Advanced Malignant NeoplasmNCT03856060
Videos and Questionnaires in Assessing Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits
A study testing Questionnaire Administration and Video in people with Advanced Malignant Neoplasm and Locally Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial assesses patient perception of physician's compassion, communication skills, and professionalism during clinic visits through the use of videos and questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Malignant Neoplasm
- What is being tested?
- Questionnaire Administration and Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2019to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of cancer either early disease or advanced cancer defined as locally advanced, recurrent or metastatic disease.
- Outpatients (either new referrals or follow-ups) seen in the Supportive Care Clinic.
- English speaking.
- Patients with normal cognitive status (Memorial Delirium Assessment Scale [MDAS] =< 6/30) who can understand the nature and purpose of the study and have the ability to complete the consent process.
Who cannot join
- Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be measured by the Edmonton Symptom Assessment Scale (ESAS) and Memorial Delirium Assessment Scale (MDAS), and will be determined by the principal investigator and/or attending physician who is caring for the patient during that visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits: a Randomized Controlled Trial (EHR Study #2)
This trial assesses patient perception of physician's compassion, communication skills, and professionalism during clinic visits through the use of videos and questionnaires.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare patients' perception of physicians' compassion after they watch the first scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
SECONDARY OBJECTIVES:
- To compare patients' perception of physicians' compassion after they watch the second scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
II. To compare patients' perception of physicians' communication skills after they watch each scripted-video vignettes of physicians: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
III. To compare patients' perception of physicians' professionalism after they watch each scripted-video vignettes of physicians: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
IV. To compare patients' perception of physicians' compassion, communication skills and professionalism after they watch two scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
- To compare patients' preference after they watch two scripted-video vignettes of physicians sequentially: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
VI. To examine patients' perception of EHR in healthcare delivery. VII. To establish demographic and clinical factors of patients preference for the physician.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients complete questionnaires and watch a video portraying a physician using a standard electronic health record (EHR) and then another portraying a physician using an integrated model of EHR during communication over 35 minutes.
GROUP II: Patients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes.
- Conditions
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
- Being tested
- Questionnaire Administration, Video
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Complete questionnaires
VideoOther
Watch videos of doctor and patient interaction in different settings
| Study group | Role | What they receive |
|---|---|---|
| Group I (questionnaires, videos) | Experimental | Patients complete questionnaires and watch a video portraying a physician using a standard EHR and then another portraying a physician using an integrated model of EHR during communication over 35 minutes. Receives: Other: Questionnaire Administration; Other: Video |
| Group II (video, questionnaire) | Experimental | Patients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes. Receives: Other: Questionnaire Administration; Other: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' perception of physicians' compassion after they watch the first video
Quantified by the total score of ratings from a comprehensive 5-item tool which assesses dimensions such as warm/cold, pleasant/unpleasant, compassionate/distant, sensitive/insensitive, and caring/uncaring (ranging from 0 to 10 for each item, and from 0 to 50 for the total score). Physicians' compassion, communication skills and professionalism will be compared between standard electronic health record (EHR) and integrated EHR groups at the end of each video using a two-sample t-test or Wilcoxon rank-sum test when appropriate. The mixed model will be applied to further explore the patterns of physicians' compassion, communication skills and professionalism from both videos. Patients' preference of physician and perception of EHR will be compared between standard EHR and integrated EHR groups using Chi-squared test or Fisher's exact test when appropriate. Logistic regression model will also be employed.
Measured: 1 year" or "up to 24 weeks", "through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start30 Mar 2019
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ali Haider, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856060
- Sponsor's protocol ID
- 2018-1016
- Other IDs
- NCI-2019-00508, 2018-1016, P30CA016672
- Status last verified
- Sep 2024
- First submitted
- 21 Feb 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During Clinic Visits: a Randomized Controlled Trial (EHR Study #2)
- ClinicalTrials.gov ID
- NCT03856060
- Acronym / sponsor ID
- 2018-1016
- Conditions
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial assesses patient perception of physician's compassion, communication skills, and professionalism during clinic visits through the use of videos and questionnaires.
Detailed description
PRIMARY OBJECTIVES:
- To compare patients' perception of physicians' compassion after they watch the first scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
SECONDARY OBJECTIVES:
- To compare patients' perception of physicians' compassion after they watch the second scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
II. To compare patients' perception of physicians' communication skills after they watch each scripted-video vignettes of physicians: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
III. To compare patients' perception of physicians' professionalism after they watch each scripted-video vignettes of physicians: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
IV. To compare patients' perception of physicians' compassion, communication skills and professionalism after they watch two scripted-video vignettes of physicians: one portraying a physician using a standard electronic health record (EHR) and the other one portraying a physician using an integrated model of EHR during communication.
- To compare patients' preference after they watch two scripted-video vignettes of physicians sequentially: one portraying a physician using a standard EHR and the other one portraying a physician using an integrated model of EHR during communication.
VI. To examine patients' perception of EHR in healthcare delivery. VII. To establish demographic and clinical factors of patients preference for the physician.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients complete questionnaires and watch a video portraying a physician using a standard electronic health record (EHR) and then another portraying a physician using an integrated model of EHR during communication over 35 minutes.
GROUP II: Patients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (questionnaires, videos) | Experimental | Other: Questionnaire Administration, Other: VideoPatients complete questionnaires and watch a video portraying a physician using a standard EHR and then another portraying a physician using an integrated model of EHR during communication over 35 minutes. |
| Group II (video, questionnaire) | Experimental | Other: Questionnaire Administration, Other: VideoPatients complete questionnaires and watch a video portraying a physician using an integrated model of EHR and then another portraying a physician using a standard EHR during communication over 35 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of cancer either early disease or advanced cancer defined as locally advanced, recurrent or metastatic disease.
- Outpatients (either new referrals or follow-ups) seen in the Supportive Care Clinic.
- English speaking.
- Patients with normal cognitive status (Memorial Delirium Assessment Scale [MDAS] =< 6/30) who can understand the nature and purpose of the study and have the ability to complete the consent process.
Key exclusion criteria (1 listed)
- Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be measured by the Edmonton Symptom Assessment Scale (ESAS) and Memorial Delirium Assessment Scale (MDAS), and will be determined by the principal investigator and/or attending physician who is caring for the patient during that visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationComplete questionnaires | Other | Group I (questionnaires, videos), Group II (video, questionnaire) |
| VideoWatch videos of doctor and patient interaction in different settings | Other | Group I (questionnaires, videos), Group II (video, questionnaire) |
Primary outcome
Patients' perception of physicians' compassion after they watch the first video
Time frame: 1 year" or "up to 24 weeks", "through study completion
Quantified by the total score of ratings from a comprehensive 5-item tool which assesses dimensions such as warm/cold, pleasant/unpleasant, compassionate/distant, sensitive/insensitive, and caring/uncaring (ranging from 0 to 10 for each item, and from 0 to 50 for the total score). Physicians' compassion, communication skills and professionalism will be compared between standard electronic health record (EHR) and integrated EHR groups at the end of each video using a two-sample t-test or Wilcoxon rank-sum test when appropriate. The mixed model will be applied to further explore the patterns of physicians' compassion, communication skills and professionalism from both videos. Patients' preference of physician and perception of EHR will be compared between standard EHR and integrated EHR groups using Chi-squared test or Fisher's exact test when appropriate. Logistic regression model will also be employed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Haider, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Video in people with Advanced Malignant Neoplasm and Locally Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' perception of physicians' compassion after they watch the first video (time frame: 1 year" or "up to 24 weeks", "through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.