CancerNCT06993688
Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit
A study testing Prognostic Communication-Patient/parent, Prognostic Communication-CPC and Prognostic Communication-Oncologist in people with Cancer and Communication, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Communication
- What is being tested?
- Prognostic Communication-Patient/parent, Prognostic Communication-CPC and Prognostic Communication-Oncologist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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:
Show all 12Show fewer
- 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
- Inclusion Criteria: Communication Preferences Companions (CPCs)
- 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
Who cannot join
- Does not meet the stated inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Erica C. Kaye, 866-278-5833, referralinfo@stjude.org
Erica C. Kaye, MD,MPH
About this study
Official title: Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit (RIGHTimeCPV) Pilot
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
Read more
- 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.
Read the detailed description
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).
- Conditions
- Cancer, Communication
- Being tested
- Prognostic Communication-Patient/parent, Prognostic Communication-CPC, Prognostic Communication-Oncologist
- Keywords
- Prognostic Communication, Cancer, Poor Prognosis, Participants 12-25 years of age, Caregivers, Pediatric oncologists, Communication Preferences Companions
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic Communication-Patient/parentBehavioural
- 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-CPCBehavioural
- 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-OncologistBehavioural
- CPC and oncologist discuss the CPV form
- Oncologist, patient/parent, and CPC attend next disease re-evaluation visit together
| Study group | Role | What they receive |
|---|---|---|
| RIGHTimeCPV intervention: Patients and Caregivers (parents) | Other | 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') Receives: Behavioral: Prognostic Communication-Patient/parent |
| RIGHTimeCPV intervention: Psychosocial/nursing clinicians | Other | 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 Receives: Behavioral: Prognostic Communication-CPC |
| RIGHTimeCPV intervention: Pediatric oncologists | Other | Pediatric oncologists who treat participating patients/parents Receives: Behavioral: Prognostic Communication-Oncologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 6 months after the final DRV during study exit interviews [participant specific
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start16 Jun 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erica C. Kaye, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993688
- Sponsor's protocol ID
- RIGHTimeCPV
- Other IDs
- K08CA266935, NCI-2025-03410
- Status last verified
- Aug 2026
- First submitted
- 6 May 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revealing Information Genuinely & Honestly Across Time - Communication Preferences Visit (RIGHTimeCPV) Pilot
- ClinicalTrials.gov ID
- NCT06993688
- Acronym / sponsor ID
- RIGHTimeCPV
- Conditions
- Cancer, Communication
- Keywords
- Prognostic Communication, Cancer, Poor Prognosis, Participants 12-25 years of age, Caregivers, Pediatric oncologists, Communication Preferences Companions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 29 May 2025 (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.
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.
Detailed description
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RIGHTimeCPV intervention: Patients and Caregivers (parents) | Other | Behavioral: Prognostic Communication-Patient/parentPediatric 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 | Other | Behavioral: Prognostic Communication-CPCPsychosocial/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 | Other | Behavioral: Prognostic Communication-OncologistPediatric oncologists who treat participating patients/parents |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (1 listed)
- Does not meet the stated 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prognostic Communication-Patient/parent* 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. | Behavioural | RIGHTimeCPV intervention: Patients and Caregivers (parents) |
| Prognostic Communication-CPC* 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. | Behavioural | RIGHTimeCPV intervention: Psychosocial/nursing clinicians |
| Prognostic Communication-Oncologist* CPC and oncologist discuss the CPV form * Oncologist, patient/parent, and CPC attend next disease re-evaluation visit together | Behavioural | RIGHTimeCPV intervention: Pediatric oncologists |
Primary outcome
Feasibility of implementing the RIGHTimeCPV 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
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 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
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 intervention
Time frame: 6 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.
2 secondary outcomes
Potential impact of the RIGHTimeCPV intervention on communication quality, concordance in prognostic understanding, and therapeutic alliance between patients/families 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
Time frame: 6 months after the final DRV during study exit interviews [participant specific
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
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?
A study testing Prognostic Communication-Patient/parent, Prognostic Communication-CPC and Prognostic Communication-Oncologist in people with 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 12 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica C. Kaye, MD, MPH (866-278-5833, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing the RIGHTimeCPV 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.