Recruiting

RIGHTimeCPV

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06993688

Conditions

Cancer

Communication

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Prognostic Communication-Patient/parent

Prognostic Communication-CPC

Prognostic Communication-Oncologist

Study Details

Brief summary:

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.

Conditions

Cancer

Communication

Study ID

NCT06993688

Start date

Jun 16, 2025

Status verified date

Aug, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Inclusion Criteria: Patients

  • Aged 12-25 years diagnosed with poor prognosis cancer (high risk or otherwise difficult to treat cancers), as defined by a pediatric oncologist estimating odds of overall survival as 50% or less
  • Anticipated by a pediatric oncologist to have one or more disease re-evaluation timepoints over the next six months
  • Not anticipated by a pediatric oncologist to approach end of life in the next three months

Inclusion Criteria: Parents/Caregivers

  • Aged 18 years or older and/or legally emancipated
  • Parent or other self-identified caregiver of a patient of any age with poor prognosis cancer (as defined above)

Inclusion Criteria: Oncologists

  • Pediatric oncologists who treat eligible patients/caregivers at the study site, St. Jude Children's Research Hospital (SJCRH) or its included affiliates:

  • Peoria, IL: The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic
  • Charlotte, NC: Novant Health Hemby Children's Hospital
  • Shreveport, LA: Ochsner LSU Health-Feist-Weiller Cancer Center

Inclusion Criteria: Communication Preferences Companions (CPCs)

  • Multidisciplinary clinicians from a participant's psychosocial or nursing care team, identified by that participant to serve as their 'communication preferences companion' (CPC) during the pilot
  • Provides clinical care to pediatric cancer patients under the auspices of psychology, social work, spiritual care, child life, cultural navigation, quality of life/palliative care, or nursing

Exclusion Criteria:

  • Does not meet the stated inclusion criteria

Study Design

Enrollment

85 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

Prognostic Communication-Patient/parent

  • 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

  • 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

  • CPC and oncologist discuss the CPV form
  • Oncologist, patient/parent, and CPC attend next disease re-evaluation visit together

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 ]
  • Acceptability 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 ]
  • Percentage of participants who engage in at least one cycle of intervention [ Time Frame: 6 months after the final DRV during study exit interviews [participant specific ]

Central Contacts and Locations

Central contacts

Erica C. Kaye, MD, MPH

866-278-5833referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Erica C. Kaye

866-278-5833referralinfo@stjude.org

Principal Investigator:

Erica C. Kaye, MD,MPH

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Prognostic Communication
  • Cancer
  • Poor Prognosis
  • Participants 12-25 years of age
  • Caregivers
  • Pediatric oncologists
  • Communication Preferences Companions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-08-17.