An interventional study of Prognostic Communication-Patient/parent and Prognostic Communication-CPC in Cancer and Communication, sponsored by St. Jude Children's Research Hospital. Recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Other
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
Secondary Objectives
An estimated range of 52-85 total participants across all subject cohorts at St. Jude and participating affiliate sites, including 12-15 pediatric oncologists, 2-3 family units per participating oncologist (with an emphasis on dyadic recruitment within a given family unit, but also may include independent patients, independent caregivers, or a patient and multiple caregivers; estimated 15-25 patients and 15-25 parents), and 10-20 'communication preferences companions' (CPCs).
The RIGHTimeCPV intervention centers eliciting, sharing, and integrating individualized patient/parent preferences for prognostic communication into routine clinical practice through collaboration between multidisciplinary clinicians on the care team.
The intervention comprises five parts: 1) patient/parent identifies and selects a CPC; 2) CPC reviews intervention materials and conversation guide with the research team; 3) CPC and patient/parent meet for a CPV visit, and CPC documents patient/parent preferences in a templated form; 4) CPC and oncologist discuss the CPV form; 5) oncologist, patient/parent, and CPC attend next disease re-evaluation visit together.
Data will be collected at the following timepoints: 1) study enrollment (routine demographic information collected from each participant); 2) CPV 'conversation guide' training with CPC and research staff (audio-recorded encounter); 3) CPV with patient/parent and CPC (audio-recorded encounter); 4) during the period after a CPV and before the next disease re-evaluation encounter (brief survey and semi-structured interview for patients/parents and oncologists); 5) CPC-oncologist discussion to review the CPV form (email or audio-recorded encounter); 6) disease re-evaluation visit with patient/parent, oncologist, and CPC (audio-recorded encounter); 7) post-intervention interview (brief surveys for patients/parents and oncologists and semi-structured interviews for all participants); and 8) post-intervention interview six months after the final DRV (semi-structured interviews for all participants).
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 85 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients
Inclusion Criteria: Parents/Caregivers
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:
Inclusion Criteria: Communication Preferences Companions (CPCs)
Exclusion Criteria:
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')
Behavioral: Prognostic Communication-Patient/parent
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
Behavioral: Prognostic Communication-CPC
Pediatric oncologists who treat participating patients/parents
Behavioral: Prognostic Communication-Oncologist
* 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
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.
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
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.
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
The percentages of participating patients, parents, and multidisciplinary clinicians who engage in at least one cycle of the intervention.
Time frame: 6 months after the final DRV during study exit interviews [participant specific
Potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding, and therapeutic alliance between patients/families and multidisciplinary clinicians
This outcome will be assessed through generation of qualitative thematic findings. Specifically, qualitative data gathered from audio-recorded encounters at the Communication Preferences Visit (CPV) and DRV timepoints, as well as post-intervention interviews, will undergo rapid qualitative analysis and reflexive thematic analysis to explore participating patient, caregiver, and clinician impressions of the intervention's impact on communication quality, prognostic understanding, and therapeutic alliance between patients/caregivers and multidisciplinary clinicians.
Time frame: 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
Through analysis of the final post-intervention interview, the investigators will generate thematic findings related to participant perspectives on the intervention's impact on individual attitudes and behaviors and whether the practice of eliciting, sharing, and honoring individualized communication preferences was sustained by clinicians after participation in the RIGHTimeCPV intervention.
Time frame: 6 months after the final DRV during study exit interviews [participant specific
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
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