Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06993688
Status
Recruiting
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Conditions

  • Cancer
  • Communication

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Prognostic Communication-Patient/parent — BEHAVIORAL
    * Patient/parent identifies and selects a communication preferences companion (CPC) * CPC and patient/parent meet for a Communication Preferences Visit (CPV) * Oncologist, patient/parent, and CPC attend next disease re-evaluation visit together.
  • Prognostic Communication-CPC — BEHAVIORAL
    * CPC reviews intervention materials and conversation guide with the research team * CPC and patient/parent meet for a CPV, and CPC documents patient/parent preferences in a templated form * CPC and oncologist discuss the CPV form * Oncologist, patient/parent, and CPC attend next disease re-evaluation visit together.
  • Prognostic Communication-Oncologist — BEHAVIORAL
    * CPC and oncologist discuss the CPV form * Oncologist, patient/parent, and CPC attend next disease re-evaluation visit together

Study Details

The purpose of this research study is to obtain insights and feedback from patients and parents about a new approach to support conversations about how cancer may affect one's future life and quality of life (i.e., prognostic communication). This study involves creating a personalized approach to discussing prognosis. Primary Objectives * To evaluate the feasibility of implementing the RIGHTimeCPV intervention among pediatric oncology patients, caregivers, and clinicians (referred to herein as "shareholders"). * To assess the acceptability of the intervention across the shareholder groups. Secondary Objectives * To explore the potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding, and therapeutic alliance between patients/families and multidisciplinary clinicians. * To explore whether the practice of eliciting, sharing, and honoring individualized communication preferences is sustained by clinicians after participation in the RIGHTimeCPV intervention.

Key Dates

Start date
Jun 16, 2025
Status verified
May 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
85 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: RIGHTimeCPV intervention: Patients and Caregivers (parents)
    Pediatric patients aged 12-25 years with poor prognosis cancer who receive treatment at the study site or participating affiliate Caregivers of patients of any age who receive treatment at the study site (referred to as 'parent')
  • Other: RIGHTimeCPV intervention: Psychosocial/nursing clinicians
    Psychosocial/nursing clinicians who participate in the clinical care of participating patients/parents and serve as communication preferences companions (CPCs) under the auspices of this study
  • Other: RIGHTimeCPV intervention: Pediatric oncologists
    Pediatric oncologists who treat participating patients/parents

Primary Outcome Measure

Feasibility of implementing the RIGHTimeCPV intervention [ Time Frame: Between Day 1-30 after a Disease Reevaluation Visit (DRV) [participant specific] and again 6 months after the final DRV during study exit interviews [participant specific ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Erica C. Kaye
[email protected]
866-278-5833
Erica C. Kaye, MD,MPH (PRINCIPAL_INVESTIGATOR)

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