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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02357108
Other study ID # 2012-0113
Secondary ID NCI-2015-01419
Status Completed
Phase N/A
First received January 29, 2015
Last updated July 14, 2016
Start date May 2013
Est. completion date August 2015

Study information

Verified date July 2016
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

If participant agree to take part in the study, basic information will be collected (such as date of birth, date of diagnosis, sex, and religion). Participant will also complete questionnaires about any symptoms they may be having, how hopeful they are, how they are accepting the disease, their trust in the medical profession, and how they like information to be delivered to them.

After completing the questionnaires, they will be randomly assigned (as the roll of dice) to one of 4 groups.

Regardless of which group they are in, they will watch 2 short videos that show actors portraying a doctor and patient having a conversation about treatment options in a clinical setting. Both videos will discuss the same material, but the order of the videos and the actors in the videos will be different for each group. Both videos are about 4 minutes long.

After watching each video, the participant will complete 3 questionnaires about the doctor in the video. It should take about 38 minutes to watch both videos and to complete all of the questionnaires.

After they have watched both videos, they will be asked to choose which doctor they preferred and to briefly explain the reasons why they chose that doctor.

Length of Study:

Participant will be off study after they have completed the last questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease

2. Patients treated as outpatients by the Supportive and Palliative Care team.

3. Age >/= 18 years-old

4. English speaking

5. Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.

Exclusion Criteria:

1) 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

Other:
Video
Watch two short videos with a 4-minute interval between the two of them, estimate 8 minutes to watch both the videos.
Behavioral:
Survey
One set of surveys before first video and one set after each video played, estimate total of 30 minutes for all surveys.

Locations

Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
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