NCT02357108

Brief Summary

The goal of this study is to learn what types of conversations patients prefer to have with their doctor about treatment options and how patients view their doctor's compassion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration 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

Study Start

First participant enrolled

May 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

January 29, 2015

Last Update Submit

July 14, 2016

Conditions

Keywords

Supportive Caretreatment optionsdoctor's compassion

Outcome Measures

Primary Outcomes (1)

  • Participant's Rating of Physician's Compassion

    Physician compassion tested using compassion data from the first video viewed by each patient as assessed by a Physician Compassion Assessment survey. Patient's rating of physician's compassion by using a 5-item tool consisting of five 0-10 numerical rating scales assessing five dimensions: warm-cold, pleasant-unpleasant, compassionate-distant, sensitive insensitive, caring-uncaring. The sum of the five scales will give a final score representing physician's compassion with a 0 to 50 scale.

    Approximately 38 minutes for video viewing and surveys.

Study Arms (4)

Group 1: Video/Doctor Sequence 1

ACTIVE COMPARATOR

Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video)

Other: VideoBehavioral: Survey

Group 2: Video/Doctor Sequence 2

ACTIVE COMPARATOR

Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video)

Other: VideoBehavioral: Survey

Group 3: Video/Doctor Sequence 3

ACTIVE COMPARATOR

Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video)

Other: VideoBehavioral: Survey

Group 4: Video/Doctor Sequence 4

ACTIVE COMPARATOR

Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video)

Other: VideoBehavioral: Survey

Interventions

VideoOTHER

Watch two short videos with a 4-minute interval between the two of them, estimate 8 minutes to watch both the videos.

Group 1: Video/Doctor Sequence 1Group 2: Video/Doctor Sequence 2Group 3: Video/Doctor Sequence 3Group 4: Video/Doctor Sequence 4
SurveyBEHAVIORAL

One set of surveys before first video and one set after each video played, estimate total of 30 minutes for all surveys.

Also known as: Survey Questionnaires, questionnaire
Group 1: Video/Doctor Sequence 1Group 2: Video/Doctor Sequence 2Group 3: Video/Doctor Sequence 3Group 4: Video/Doctor Sequence 4

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
  • Patients treated as outpatients by the Supportive and Palliative Care team.
  • Age \>/= 18 years-old
  • English speaking
  • Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.

You may not qualify if:

  • \) Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation, as determined by the Principal Investigator or by the attending palliative care physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Tanco K, Rhondali W, Perez-Cruz P, Tanzi S, Chisholm GB, Baile W, Frisbee-Hume S, Williams J, Masino C, Cantu H, Sisson A, Arthur J, Bruera E. Patient Perception of Physician Compassion After a More Optimistic vs a Less Optimistic Message: A Randomized Clinical Trial. JAMA Oncol. 2015 May;1(2):176-83. doi: 10.1001/jamaoncol.2014.297.

Related Links

MeSH Terms

Interventions

Videotape RecordingSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kimberson C. Tanco, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 6, 2015

Study Start

May 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations