Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT06993688

Recrutement en cours

Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit

Interventionnel

Phase non listée

St. Jude Children's Research Hospital

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.

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Catégorie de traitement

Comportemental

Mutations requises

Aucun

Essai commencé

2025-06-16

Dernière mise à jour par le sponsor

2025-09-22

Achèvement estimé

2027-11-01

Éligibilité

Critères d'inclusion

* 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

Critères d'exclusion

Aucun

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Détails de la conception

AllocationNon-Randomized

Modèle d'interventionParallel Assignment

MasquageNone (Open Label)

Nombre à inscrire80

Bras et interventions

Bras

Interventions

Type : Other

Description : 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')

Interventions :

Prognostic Communication-Patient/parent
Prognostic Communication-CPC
Prognostic Communication-Oncologist

Mesures des résultats

Mesures des résultats primaires

Feasibility of implementing the RIGHTimeCPV interventionBetween 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

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.

Acceptability of implementing the RIGHTimeCPV interventionBetween 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

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.

Percentage of participants who engage in at least one cycle of intervention6 months after the final DRV during study exit interviews [participant specific

The percentages of participating patients, parents, and multidisciplinary clinicians who engage in at least one cycle of the intervention.

Mesures des résultats secondaires

Potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding, and therapeutic alliance between patients/families and multidisciplinary cliniciansBetween 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

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.

Whether the practice of eliciting, sharing, and honoring individualized communication preferences is sustained by clinicians after participation in the RIGHTimeCPV intervention6 months after the final DRV during study exit interviews [participant specific

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.

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Sites d'essai

Cette étude compte 1 site d'essai

St. Jude Children's Research Hospital
Memphis, Tennessee, US

Recrutement en cours

Memphis, Tennessee, 38105 US

St. Jude Children's Research Hospital

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