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Understanding Communication in Healthcare to Achieve Trust (U-CHAT)

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria

  • - Primary Oncologist: - 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.
Inclusion Criteria
  • - Parents of Children with Cancer: - 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.
Inclusion Criteria
  • - Patients: - 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.
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.

Exclusion Criteria:

  • - Implicitly stated in above inclusion criteria.
  • - Inability or unwillingness of potential research participant or legal guardian/representative to give informed consent.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02846038

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
St. Jude Children's Research Hospital

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Erica Kaye, MD
Principal Investigator Affiliation St. Jude Children's Research Hospital

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Brain Tumors, Solid Tumor
Study Website: View Trial Website
Additional Details

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 patient, if desired) will be asked to complete a survey. Patient-parent dyads will be followed for a total of 24 months from the time of enrollment on study, 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

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

Status

Recruiting

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Site Contact

Erica Kaye, MD

referralinfo@stjude.org

866-278-5833

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