Malignant Neoplasms of Independent (Primary) Multiple SitesNCT03168763
Effect of Physician Attire on Patients' Preference of Physician
A study testing Video and Questionnaires in people with Malignant Neoplasms of Independent (Primary) Multiple Sites, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn about the effects of a doctor's characteristics on participant's preference for a doctor. Researchers also want to learn about how a doctor's characteristics affect participant's options about professionalism and compassion. 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
- What is being tested?
- Video and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 26 Oct 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
- Advanced cancer diagnosis (locally advanced, recurrent or metastatic disease).
- Patients presenting as follow-ups only at the outpatient Supportive Care Center.
- Age >/= 18 years-old
- English speaking
Who cannot join
- Altered cognition (as assessed routinely in the Supportive Care Clinic using the Memorial Delirium Assessment Scale (MDAS), with a score of >/= 7/30).
- Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation.
- Patients with hearing and/or visual impairments.
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: Advanced Cancer Patients' Perception of Physician Compassion and Professionalism - A Randomized, Double Blind, Cross Over Trial
The goal of this research study is to learn about the effects of a doctor's characteristics on participant's preference for a doctor. Researchers also want to learn about how a doctor's characteristics affect participant's options about professionalism and compassion.
Read the detailed description
If participant agrees to take part in this study, participant will be asked to complete 7 questionnaires. These questionnaires ask about participant's gender, date of birth, ethnicity, marital status, level of education, religion, and information about the disease and treatments participant received. Participant will also be asked about any symptoms participant may be having, how much trust participant has in the medical profession in general, how participant feels about the disease, any depression or anxiety participant may have, and participant's level of hopefulness. These questionnaires should take about 6 minutes to complete.
Participant will be shown 2 videos (each 3 minutes long) and then participant will complete questions about each video. Participant will be asked to rate the doctors participant saw on their professionalism and their compassion.
Caregivers will be required to leave the room or stay silent while the participant is watching the videos.
The total time to watch the videos and complete the second set of questionnaires should be about 7 minutes.
Finally, participant will be asked to complete 3 questionnaires about participant's overall preference for a doctor. These questionnaires will take about 5 minutes to complete.
Length of Study Participation:
Participation in this study is complete after participant answers the final questionnaires.
Overall, this study should take about 30 minutes to complete.
This is an investigational study.
Up to 108 participants will be enrolled in this study. All will take part at MD Anderson.
- Being tested
- Video, Questionnaires
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Advanced Cancer, Videos, Questionnaires, Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
Participants shown Video 1A or 1B, then shown Video 2A or 2B.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline, after each video viewing, and at completion.
| Study group | Role | What they receive |
|---|---|---|
| Video 1A | Experimental | Questionnaires completed at baseline, after each video viewing, and at completion.
Participants shown Video 1A or 1B, then shown Video 2A or 2B. Receives: Behavioral: Video; Behavioral: Questionnaires |
| Video 1B | Experimental | Questionnaires completed at baseline, after each video viewing, and at completion.
Participants shown Video 1A or 1B, then shown Video 2A or 2B. Receives: Behavioral: Video; Behavioral: Questionnaires |
| Video 2A | Experimental | Questionnaires completed at baseline, after each video viewing, and at completion.
Participants shown Video 1A or 1B, then shown Video 2A or 2B. Receives: Behavioral: Video; Behavioral: Questionnaires |
| Video 2B | Experimental | Questionnaires completed at baseline, after each video viewing, and at completion.
Participants shown Video 1A or 1B, then shown Video 2A or 2B. Receives: Behavioral: Video; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's Perception of Physician's Compassion
Participant's rating of physician's compassion assessed by using a validated 5-item tool consisting of five 0-10 numerical rating scales assessing five dimensions: warm-cold, pleasant-unpleasant, compassionate- distant, sensitive- insensitive, and caring-uncaring.
The sum of the five scales gives a final score representing physician's compassion on a scale of 0 to 50.
Measured: 1 day
Secondary outcomes (1)
Participant's Perception of Physician's Professionalism
Participant's rating of physician's professionalism assessed by using a validated 4-item tool assessing politeness, listening, explaining the condition and treatment to the patient and patient's involvement in treatment decisions. Participant rates from poor-1 to very good-5.
The sum of these 4 items gives a final score representing physician's level of professionalism on a scale of 4 to 20.
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 posted30 May 2017
- Study start25 Sep 2017
- Primary completion26 Oct 2020
- Study completion26 Oct 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahsan Azhar, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168763
- Sponsor's protocol ID
- 2016-0970
- Other IDs
- NCI-2018-01195
- Status last verified
- Nov 2020
- First submitted
- 25 May 2017
- Last updated
- 13 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Cancer Patients' Perception of Physician Compassion and Professionalism - A Randomized, Double Blind, Cross Over Trial
- ClinicalTrials.gov ID
- NCT03168763
- Acronym / sponsor ID
- 2016-0970
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Advanced Cancer, Videos, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 30 May 2017 (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.
The goal of this research study is to learn about the effects of a doctor's characteristics on participant's preference for a doctor. Researchers also want to learn about how a doctor's characteristics affect participant's options about professionalism and compassion.
Detailed description
If participant agrees to take part in this study, participant will be asked to complete 7 questionnaires. These questionnaires ask about participant's gender, date of birth, ethnicity, marital status, level of education, religion, and information about the disease and treatments participant received. Participant will also be asked about any symptoms participant may be having, how much trust participant has in the medical profession in general, how participant feels about the disease, any depression or anxiety participant may have, and participant's level of hopefulness. These questionnaires should take about 6 minutes to complete.
Participant will be shown 2 videos (each 3 minutes long) and then participant will complete questions about each video. Participant will be asked to rate the doctors participant saw on their professionalism and their compassion.
Caregivers will be required to leave the room or stay silent while the participant is watching the videos.
The total time to watch the videos and complete the second set of questionnaires should be about 7 minutes.
Finally, participant will be asked to complete 3 questionnaires about participant's overall preference for a doctor. These questionnaires will take about 5 minutes to complete.
Length of Study Participation:
Participation in this study is complete after participant answers the final questionnaires.
Overall, this study should take about 30 minutes to complete.
This is an investigational study.
Up to 108 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Video 1A | Experimental | Behavioral: Video, Behavioral: QuestionnairesQuestionnaires completed at baseline, after each video viewing, and at completion. Participants shown Video 1A or 1B, then shown Video 2A or 2B. |
| Video 1B | Experimental | Behavioral: Video, Behavioral: QuestionnairesQuestionnaires completed at baseline, after each video viewing, and at completion. Participants shown Video 1A or 1B, then shown Video 2A or 2B. |
| Video 2A | Experimental | Behavioral: Video, Behavioral: QuestionnairesQuestionnaires completed at baseline, after each video viewing, and at completion. Participants shown Video 1A or 1B, then shown Video 2A or 2B. |
| Video 2B | Experimental | Behavioral: Video, Behavioral: QuestionnairesQuestionnaires completed at baseline, after each video viewing, and at completion. Participants shown Video 1A or 1B, then shown Video 2A or 2B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced cancer diagnosis (locally advanced, recurrent or metastatic disease).
- Patients presenting as follow-ups only at the outpatient Supportive Care Center.
- Age >/= 18 years-old
- English speaking
Key exclusion criteria (3 listed)
- Altered cognition (as assessed routinely in the Supportive Care Clinic using the Memorial Delirium Assessment Scale (MDAS), with a score of >/= 7/30).
- Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation.
- Patients with hearing and/or visual impairments.
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 |
|---|---|---|
| VideoParticipants shown Video 1A or 1B, then shown Video 2A or 2B. | Behavioural | Video 1A, Video 1B, Video 2A, Video 2B |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline, after each video viewing, and at completion. | Behavioural | Video 1A, Video 1B, Video 2A, Video 2B |
Primary outcome
Participant's Perception of Physician's Compassion
Time frame: 1 day
Participant's rating of physician's compassion assessed by using a validated 5-item tool consisting of five 0-10 numerical rating scales assessing five dimensions: warm-cold, pleasant-unpleasant, compassionate- distant, sensitive- insensitive, and caring-uncaring. The sum of the five scales gives a final score representing physician's compassion on a scale of 0 to 50.
1 secondary outcome
Participant's Perception 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 13 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.
Ahsan Azhar, 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 Video and Questionnaires in people with Malignant Neoplasms of Independent (Primary) Multiple Sites, 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 3 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 13 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 Perception 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 13 Nov 2020.