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

Sponsor

St. Jude Children's Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05116566

Collaborator

(none)

Enrollment

Location

29.5

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Cancer Communication

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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 18, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Prognostic Communication Preferences [Within 60 days of enrolment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Legal caregivers 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).
Parents may consist of a married biological mother and father, a biological parent and his/her male or female significant other, or a single biological parent.
English-speaking

Oncologists