NCT03856060

Brief Summary

This trial assesses patient perception of physician's compassion, communication skills, and professionalism during clinic visits through the use of videos and questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

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

February 21, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 30, 2019

Completed
5.4 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

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5.4 years

First QC Date

February 21, 2019

Last Update Submit

September 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients' perception of physicians' compassion after they watch the first video

    Quantified by the total score of ratings from a comprehensive 5-item tool which assesses dimensions such as warm/cold, pleasant/unpleasant, compassionate/distant, sensitive/insensitive, and caring/uncaring (ranging from 0 to 10 for each item, and from 0 to 50 for the total score). Physicians' compassion, communication skills and professionalism will be compared between standard electronic health record (EHR) and integrated EHR groups at the end of each video using a two-sample t-test or Wilcoxon rank-sum test when appropriate. The mixed model will be applied to further explore the patterns of physicians' compassion, communication skills and professionalism from both videos. Patients' preference of physician and perception of EHR will be compared between standard EHR and integrated EHR groups using Chi-squared test or Fisher's exact test when appropriate. Logistic regression model will also be employed.

    1 year" or "up to 24 weeks", "through study completion

Study Arms (2)

Group I (questionnaires, videos)

EXPERIMENTAL

Patients complete questionnaires and watch a video portraying a physician using a standard EHR and then another portraying a physician using an integrated model of EHR during communication over 35 minutes.

Other: Questionnaire AdministrationOther: Video

Group II (video, questionnaire)

EXPERIMENTAL

Patients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes.

Other: Questionnaire AdministrationOther: Video

Interventions

Complete questionnaires

Group I (questionnaires, videos)Group II (video, questionnaire)
VideoOTHER

Watch videos of doctor and patient interaction in different settings

Group I (questionnaires, videos)Group II (video, questionnaire)

Eligibility Criteria

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

You may qualify if:

  • Patients with a diagnosis of cancer either early disease or advanced cancer defined as locally advanced, recurrent or metastatic disease.
  • Outpatients (either new referrals or follow-ups) seen in the Supportive Care Clinic.
  • English speaking.
  • Patients with normal cognitive status (Memorial Delirium Assessment Scale \[MDAS\] =\< 6/30) who can understand the nature and purpose of the study and have the ability to complete the consent process.

You may not qualify if:

  • Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be measured by the Edmonton Symptom Assessment Scale (ESAS) and Memorial Delirium Assessment Scale (MDAS), and will be determined by the principal investigator and/or attending physician who is caring for the patient during that visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisRecurrence

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Ali Haider, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 27, 2019

Study Start

March 30, 2019

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations