- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035448
Communication Strategies to Introduce Psychology Services
A Randomized Controlled Trial of Communication Strategies to Introduce Psychology Services in the Palliative Care Setting
The goal of this research study is to learn about advanced cancer patients' preferences about how psychology services are introduced.
This is an investigational study.
Up to 110 participants will be enrolled in this study. All will take part at MD Anderson.
Study Overview
Status
Intervention / Treatment
Detailed Description
If you agree to take part in this study, during an already-scheduled office visit, you will complete 3 questionnaires about your symptoms, your emotional health, and if you have ever participated in psychiatric or psychology services. These questionnaires should take about 9 minutes to complete.
All participants will watch 2 short videos. The videos show actors playing a doctor, counselor, and patient, discussing psychology service options. Each video is about 1 minute and 30 seconds long and will discuss the same material, but the content of each video will be different. The order in which they are presented will be randomly assigned (as in the flip of a coin). You will have an equal chance of seeing either video first.
After you watch the second video, you will complete 3 questionnaires about whether you think 1 of the videos was better than the other, and about your attitude toward psychology services. These questionnaires should take about 4 minutes to complete.
Length of Study:
It should take about 16 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:
We will ask your caregiver(s) to leave the room while the videos are played. In case they decide to stay, we will ask them to keep silent.
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
Description
Inclusion Criteria:
- Age >/= 18 years-old
- Can speak, read, and understand English
- Diagnosis of locally advanced, recurrent, or metastatic disease
- Patients treated as outpatients by the supportive and palliative care team
- Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process
Exclusion Criteria:
- Previous psychological counseling received in supportive care department
- Patients with severe symptom distress as assessed by nursing staff
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video 1: Counselor Alone
Participants complete 3 assessment questionnaires during an already-scheduled office visit. Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options. Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. |
Participants complete 3 assessment questionnaires during an already-scheduled office visit. These questionnaires should take about 9 minutes to complete. Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. These questionnaires should take about 4 minutes to complete.
Other Names:
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
|
Experimental: Video 2: Doctor + Counselor
Participants complete 3 assessment questionnaires during an already-scheduled office visit. Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options. Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. |
Participants complete 3 assessment questionnaires during an already-scheduled office visit. These questionnaires should take about 9 minutes to complete. Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. These questionnaires should take about 4 minutes to complete.
Other Names:
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant's Video Preference of Strategies in Introducing Psychology Services in a Palliative Care Setting
Time Frame: Day 1
|
Participants asked the preference to the introduction of counselor.
The possible answers are The First Video, The Second Video, Neither, or No Difference.
The actual content of the answers will be decoded by the study team at the end of the study to "Counselor Alone" or "MD + Counselor" depending on each patient's assigned arm.
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sujin Ann-Yi, PHD, MA, 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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0679
- NCI-2018-01285 (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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