Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit
3 other identifiers
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jun 2025
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedStudy Start
First participant enrolled
June 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
May 6, 2026
May 1, 2026
2.4 years
May 6, 2025
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility of implementing the RIGHTimeCPV intervention
Quantitative findings of feasibility will be assessed using the Feasibility of Intervention Measure (FIM). The FIM measure includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score. Feasibility is standardly considered to be achieved with a mean score ≥3 for this measure. Higher scores indicate greater perceived feasibility of the intervention.
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
Quantitative findings of acceptability will be assessed using the Acceptability of Intervention Measure (AIM). The AIM measure includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score. Acceptability is standardly considered to be achieved with a mean score ≥3 for this measure. Higher scores indicate greater perceived acceptability.
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
The percentages of participating patients, parents, and multidisciplinary clinicians who engage in at least one cycle of the intervention.
6 months after the final DRV during study exit interviews [participant specific
Secondary Outcomes (2)
Potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding, and therapeutic alliance between patients/families and multidisciplinary clinicians
Between Day 1-30 after the CPV timepoint [participant specific], between Day 1-30 after the DRV timepoint [participant specific], and 6 months after the final DRV during study exit interviews [participant specific
Whether the practice of eliciting, sharing, and honoring individualized communication preferences is sustained by clinicians after participation in the RIGHTimeCPV intervention
6 months after the final DRV during study exit interviews [participant specific
Study Arms (3)
RIGHTimeCPV intervention: Patients and Caregivers (parents)
OTHERPediatric 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')
RIGHTimeCPV intervention: Psychosocial/nursing clinicians
OTHERPsychosocial/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
RIGHTimeCPV intervention: Pediatric oncologists
OTHERPediatric oncologists who treat participating patients/parents
Interventions
* 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.
* 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.
* CPC and oncologist discuss the CPV form * Oncologist, patient/parent, and CPC attend next disease re-evaluation visit together
Eligibility Criteria
You may qualify if:
- 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
- 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)
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erica C. Kaye, MD, MPH
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 29, 2025
Study Start
June 16, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.