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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02957565
Other study ID # 2016-0494
Secondary ID NCI-2017-00621
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2016
Est. completion date January 2, 2020

Study information

Verified date November 2020
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this research study is to learn how patients feel about their doctors' attitudes toward supportive care and treatment options for advanced cancer patients.


Description:

If you agree to take part in this study, during an already-scheduled office visit, you will complete 5 questionnaires about your symptoms, your physical and emotional health, and your trust in the medical profession. These questionnaires should take about 17 minutes to complete. Study Groups: After you have completed the first 5 questionnaires, you will be randomly assigned (as in the roll of the dice) to 1 of 4 groups. Each group will watch 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options. Each video is about 4 minutes long and will discuss the same content, but setting of each video will be different. After watching the first video, you will complete 3 questionnaires about your opinions of the doctor's behavior. These questionnaires should take about 5 minutes to complete. After you watch the second video, you will complete the same 3 questionnaires. You will also complete 2 additional questionnaires about which doctor you would rather have as your doctor and why, and your opinion about the setting of the examination room in the video. It should take about 8 minutes to complete these questionnaires. Length of Study: It should take about 38 minutes to watch both videos and to complete all questionnaires. Your participation on this study will be over after you have completed the last questionnaire. Other Information: You must attend the study visit alone. Your family members should not be in the room with you while you are participating in the study. You may request to have family members remain in the room, but they must remain silent so that they do not influence your opinions. This is an investigational study. Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date January 2, 2020
Est. primary completion date January 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with the diagnosis of advanced cancer defined as locally advanced, recurrent or metastatic disease. 2. Outpatients (either new referrals or follow ups) seen in the Supportive Care Clinic. 3. Age >/= 18 years old 4. English speaking 5. Patients with normal cognitive status (Memorial Delirium Assessment Scale (MDAS) </=6/30) who are able to understand the nature and purpose of the study and have the ability to complete the consent process. Exclusion Criteria: 1) Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be determined by the principle investigator and/or attending physician who is caring for the patient during that visit.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Baseline Questionnaires
Participant completes 5 questionnaires during an already-scheduled office visit. Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession. These questionnaires should take about 17 minutes to complete.
Other:
Videos
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options. Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
Behavioral:
Assessment Questionnaires
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.

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 Participant's rating of physician's compassion assessed 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 gives a final score representing physician's compassion with a 0 to 50 scale. 1 day
Secondary Participant's Rating of Physician Communication Skills Participant's rating of physician communication skills assessed by using a 14-item tool consisting of 1 to 4 numerical rating scales assessing communication skills. The sum of these 14 scales gives a final score representing physician's communication skills with a 14 to 70 scale. 1 day
Secondary Participant's Rating of Physician's Professionalism Participant's rating of physician's professionalism assessed by using a 4-item tool assessing politeness, listening, explaining the condition and treatment to the participant and participant's involvement in treatment decisions. Participant rates from poor to very good. 1 day
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