@stjude.org
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- Recruiting
- St. Jude Children's Research Hospital
-
Contact:
- Erica C. Kaye, MD, MPH
- Phone Number: 866-278-5833
- Email: referralinfo@stjude.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients
- Aged 12-25 years
- Recent diagnosis (< 3 months) of a poor prognosis cancer with an estimated survival of 50% or less by the primary oncologist (cohort 1) OR recent history of disease relapse/progression within the past 3 months (cohort 2) OR active enrollment on a phase I/II trial (cohort 3).
- English-speaking
Parents
- Aged 18 years or older
- Parent (or legal caregiver) of a child with cancer of any age who meets the above criteria for cohorts 1-3 OR of a child who died from cancer 6-24 months from enrollment (cohort 4).
- English-speaking
Oncologists
- Pediatric oncologists who treat patients at SJCRH or who refer patients for treatment to SJCRH
Exclusion Criteria:
- Does not meet the inclusion criteria.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Patients
Three distinct sub-cohorts will be targeted for recruitment to represent perspectives across the advancing illness course: patients ≤3 months from a poor- prognosis diagnosis (cohort 1), patients ≤ 3 months from disease relapse or progression (cohort 2), and patients actively enrolled on a phase I/II trials (cohort 3).For cohorts 1-3, patient-parent dyads will be enrolled when eligible; however, an independent patient is eligible for enrollment if the parent consents for the patient's enrollment but declines his/her own enrollment.
|
Parents
Four distinct sub-cohorts of parents will be targeted for recruitment, including cohorts 1-3 and a fourth bereavement cohort.
For cohorts 1-3, patient-parent dyads will be enrolled when eligible; however, an independent parent is eligible for enrollment if the patient declines enrollment, but the parent wishes to participate.
|
Oncologist
Pediatric oncologists who treat or refer patients for treatment at St. Jude Children's Research Hospital (SJCRH) will be eligible to participate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variables influencing stakeholder preferences
Time Frame: After completion of all interviews; 4 sessions over a period of approximately 1-2 years
|
We will use a participatory design approach with user-centered design methods, we will convene a Stakeholder Panel comprising patients, parents, oncologists, and researchers that will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.
|
After completion of all interviews; 4 sessions over a period of approximately 1-2 years
|
Prognostic Communication Preferences
Time Frame: Within 60 days of enrollment
|
We will use the rapid analysis (RA) qualitative approach for analysis of interview transcripts methods to define patient, parent, and oncologist preferences and recommendations with respect to timing, content, and delivery of prognostic communication at varying timepoints across the advancing illness course.
|
Within 60 days of enrollment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Erica C. Kaye, MD, MPH, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RIGHTime
- NCI-2021-12350 (Registry Identifier: NCI Clinical Trial Registration Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Communication
-
Insel Gruppe AG, University Hospital BernSwiss National Science Foundation; University of Bern; Fachhochschule NordwestschweizRecruitingCommunication Research | Communication, MultidisciplinarySwitzerland
-
Johns Hopkins UniversityCompletedCommunication | Obstetric Complication | High Risk Pregnancy | Multidisciplinary CommunicationUnited States
-
Dartmouth-Hitchcock Medical CenterAmerican Cancer Society, Inc.CompletedCommunicationUnited States
-
Stanford UniversityUniversity of Southern CaliforniaActive, not recruitingCommunicationUnited States
-
National Taiwan University HospitalCompleted
-
Boston Children's HospitalPatient-Centered Outcomes Research InstituteCompletedCommunicationUnited States, Canada
-
Medical College of WisconsinCompletedCommunicationUnited States
-
University of Wisconsin, MadisonPatient-Centered Outcomes Research Institute; Brigham and Women's Hospital; Oregon... and other collaboratorsCompleted
-
University of Southern CaliforniaSoar Technology; Creative Media and Behavioral Health Center; USC Center for...CompletedCommunicationUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoPatient-Centered Outcomes Research InstituteCompleted