Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Communication Strategies to Introduce Psychology Services

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035448
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Independent (Primary) Multiple Sites Behavioral: Questionnaires Other: Video Presentation Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Communication Strategies to Introduce Psychology Services in the Palliative Care Setting
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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.

Behavioral: Questionnaires

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 Name: Surveys

Other: Video Presentation
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.

Behavioral: Questionnaires

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 Name: Surveys

Other: Video Presentation
Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >/= 18 years-old
  2. Can speak, read, and understand English
  3. Diagnosis of locally advanced, recurrent, or metastatic disease
  4. Patients treated as outpatients by the supportive and palliative care team
  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. Previous psychological counseling received in supportive care department
  2. Patients with severe symptom distress as assessed by nursing staff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035448


Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Sujin Ann-Yi, PHD, MA M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03035448     History of Changes
Other Study ID Numbers: 2016-0679
NCI-2018-01285 ( Registry Identifier: NCI CTRP )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of independent (primary) multiple sites
Advanced cancer
Recurrent cancer
Metastatic disease
Palliative care
Videos
Questionnaires
Surveys

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms