Pediatric CancerNCT05116566
Revealing Information Genuinely & Honestly Across Time: Pediatric Oncology Stakeholder Preferences and Recommendations for Prognostic Communication
An observational study of Pediatric Cancer and Communication, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This study is being conducted to better understand the preferences and recommendations of patients and parents regarding optimal ways to share prognostic communication. Specifically, to learn what stakeholders (i.e., patients, parents, and doctors) believe to be the "right" content, timing, and delivery of this… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer, Communication
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2022to 14 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients, parents and Oncologist meeting the eligibility criteria.
Who may be able to join
- Patients
- Aged 12-25 years
- Recent diagnosis (< 3 months) of a poor prognosis cancer with an estimated survival of 50% or less by the primary oncologist (cohort 1) OR recent history of disease relapse/progression within the past 3 months (cohort 2) OR active enrollment on a phase I/II trial (cohort 3).
- English-speaking
- Parents
- Aged 18 years or older
Show all 10Show fewer
- Parent (or legal caregiver) of a child with cancer of any age who meets the above criteria for cohorts 1-3 OR of a child who died from cancer 6-24 months from enrollment (cohort 4).
- English-speaking
- Oncologists
- Pediatric oncologists who treat patients at SJCRH or who refer patients for treatment to SJCRH
Who cannot join
- Does not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
This study is being conducted to better understand the preferences and recommendations of patients and parents regarding optimal ways to share prognostic communication. Specifically, to learn what stakeholders (i.e., patients, parents, and doctors) believe to be the "right" content, timing, and delivery of this important information.
Specific Aim 1
Read more
- To define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement.
Specific Aim 2
- To engage stakeholders in the design of a patient/parent centered RIGHTime framework and communication intervention to promote individualized, timely prognostic disclosure.
Read the detailed description
This study will have two phases.
Phase 1:
Investigators will define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement. Eligible parents and patients will participate in semi-structured interviews on prognostic communication preferences, stratified by cohort: poor-prognosis diagnosis, advancing disease, phase I/II trial enrollment, and bereavement; eligible oncologists will complete interviews on prognostic disclosure preferences. Participants will participate in a single interview that will last anywhere from 30 to 60 minutes.The interview will be audio-recorded and transcribed. Participant demographic and social determinants of health information will be collected.
Phase 2:
Investigators will partner with a smaller group of stakeholders (parents, patients, and oncologist) from phase 1 to develop a clinical communication guide to help improve communication between patients, families, and cancer doctors. The panel will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.
- Conditions
- Pediatric Cancer, Communication
- Keywords
- Prognostic Communication, Advanced Pediatric Cancer, Bereavement, Caregiver, Children, Oncologist, Parents, Young Adults
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Three distinct sub-cohorts will be targeted for recruitment to represent perspectives across the advancing illness course: patients ≤3 months from a poor- prognosis diagnosis (cohort 1), patients ≤ 3 months from disease relapse or progression (cohort 2), and patients actively enrolled on a phase I/II trials (cohort 3).For cohorts 1-3, patient-parent dyads will be enrolled when eligible; however, an independent patient is eligible for enrollment if the parent consents for the patient's enrollment but declines his/her own enrollment. | |
| Parents | Four distinct sub-cohorts of parents will be targeted for recruitment, including cohorts 1-3 and a fourth bereavement cohort. For cohorts 1-3, patient-parent dyads will be enrolled when eligible; however, an independent parent is eligible for enrollment if the patient declines enrollment, but the parent wishes to participate. | |
| Oncologist | Pediatric oncologists who treat or refer patients for treatment at St. Jude Children's Research Hospital (SJCRH) will be eligible to participate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic Communication Preferences
We will use the rapid analysis (RA) qualitative approach for analysis of interview transcripts methods to define patient, parent, and oncologist preferences and recommendations with respect to timing, content, and delivery of prognostic communication at varying timepoints across the advancing illness course.
Measured: Within 60 days of enrollment
Variables influencing stakeholder preferences
We will use a participatory design approach with user-centered design methods, we will convene a Stakeholder Panel comprising patients, parents, oncologists, and researchers that will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.
Measured: After completion of all interviews; 4 sessions over a period of approximately 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start18 Jun 2022
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica C. Kaye, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116566
- Sponsor's protocol ID
- RIGHTime
- Other IDs
- NCI-2021-12350
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2021
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Christianson C, Farner H, Heidelberg RE, Brandt H, Hinds P, Mack JW, Kaye EC; RIGHTime Communication Collaborative. Codesigning Communication Interventions With Adolescents, Parents, and Clinicians in Pediatric Oncology: A Feasibility Study. Pediatr Blood Cancer. 2026 Jul;73(7):e70382. doi: 10.1002/1545-5017.70382. Epub 2026 May 5.
PubMed 42084190
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealing Information Genuinely & Honestly Across Time: Pediatric Oncology Stakeholder Preferences and Recommendations for Prognostic Communication
- ClinicalTrials.gov ID
- NCT05116566
- Acronym / sponsor ID
- RIGHTime
- Conditions
- Pediatric Cancer, Communication
- Keywords
- Prognostic Communication, Advanced Pediatric Cancer, Bereavement, Caregiver, Children, Oncologist, Parents, Young Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to better understand the preferences and recommendations of patients and parents regarding optimal ways to share prognostic communication. Specifically, to learn what stakeholders (i.e., patients, parents, and doctors) believe to be the "right" content, timing, and delivery of this important information.
Specific Aim 1
- To define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement.
Specific Aim 2
- To engage stakeholders in the design of a patient/parent centered RIGHTime framework and communication intervention to promote individualized, timely prognostic disclosure.
Detailed description
This study will have two phases.
Phase 1:
Investigators will define key stakeholder preferences and recommendations for timing, content, and delivery of prognostic communication across the advancing illness course and bereavement. Eligible parents and patients will participate in semi-structured interviews on prognostic communication preferences, stratified by cohort: poor-prognosis diagnosis, advancing disease, phase I/II trial enrollment, and bereavement; eligible oncologists will complete interviews on prognostic disclosure preferences. Participants will participate in a single interview that will last anywhere from 30 to 60 minutes.The interview will be audio-recorded and transcribed. Participant demographic and social determinants of health information will be collected.
Phase 2:
Investigators will partner with a smaller group of stakeholders (parents, patients, and oncologist) from phase 1 to develop a clinical communication guide to help improve communication between patients, families, and cancer doctors. The panel will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Three distinct sub-cohorts will be targeted for recruitment to represent perspectives across the advancing illness course: patients ≤3 months from a poor- prognosis diagnosis (cohort 1), patients ≤ 3 months from disease relapse or progression (cohort 2), and patients actively enrolled on a phase I/II trials (cohort 3).For cohorts 1-3, patient-parent dyads will be enrolled when eligible; however, an independent patient is eligible for enrollment if the parent consents for the patient's enrollment but declines his/her own enrollment. |
| Parents | – | –Four distinct sub-cohorts of parents will be targeted for recruitment, including cohorts 1-3 and a fourth bereavement cohort. For cohorts 1-3, patient-parent dyads will be enrolled when eligible; however, an independent parent is eligible for enrollment if the patient declines enrollment, but the parent wishes to participate. |
| Oncologist | – | –Pediatric oncologists who treat or refer patients for treatment at St. Jude Children's Research Hospital (SJCRH) will be eligible to participate. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients, parents and Oncologist meeting the eligibility criteria.
Key inclusion criteria (10 listed)
- Patients
- Aged 12-25 years
- Recent diagnosis (< 3 months) of a poor prognosis cancer with an estimated survival of 50% or less by the primary oncologist (cohort 1) OR recent history of disease relapse/progression within the past 3 months (cohort 2) OR active enrollment on a phase I/II trial (cohort 3).
- English-speaking
- Parents
Key exclusion criteria (1 listed)
- Does not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic Communication Preferences
Time frame: Within 60 days of enrollment
We will use the rapid analysis (RA) qualitative approach for analysis of interview transcripts methods to define patient, parent, and oncologist preferences and recommendations with respect to timing, content, and delivery of prognostic communication at varying timepoints across the advancing illness course.
Variables influencing stakeholder preferences
Time frame: After completion of all interviews; 4 sessions over a period of approximately 1-2 years
We will use a participatory design approach with user-centered design methods, we will convene a Stakeholder Panel comprising patients, parents, oncologists, and researchers that will meet across 4 sessions to develop a conceptual framework that explains the interconnecting variables influencing stakeholder preferences and to design a prognostic communication intervention (i.e., a RIGHTime communication guide) that encourages oncologists to provide individualized, timely prognostic disclosure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Derived from this study: PubMed 42084190Christianson C, Farner H, Heidelberg RE, Brandt H, Hinds P, Mack JW, Kaye EC; RIGHTime Communication Collaborative. Codesigning Communication Interventions With Adolescents, Parents, and Clinicians in Pediatric Oncology: A Feasibility Study. Pediatr Blood Cancer. 2026 Jul;73(7):e70382. doi: 10.1002/1545-5017.70382. Epub 2026 May 5.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for Pediatric Cancer
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica C. Kaye, MD, MPH principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Communication, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic Communication Preferences (time frame: Within 60 days of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05116566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.