Revealing Information Genuinely & Honestly Across Time: Pediatric Oncology Stakeholder Preferences and Recommendations for Prognostic Communication

Completed

• Conditions: Communication; Pediatric Cancer

• Registration Number: NCT05116566
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Study Start: 2022-06-18
• Primary Completion: 2024-08-14
• Study Completion: 2024-08-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic Communication Preferences	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.
Variables influencing stakeholder preferences	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.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States