- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498899
Message 2: The Effect of Message Content and Clinical Outcome on Patient's Perception of Physician Compassion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
If you agree to take part in this study, during an already scheduled office visit, you will complete the following:
- Basic information about you will be collected from your medical record (such as your date of birth, date of diagnosis, sex, and religion).
- You will complete 4 questionnaires about any symptoms you may be having, how hopeful you are in general, how you are dealing with the disease, your trust in the medical profession, and your strength of religious faith. It should take about 10 minutes total to complete all questionnaires.
You will then be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Each group will watch a short video that shows actors playing a doctor and patient having a conversation about different cancer treatment options. Each video is about 4 minutes long and will discuss the same material, but the message shown in the videos will be different for each group.
After you watch the video, you will complete 3 questionnaires that will ask about your impression of the doctor in the video, how hopeful you think the doctor was, if you think the doctor was professional, and how you would rate the doctor overall. It should take about 8 minutes total to complete all questionnaires.
You will then read a small story about the patient in the video. Afterwards, you will complete the same 3 questionnaires that you filled out after you watched the video. You will also complete an additional questionnaire about your impression of the doctor's compassion and trustworthiness. This should take less than 10 minutes to complete.
Length of Study:
It should take about 25 minutes total to watch the video and to complete all questionnaires. Your active participation on this study will be over after you have completed the last questionnaire.
Other Information:
You are taking part in this study alone. Your family members will not be in the room with you. If you request, your family may be able remain in the room, but the investigators ask that they remain silent.
This is an investigational study.
Up to 128 participants will be enrolled in this study. All will take part at MD Anderson.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
- Follow up patients seen in the outpatient Supportive Care Center.
- Age >/= 18 years-old
- English speaking
Exclusion Criteria:
- Altered cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video 1 + Questionnaires
Participants complete 4 questionnaires at baseline.
Participants then watch a short video.
At end of video, 3 questionnaires completed.
Participants then read a small story about the patient in the video.
Afterwards, another set of questionnaires completed.
|
Participants complete questionnaires at baseline, after watching a video, and after reading a story about the patient in the video.
Other Names:
Participants watch a video lasting about 4 minutes.
|
|
Experimental: Video 2 + Questionnaires
Participants complete 4 questionnaires at baseline.
Participants then watch a short video.
At end of video, 3 questionnaires completed.
Participants then read a small story about the patient in the video.
Afterwards, another set of questionnaires completed.
|
Participants complete questionnaires at baseline, after watching a video, and after reading a story about the patient in the video.
Other Names:
Participants watch a video lasting about 4 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rating of Physician's Compassion
Time Frame: 1 day
|
Participant's rating of physician's compassion scored 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.
Sum of the five scales gives a final score representing physician's compassion with a 0 to 50 scale.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kimberson C. Tanco, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015-0279
- NCI-2015-01553 (Registry Identifier: NCI CTRP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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