Brain TumorsNCT02846038
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
An observational study of Brain Tumors and Solid Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Honest, clear, and empathetic communication between pediatric oncologists (POs) and parents of children with cancer (POCCs) is imperative to facilitating therapeutic alliance and ensuring that medical management aligns with the families' goals of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Tumors, Solid Tumor
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2016to 10 Apr 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Participants will be selected from patients receiving care in the Solid Tumor or Neuro-Oncology clinics at St. Jude Children's Research Hospital.
Who may be able to join
- Primary oncologist is an attending physician (age 18+) who provides medical care to patients in the outpatient Solid Tumor or Neuro-Oncology clinics at St. Jude Children's Research Hospital.
- Primary hematology-oncology fellows (age 18+) who follow patients along with the primary oncologist will be eligible to participate in audio-recorded disease reevaluation conversations (and fellow contributions will be distinguished from primary oncologist contributions); however, they will not be eligible to complete post-conversation surveys nor semi-structured interviews.
- Caregiver is 18 years of age or older.
- Caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian.
- If more than 1 set of parents are involved, the caregiver with legal decision-making responsibilities will be eligible for participation.
- Caregiver is comfortable speaking and reading English.
Show all 18Show fewer
- Patient's primary oncologist is enrolled in this study.
- Patient (age ≤30 years) has been diagnosed with either a solid tumor and/or a brain tumor.
- Patient's primary pediatric oncologist documents or reports his/her impression that patient's likelihood of cure is 50% or less.
- Patient is projected to have ≥ 2 future time points of disease reevaluations, as documented in the electronic medical record (EMR) and/or confirmed by the patient's primary oncologist.
- Patient is being treated for one of the above high-risk diseases with <3 months until end-of-therapy disease evaluation, OR
- Patient's disease has relapsed, progressed, or not responded to therapy, as documented in the EMR and/or confirmed by the child's pediatric oncologist OR
- Patient is being treated for a uniformly fatal disease, such as diffuse intrinsic pontine glioma, or a disease in which the primary oncologist believes that the patient will almost certainly die, such as glioblastoma multiforme.
- Inclusion Criteria - Non-Primary Oncologist Care Team Members, Patient's Extended Family Member, or Friend of the Family:
- Patient's primary oncologist is enrolled on the study.
- Patient's caregiver is enrolled on the study.
- Patient's caregiver has given verbal permission for non-primary oncologist clinical members of the patient's care team, the extended family member, or friend of the family to be present during the conversation between the patient's primary oncologist and the patient's caregiver.
- any non-primary oncologist members of the patient's clinical care team, the extended family members, or friends of the family (all age 18+ years) have all given verbal consent to be audio-recorded prior to the beginning of the conversation, in case they speak during the conversation between patient's primary oncologist and the patient's caregiver.
Who cannot join
- Implicitly stated in above inclusion criteria.
- Inability or unwillingness of potential research participant or legal guardian/representative to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Understanding Communication in Healthcare to Achieve Trust (U-CHAT): A Prospective Longitudinal Investigation of Communication Between Pediatric Oncologists, Children/Adolescents With High-Risk Cancer, and Their Families at the Stressful Time-Points of Disease
Honest, clear, and empathetic communication between pediatric oncologists (POs) and parents of children with cancer (POCCs) is imperative to facilitating therapeutic alliance and ensuring that medical management aligns with the families' goals of care. Communication is particularly important during conversations about disease reevaluation, which often necessitate parental decision-making in the context of emotional distress. POs employ a spectrum of communication styles and strategies during challenging conversations, and there is no consensus regarding linguistic or thematic metrics for high quality communication of upsetting information. In order to better understand how POs communicate difficult information to POCCs, the investigators propose a pilot study designed to accomplish the following primary aim:
Primary Objective:
Read more
- To identify recurrent verbal and nonverbal (e.g. the use of pauses/silence) communication techniques employed by POs in the delivery of difficult prognostic information to POCCs through content analysis of audio-recorded conversations between POs and parents of children with high risk cancer at the time of disease reevaluation.
The study expects to enroll up to: 80 patient participants, 80 parents, and 15 primary pediatric oncologists (total = 175).
Non-primary oncologist members of the clinical care team, extended family members, or friends of the family may also participate, if they choose to do so.
Read the detailed description
Data collection will occur at each disease reevaluation, during which time the conversation will be audio-recorded and data will be abstracted from the medical record. Additionally, 2 surveys will be completed at specific time points by both the oncologist and the parent. Lastly, interviews will be offered to both the oncologist and the parent/patient following any audio-recorded conversation in which difficult news was discussed.
Disease reevaluation will be defined as any of the following interventions performed for the purposes of assessing disease status:
- Diagnostic imaging
- Lumbar puncture with cerebrospinal fluid analysis
- Bone marrow aspiration and/or biopsy
- Surgical biopsy or resection
The first time point for data collection with be at the time of the patient's first meeting with their oncologist to discuss the results of disease reevaluation. This discussion will be audio-recorded. The parent will be asked to complete a survey within 7 days. Those receiving difficult news will have the opportunity to participate in a brief interview with a study team member regarding their experience. Patients who are at least 12 years old will also have this opportunity, separate from their parents, if desired by the patient and approved by the parent. Interviews may be in person or by phone and have no set length.
The next time point for data collection will coincide with any time the patient/parents meet with their oncologist to discuss results of a disease reevaluation. Each conversation will be audio-recorded. If difficult news is delivered during the discussion, the parent and oncologist will be asked to complete a second survey for first bad news conversation, following the baseline recording. Parent, patient, and oncologist will be asked to participate in an interview for all bad news conversation.
Patient-parent dyads will be followed for a total of 24 months from the time of enrollment on study (defined as the date of first audio recording rather than date of actual consent), in the context of patients who do not experience disease relapse, progression, or refractory disease. Dyads in which patients experience disease relapse, progression, or refractory disease will be followed for a total of 24 months from the time of first disease relapse or progression while on study.
All data analyzed from audio-recordings will be permanently erased from recorders following completion of data analysis. Participants may request to discontinue to the study at any time.
For previously enrolled patients, (enrolled prior to revision 3.1), a retrospective chart review will be done to collect additional clinical data.
- Conditions
- Brain Tumors, Solid Tumor
- Keywords
- Pediatric cancer, Childhood cancer, High-risk disease, Prognosis, Communication, Bad news, Pediatric oncologist, Parent, Relapse, Progression
- Medical subject headings
- Brain Neoplasms, Neoplasms, Communication, Recurrence, Disease Progression
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 |
|---|---|---|
| Patient | Patients at St. Jude Children's Research Hospital who meet the eligibility criteria and consent to participate. | |
| Primary oncologist | Primary pediatric oncologists who meet the eligibility criteria and consent to participate. | |
| Parents of patient | Parents of the enrolled patient who meet eligibility criteria and consent to participate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of communication styles employed
Measured: From first patient visit for disease reevaluation through up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start9 Sep 2016
- Primary completion10 Apr 2024
- Study completion10 Apr 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 Brain TumorsStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Erica Kaye, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846038
- Sponsor's protocol ID
- U-CHAT
- Other IDs
- NCI-2021-10301
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2016
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Superdock AK, Porter AS, Spears W, Baker JN, Mack JW, Kaye EC. Spiritual Communication Between Pediatric Oncologists, Caregivers, and Patients With Brain Tumors. Pediatr Blood Cancer. 2025 Jul;72(7):e31721. doi: 10.1002/pbc.31721. Epub 2025 Apr 21.
PubMed 40259532
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Communication in Healthcare to Achieve Trust (U-CHAT): A Prospective Longitudinal Investigation of Communication Between Pediatric Oncologists, Children/Adolescents With High-Risk Cancer, and Their Families at the Stressful Time-Points of Disease
- ClinicalTrials.gov ID
- NCT02846038
- Acronym / sponsor ID
- U-CHAT
- Conditions
- Brain Tumors, Solid Tumor
- Keywords
- Pediatric cancer, Childhood cancer, High-risk disease, Prognosis, Communication, Bad news, Pediatric oncologist, Parent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
Honest, clear, and empathetic communication between pediatric oncologists (POs) and parents of children with cancer (POCCs) is imperative to facilitating therapeutic alliance and ensuring that medical management aligns with the families' goals of care. Communication is particularly important during conversations about disease reevaluation, which often necessitate parental decision-making in the context of emotional distress. POs employ a spectrum of communication styles and strategies during challenging conversations, and there is no consensus regarding linguistic or thematic metrics for high quality communication of upsetting information. In order to better understand how POs communicate difficult information to POCCs, the investigators propose a pilot study designed to accomplish the following primary aim:
Primary Objective:
- To identify recurrent verbal and nonverbal (e.g. the use of pauses/silence) communication techniques employed by POs in the delivery of difficult prognostic information to POCCs through content analysis of audio-recorded conversations between POs and parents of children with high risk cancer at the time of disease reevaluation.
The study expects to enroll up to: 80 patient participants, 80 parents, and 15 primary pediatric oncologists (total = 175).
Non-primary oncologist members of the clinical care team, extended family members, or friends of the family may also participate, if they choose to do so.
Detailed description
Data collection will occur at each disease reevaluation, during which time the conversation will be audio-recorded and data will be abstracted from the medical record. Additionally, 2 surveys will be completed at specific time points by both the oncologist and the parent. Lastly, interviews will be offered to both the oncologist and the parent/patient following any audio-recorded conversation in which difficult news was discussed.
Disease reevaluation will be defined as any of the following interventions performed for the purposes of assessing disease status:
- Diagnostic imaging
- Lumbar puncture with cerebrospinal fluid analysis
- Bone marrow aspiration and/or biopsy
- Surgical biopsy or resection
The first time point for data collection with be at the time of the patient's first meeting with their oncologist to discuss the results of disease reevaluation. This discussion will be audio-recorded. The parent will be asked to complete a survey within 7 days. Those receiving difficult news will have the opportunity to participate in a brief interview with a study team member regarding their experience. Patients who are at least 12 years old will also have this opportunity, separate from their parents, if desired by the patient and approved by the parent. Interviews may be in person or by phone and have no set length.
The next time point for data collection will coincide with any time the patient/parents meet with their oncologist to discuss results of a disease reevaluation. Each conversation will be audio-recorded. If difficult news is delivered during the discussion, the parent and oncologist will be asked to complete a second survey for first bad news conversation, following the baseline recording. Parent, patient, and oncologist will be asked to participate in an interview for all bad news conversation.
Patient-parent dyads will be followed for a total of 24 months from the time of enrollment on study (defined as the date of first audio recording rather than date of actual consent), in the context of patients who do not experience disease relapse, progression, or refractory disease. Dyads in which patients experience disease relapse, progression, or refractory disease will be followed for a total of 24 months from the time of first disease relapse or progression while on study.
All data analyzed from audio-recordings will be permanently erased from recorders following completion of data analysis. Participants may request to discontinue to the study at any time.
For previously enrolled patients, (enrolled prior to revision 3.1), a retrospective chart review will be done to collect additional clinical data.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Patients at St. Jude Children's Research Hospital who meet the eligibility criteria and consent to participate. |
| Primary oncologist | – | –Primary pediatric oncologists who meet the eligibility criteria and consent to participate. |
| Parents of patient | – | –Parents of the enrolled patient who meet eligibility criteria and consent to participate. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be selected from patients receiving care in the Solid Tumor or Neuro-Oncology clinics at St. Jude Children's Research Hospital.
Key inclusion criteria (18 listed)
- Primary oncologist is an attending physician (age 18+) who provides medical care to patients in the outpatient Solid Tumor or Neuro-Oncology clinics at St. Jude Children's Research Hospital.
- Primary hematology-oncology fellows (age 18+) who follow patients along with the primary oncologist will be eligible to participate in audio-recorded disease reevaluation conversations (and fellow contributions will be distinguished from primary oncologist contributions); however, they will not be eligible to complete post-conversation surveys nor semi-structured interviews.
- Caregiver is 18 years of age or older.
- Caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian.
- If more than 1 set of parents are involved, the caregiver with legal decision-making responsibilities will be eligible for participation.
Key exclusion criteria (2 listed)
- Implicitly stated in above inclusion criteria.
- Inability or unwillingness of potential research participant or legal guardian/representative to give informed consent.
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
Number of communication styles employed
Time frame: From first patient visit for disease reevaluation through up to 24 months
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 25 Jul 2024.
- Derived from this study: PubMed 40259532Superdock AK, Porter AS, Spears W, Baker JN, Mack JW, Kaye EC. Spiritual Communication Between Pediatric Oncologists, Caregivers, and Patients With Brain Tumors. Pediatr Blood Cancer. 2025 Jul;72(7):e31721. doi: 10.1002/pbc.31721. Epub 2025 Apr 21.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Erica Kaye, MD 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 Brain Tumors and Solid Tumor, 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 18 inclusion and 2 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 25 Jul 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?
Number of communication styles employed (time frame: From first patient visit for disease reevaluation through up to 24 months). 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 NCT02846038, 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 25 Jul 2024.