NCT02846038Completed
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
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
Source: ClinicalTrials.gov · Last updated 25 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 138 (actual)
- First submitted
- 20 Jul 2016
- Start date
- 9 Sept 2016
- Primary completion date
- 10 Apr 2024
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT02846038
What you commit to
- Study type: Observational
- Participants enrolled: 138
- From 9 Sept 2016 to the primary completion date, 10 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Implicitly stated in above inclusion criteria.
- Inability or unwillingness of potential research participant or legal guardian/representative to give informed consent.
Who the study is looking for
- 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.
- 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.
- 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.
Sex: All
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.