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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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02846038
Study type Observational
Source St. Jude Children's Research Hospital
Contact Erica Kaye, MD
Phone 866-278-5833
Email [email protected]
Status Recruiting
Phase
Start date September 9, 2016
Completion date July 31, 2028

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