Developing an Experimental Framework to Evaluate Oncologist Emotion Regulation

NCT05365763 | Completed

• 1 other identifier: STUDY02000696
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The research team recruited physicians (medical oncologists and specialty palliative care providers) trained in a communication tool called the serious illness conversation guide. Physicians conducted a simulated, telehealth serious illness conversation with an actor playing the role of a patient with advanced cancer. Physicians completed psychologic inventories before and after the encounter, documented the encounter using a template in the electronic medical record, and then participated in a structured interview afterwards discussing what they were feeling during the encounter and how it impacted the encounter. Physicians also wore three heart rate variability sensors during the simulated encounter.

Conditions

Communication

Keywords

serious illness conversation; serious illness communication

Outcome Measures

Primary Outcomes (1)

• Investigator Assessed Feasibility of collecting clinician derived data on emotion regulation

  This is a composite measure with four criteria: 1) \>60% approached clinicians enroll on study; 2) \<5% of missing time from encounter audio file; 3) \<20% of missing time from heart rate variability collection; and 4) survey completion rates \>90% of all items. All four criteria must be met for investigators to assess as feasible.

  Day 1

Secondary Outcomes (2)

• The number of participants with heart rate variability data collected for more than 90% of the conversation task

  Day 1

• Completeness of Documentation

  Day 1

Study Arms (2)

Medical oncologists

5 medical oncologists; trained in the serious illness conversation guide

Behavioral: Simulated telehealth serious illness conversation visit

specialty palliative care

6 specialty palliative care physicians; trained in serious illness conversation guide

Behavioral: Simulated telehealth serious illness conversation visit

Interventions

Simulated telehealth serious illness conversation visit BEHAVIORAL

The study team will instruct the participant to relax, and record biometric data for a total 7 minutes (the beginning two minutes is to allow for physiologic adaptation). Simulated Encounter The study team will train experienced actors in the same case, a patient with a metastatic soft tissue sarcoma already on second-line chemotherapy. The physicians will receive a simulated medical file that contains a prognosis in a single format: a range-based, time prognosis (e.g. months to a year). The actor script and medical file will be developed by a multidisciplinary team (e.g. oncologist, palliative care, emotion scientist). The encounter will occur via tele-video platform (ZOOM®) and will be video-recorded. During the encounter participant physicians will wear three biometric sensors.

Medical oncologists; specialty palliative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Attending physicians in medical oncology or palliative care

You may qualify if:

• Clinicians who have been previously trained in the serious illness conversation guide. Two groups of participants will be recruited.
• hematology/oncology faculty
• specialty-trained palliative care clinicians

You may not qualify if:

• individuals who have a diagnosis of cardiovascular dysfunction

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Garrett T Wasp, MD, MPH

  Dartmouth Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: May 9, 2022
• Study Start: May 1, 2020
• Primary Completion: August 28, 2021
• Study Completion: September 30, 2021
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (1)