Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorSt. Jude Children's Research Hospital
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Does not meet the stated inclusion criteria
Trial design
Design model
Parallel
Treatments tested in this trial
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
Treatment groups
85 Participants
are divided into 3 treatment groupsGroup A: RIGHTimeCPV intervention: Patients and Caregivers (parents)Other 1 intervention
Group B: RIGHTimeCPV intervention: Psychosocial/nursing cliniciansOther 1 intervention
Group C: RIGHTimeCPV intervention: Pediatric oncologistsOther 1 intervention
Trial outcomes
Primary outcomes
1
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 specific2
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 specific3
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 specificSecondary outcomes
1
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 specific2
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 specificSponsors and contacts
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St. Jude Children's Research Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov