NCT02957565

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration 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

Study Start

First participant enrolled

November 3, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

November 4, 2016

Last Update Submit

November 23, 2020

Conditions

Keywords

Malignant neoplasms of independent (primary) multiple sitesQuestionnairesSurveysVideosAdvanced Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Participant's Rating of Physician Communication Skills

    1 day

  • Participant's Rating of Physician's Professionalism

    1 day

Study Arms (4)

Video 1: No EHR - Physician A

EXPERIMENTAL

Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires.

Behavioral: Baseline QuestionnairesOther: VideosBehavioral: Assessment Questionnaires

Video 1: No EHR - Physician B

EXPERIMENTAL

Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires.

Behavioral: Baseline QuestionnairesOther: VideosBehavioral: Assessment Questionnaires

Video 2: With EHR - Physician A

EXPERIMENTAL

Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires.

Behavioral: Baseline QuestionnairesOther: VideosBehavioral: Assessment Questionnaires

Video 2: With EHR - Physician B

EXPERIMENTAL

Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires.

Behavioral: Baseline QuestionnairesOther: VideosBehavioral: Assessment Questionnaires

Interventions

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.

Also known as: Surveys
Video 1: No EHR - Physician AVideo 1: No EHR - Physician BVideo 2: With EHR - Physician AVideo 2: With EHR - Physician B
VideosOTHER

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.

Video 1: No EHR - Physician AVideo 1: No EHR - Physician BVideo 2: With EHR - Physician AVideo 2: With EHR - Physician B

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.

Also known as: Surveys
Video 1: No EHR - Physician AVideo 1: No EHR - Physician BVideo 2: With EHR - Physician AVideo 2: With EHR - Physician B

Eligibility Criteria

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

You may qualify if:

  • Patients with the diagnosis of advanced cancer defined as locally advanced, recurrent or metastatic disease.
  • Outpatients (either new referrals or follow ups) seen in the Supportive Care Clinic.
  • Age \>/= 18 years old
  • English speaking
  • 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.

You may not qualify if:

  • \) 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.

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

Interventions

Surveys and QuestionnairesVideotape Recording

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthTape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Ali Haider, MBBS

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 7, 2016

Study Start

November 3, 2016

Primary Completion

January 2, 2020

Study Completion

January 2, 2020

Last Updated

November 25, 2020

Record last verified: 2020-11

Locations