Malignant Neoplasms of Independent (Primary) Multiple SitesNCT02957565
Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During an Outpatient Palliative Care Visit
A study testing Baseline Questionnaires, Videos and Assessment Questionnaires in people with Malignant Neoplasms of Independent (Primary) Multiple Sites and Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Independent (Primary) Multiple Sites, Advanced Cancer
- What is being tested?
- Baseline Questionnaires, Videos and Assessment Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2016to 2 Jan 2020
- 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 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.
Who cannot join
- 1) 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During an Outpatient Palliative Care Visit: A Randomized Controlled Trial
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.
Read the detailed description
If you agree to take part in this study, during an already-scheduled office visit, you will complete 5 questionnaires about your symptoms, your physical and emotional health, and your trust in the medical profession. These questionnaires should take about 17 minutes to complete.
Study Groups:
After you have completed the first 5 questionnaires, you will be randomly assigned (as in the roll of the dice) to 1 of 4 groups.
Each group will watch 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 will discuss the same content, but setting of each video will be different.
After watching the first video, you will complete 3 questionnaires about your opinions of the doctor's behavior. These questionnaires should take about 5 minutes to complete.
After you watch the second video, you will complete the same 3 questionnaires. You will also complete 2 additional questionnaires about which doctor you would rather have as your doctor and why, and your opinion about the setting of the examination room in the video. It should take about 8 minutes to complete these questionnaires.
Length of Study:
It should take about 38 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:
You must attend the study visit alone. Your family members should not be in the room with you while you are participating in the study. You may request to have family members remain in the room, but they must remain silent so that they do not influence your opinions.
This is an investigational study.
Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
- Being tested
- Baseline Questionnaires, Videos, Assessment Questionnaires
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Questionnaires, Surveys, Videos, Advanced Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline QuestionnairesBehavioural
Also called Surveys
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.
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.
Assessment QuestionnairesBehavioural
Also called Surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Baseline Questionnaires; Other: Videos; Behavioral: 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. Receives: Behavioral: Baseline Questionnaires; Other: Videos; Behavioral: 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. Receives: Behavioral: Baseline Questionnaires; Other: Videos; Behavioral: 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. Receives: Behavioral: Baseline Questionnaires; Other: Videos; Behavioral: Assessment Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
Participant's Rating of Physician Communication Skills
Participant's rating of physician communication skills assessed by using a 14-item tool consisting of 1 to 4 numerical rating scales assessing communication skills. The sum of these 14 scales gives a final score representing physician's communication skills with a 14 to 70 scale.
Measured: 1 day
Participant's Rating of Physician's Professionalism
Participant's rating of physician's professionalism assessed by using a 4-item tool assessing politeness, listening, explaining the condition and treatment to the participant and participant's involvement in treatment decisions. Participant rates from poor to very good.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start3 Nov 2016
- Primary completion2 Jan 2020
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Independent (Primary) Multiple SitesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Haider, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957565
- Sponsor's protocol ID
- 2016-0494
- Other IDs
- NCI-2017-00621
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2016
- Last updated
- 25 Nov 2020
- 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 25 Nov 2020. 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 an Outpatient Palliative Care Visit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02957565
- Acronym / sponsor ID
- 2016-0494
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Questionnaires, Surveys, Videos, Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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.
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.
Detailed description
If you agree to take part in this study, during an already-scheduled office visit, you will complete 5 questionnaires about your symptoms, your physical and emotional health, and your trust in the medical profession. These questionnaires should take about 17 minutes to complete.
Study Groups:
After you have completed the first 5 questionnaires, you will be randomly assigned (as in the roll of the dice) to 1 of 4 groups.
Each group will watch 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 will discuss the same content, but setting of each video will be different.
After watching the first video, you will complete 3 questionnaires about your opinions of the doctor's behavior. These questionnaires should take about 5 minutes to complete.
After you watch the second video, you will complete the same 3 questionnaires. You will also complete 2 additional questionnaires about which doctor you would rather have as your doctor and why, and your opinion about the setting of the examination room in the video. It should take about 8 minutes to complete these questionnaires.
Length of Study:
It should take about 38 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:
You must attend the study visit alone. Your family members should not be in the room with you while you are participating in the study. You may request to have family members remain in the room, but they must remain silent so that they do not influence your opinions.
This is an investigational study.
Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Video 1: No EHR - Physician A | Experimental | Behavioral: Baseline Questionnaires, Other: Videos, Behavioral: Assessment QuestionnairesParticipant 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. |
| Video 1: No EHR - Physician B | Experimental | Behavioral: Baseline Questionnaires, Other: Videos, Behavioral: Assessment QuestionnairesParticipant 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. |
| Video 2: With EHR - Physician A | Experimental | Behavioral: Baseline Questionnaires, Other: Videos, Behavioral: Assessment QuestionnairesParticipant 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. |
| Video 2: With EHR - Physician B | Experimental | Behavioral: Baseline Questionnaires, Other: Videos, Behavioral: Assessment QuestionnairesParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) 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.
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 |
|---|---|---|
| Baseline QuestionnairesAlso: SurveysParticipant 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. | Behavioural | Video 1: No EHR - Physician A, Video 1: No EHR - Physician B, Video 2: With EHR - Physician A, Video 2: With EHR - Physician B |
| VideosParticipant 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. | Other | Video 1: No EHR - Physician A, Video 1: No EHR - Physician B, Video 2: With EHR - Physician A, Video 2: With EHR - Physician B |
| Assessment QuestionnairesAlso: SurveysAfter 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. | Behavioural | Video 1: No EHR - Physician A, Video 1: No EHR - Physician B, Video 2: With EHR - Physician A, Video 2: With EHR - Physician B |
Primary outcome
Participant's Rating of Physician's Compassion
Time frame: 1 day
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.
2 secondary outcomes
Participant's Rating of Physician Communication Skills
Time frame: 1 day
Participant's Rating of Physician's Professionalism
Time frame: 1 day
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 25 Nov 2020.
- University of Texas 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, MBBS 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 Baseline Questionnaires, Videos and Assessment Questionnaires in people with Malignant Neoplasms of Independent (Primary) Multiple Sites and Advanced Cancer, 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 5 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 25 Nov 2020. 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?
Participant's Rating of Physician's Compassion (time frame: 1 day). 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 25 Nov 2020.