NCT05810987

Brief Summary

Difficult conversations are common in oncology practice and patient-centered communication is essential to care for individuals with cancer. Within oncology training programs, communication training is mostly unstructured observation and feedback in the clinic and many learners receive inadequate training. Currently, educational resources are limited, and residents have indicated a desire for more education on end-of-life communication skills. A formal communication curriculum could fill a gap and help to standardize teaching and evaluation. The overall goal of this study is to establish an effective communication skills curriculum for oncology residents that can be delivered remotely and that addresses difficult conversations with cancer patients. Through this preliminary study, we will explore the feasibility of a randomized controlled trial comparing different training experiences to understand how best to help oncology residents develop strong end-of-life communication skills.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

February 28, 2023

Last Update Submit

January 13, 2025

Conditions

Keywords

Communication, Serious Illness, Education, Palliative Care

Outcome Measures

Primary Outcomes (4)

  • COM-ON (Communication in Oncology) Checklist

    Validated rating scale assessing general and specific communication skills in oncology. Items are rated on a five-point Likert scale ranging from 0 = ''Skill not demonstrated at all'' to 5 = ''Skill fully demonstrated'', with higher scores denoting higher quality communication.

    3 months

  • QQPPI (Questionnaire on the Quality of Physician-Patient Interaction)

    Validated patient-facing rating scale of for quality of physician communication. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.

    3 months

  • Assessment rubric for 'entrustable professional activities' (EPAs)

    Medical interaction analysis rating scale as defined by the Royal College of Physicians and Surgeons of Canada. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.

    3 months

  • Global rating scale

    Overall rating scale of quality of physician communication. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.

    3 months

Secondary Outcomes (2)

  • End-of-Life Professional Caregiver Survey (EPCS)

    3 months

  • RESTORED Questionnaire

    Immediately after the intervention

Study Arms (2)

ELMs and virtual SP encounters

EXPERIMENTAL

A virtual communication curriculum featuring electronic learning modules (ELMs) and skills sessions with standardized patients (SPs) along with coaching feedback.

Other: RESTOREBehavioral: Medical Interaction and Coaching

ELMs alone

ACTIVE COMPARATOR

A virtual communication curriculum featuring electronic learning modules (ELMs) only.

Other: RESTORE

Interventions

RESTOREOTHER

Virtual educational curriculum organized into the following modules: Module Specific Communication Strategies 1. Introduction 2. Preparing for and introducing a conversation \[Consider personal bias /Building rapport /Ask permission\] 3. Assessing understanding \[Avoid correcting /Open ended questions\] 4. Giving information \[Give a warning shot /Using silence /Wish/worry/wonder\] 5. Explore goals \[Reflective listening /Naming, validating emotion 6. Summarizing and recommending a plan \[Values-based recommendation /Aligning with goals /REMAP (Reframe, Expect emotion, Map goals, Align, Propose plan)\]

ELMs aloneELMs and virtual SP encounters

Skills sessions with standardized patients (SPs) along with coaching feedback.

ELMs and virtual SP encounters

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical and radiation oncology residents and fellows at McMaster University, and medical oncology residents at the Universities of Ottawa and Toronto.
  • Enrollment in a participating training program, ability to participate in study-related activities in English, access to internet and a video-enabled computer (either personal or institutional) to support study-related activities

You may not qualify if:

  • Not enrolled in a participating training program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juravinski Cancer Centre - Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

MeSH Terms

Conditions

NeoplasmsCommunication

Interventions

Restore polishing paste

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Oren Levine, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

April 13, 2023

Study Start

March 1, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations