NCT03035448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

6.7 years

First QC Date

January 26, 2017

Last Update Submit

October 11, 2023

Conditions

Malignant Neoplasms of Independent (Primary) Multiple Sites

Keywords

Malignant neoplasms of independent (primary) multiple sitesAdvanced cancerRecurrent cancerMetastatic diseasePalliative careVideosQuestionnairesSurveys

Outcome Measures

Primary Outcomes (1)

  • Participant's Video Preference of Strategies in Introducing Psychology Services in a Palliative Care Setting

    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

Study Arms (2)

Video 1: Counselor Alone

EXPERIMENTAL

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: QuestionnairesOther: Video Presentation

Video 2: Doctor + Counselor

EXPERIMENTAL

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: QuestionnairesOther: Video Presentation

Interventions

QuestionnairesBEHAVIORAL

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.

Also known as: Surveys
Video 1: Counselor AloneVideo 2: Doctor + Counselor
Video PresentationOTHER

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

Video 1: Counselor AloneVideo 2: Doctor + Counselor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous psychological counseling received in supportive care department
  • Patients with severe symptom distress as assessed by nursing staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

RecurrenceNeoplasm Metastasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic ProcessesNeoplasms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sujin Ann-Yi, PHD, MA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

February 13, 2017

Primary Completion

October 10, 2023

Study Completion

October 10, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

US(1)