Communication Strategies to Introduce Psychology Services

October 11, 2023 updated by: M.D. Anderson Cancer Center

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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 Names:
  • 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 Names:
  • Surveys
Other: Video Presentation
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

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Sujin Ann-Yi, PHD, MA, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2017

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimated)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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