Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT02846038 |
Other study ID # |
U-CHAT |
Secondary ID |
NCI-2021-10301 |
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 9, 2016 |
Est. completion date |
September 2024 |
Study information
Verified date |
March 2024 |
Source |
St. Jude Children's Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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.