NCT02969031

Brief Summary

The overarching goal of this project is to improve communication between oncologists and their patients by ensuring that the patient's voice is heard in the medical encounter. Thus, the hope is to improve the experience for patients living with cancer. The investigators seek to accomplish this goal by providing oncologists communication skills training that includes feedback on their own audio-recorded conversations. The feedback will come from two sources: 1) Professional research assistant coders who will identify objective learning opportunities based on specific coding criteria and 2) Trained patient reviewers who will listen to the recordings and offer their own, subjective feedback at key moments in the encounters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Feb 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 14, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 3, 2020

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

November 16, 2016

Results QC Date

October 30, 2019

Last Update Submit

December 16, 2019

Conditions

Keywords

communication

Outcome Measures

Primary Outcomes (1)

  • Provider to Patient Communication Score

    The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.

    6 months

Secondary Outcomes (1)

  • Empathic Response to Patient Expressions of Negative Emotions

    6 months

Study Arms (2)

Enhanced SCOPE training

EXPERIMENTAL

Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.

Behavioral: Enhanced SCOPE training

Standard Communication training

ACTIVE COMPARATOR

Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current "standard" communication PIM).

Behavioral: Standard Communication training

Interventions

Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.

Enhanced SCOPE training

Standard Communication training

Standard Communication training

Eligibility Criteria

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

You may qualify if:

  • All American Board of Internal Medicine (ABIM) Board certified oncologists practicing in the U. S. and enrolled in Maintenance of Certification.
  • Have a study-compatible smart phone.
  • Eligible patients will have metastatic cancer.
  • At least 18 years of age.
  • Speak and read English.
  • Receive oncology care from an enrolled oncologist.

You may not qualify if:

  • Dana Farber Cancer Institute oncologists and oncologists who do not speak English to their patients.
  • Patients who do not speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsCommunication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Julie Goldman
Organization
Dana-Farber Cancer Institute

Study Officials

  • James A. Tulsky, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Psychosocial Oncology and Palliative Care

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 21, 2016

Study Start

February 14, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

January 3, 2020

Results First Posted

January 3, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations