Prognostic Communication for Cancer

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Not meeting inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Erica C. Kaye, MD, MPH

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for pediatric oncology patients, their caregivers, and clinicians. It aims to gather feedback on a new method of discussing cancer prognosis. Participants must be involved in the care of young cancer patients.

Inclusion Criteria

Patients not anticipated by a pediatric oncologist to approach end of life in the next three months

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

I am aged 12-25 with a cancer that has a low chance of survival.

Exclusion Criteria

Does not meet the stated inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the RIGHTimeCPV intervention, which includes identifying a communication preferences companion (CPC), reviewing intervention materials, and participating in a Communication Preferences Visit (CPV).

4-6 weeks

Multiple visits including CPV and disease re-evaluation visits

Follow-up

Participants are monitored for the impact of the intervention on communication quality and therapeutic alliance, with data collected at various timepoints including post-intervention interviews.

6 months

Post-intervention interviews and surveys

Treatment Details

Interventions

• RIGHTimeCPV intervention

Trial Overview The study tests the RIGHTimeCPV intervention, which is a personalized approach to prognostic communication in pediatric oncology. It evaluates feasibility, acceptability among stakeholders, and its potential impact on communication quality.

Participant Groups

Group I: RIGHTimeCPV intervention: Psychosocial/nursing clinicians Experimental Treatment 1 Intervention

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

Group II: RIGHTimeCPV intervention: Pediatric oncologists Experimental Treatment 1 Intervention

Pediatric oncologists who treat participating patients/parents

Group III: RIGHTimeCPV intervention: Patients and Caregivers (parents) Experimental Treatment 1 Intervention

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')

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+