Advanced CancersNCT02498899
Message 2: The Effect of Message Content and Clinical Outcome on Patient's Perception of Physician Compassion
A study testing Questionnaires and Video in people with Advanced Cancers, 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 view their doctor's compassion about 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
- Advanced Cancers
- What is being tested?
- Questionnaires and Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 6 Dec 2018
- 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
- Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
- Follow up patients seen in the outpatient Supportive Care Center.
- Age >/= 18 years-old
- English speaking
Who cannot join
- Altered cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
- Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation, as determined by the Principal Investigator or by the attending palliative care physician.
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
The goal of this research study is to learn how patients view their doctor's compassion about 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 the following:
- Basic information about you will be collected from your medical record (such as your date of birth, date of diagnosis, sex, and religion).
- You will complete 4 questionnaires about any symptoms you may be having, how hopeful you are in general, how you are dealing with the disease, your trust in the medical profession, and your strength of religious faith. It should take about 10 minutes total to complete all questionnaires.
You will then be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Each group will watch a short video that shows actors playing a doctor and patient having a conversation about different cancer treatment options. Each video is about 4 minutes long and will discuss the same material, but the message shown in the videos will be different for each group.
After you watch the video, you will complete 3 questionnaires that will ask about your impression of the doctor in the video, how hopeful you think the doctor was, if you think the doctor was professional, and how you would rate the doctor overall. It should take about 8 minutes total to complete all questionnaires.
You will then read a small story about the patient in the video. Afterwards, you will complete the same 3 questionnaires that you filled out after you watched the video. You will also complete an additional questionnaire about your impression of the doctor's compassion and trustworthiness. This should take less than 10 minutes to complete.
Length of Study:
It should take about 25 minutes total to watch the video and to complete all questionnaires. Your active participation on this study will be over after you have completed the last questionnaire.
Other Information:
You are taking part in this study alone. Your family members will not be in the room with you. If you request, your family may be able remain in the room, but the investigators ask that they remain silent.
This is an investigational study.
Up to 128 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Questionnaires, Video
- Keywords
- Advanced Cancers, Video, Questionnaires, Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Participants complete questionnaires at baseline, after watching a video, and after reading a story about the patient in the video.
VideoBehavioural
Participants watch a video lasting about 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Video 1 + Questionnaires | Experimental | Participants complete 4 questionnaires at baseline. Participants then watch a short video. At end of video, 3 questionnaires completed. Participants then read a small story about the patient in the video. Afterwards, another set of questionnaires completed. Receives: Behavioral: Questionnaires; Behavioral: Video |
| Video 2 + Questionnaires | Experimental | Participants complete 4 questionnaires at baseline. Participants then watch a short video. At end of video, 3 questionnaires completed. Participants then read a small story about the patient in the video. Afterwards, another set of questionnaires completed. Receives: Behavioral: Questionnaires; Behavioral: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of Physician's Compassion
Participant's rating of physician's compassion scored 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. Sum of the five scales gives a final score representing physician's compassion with a 0 to 50 scale.
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 posted15 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberson C. Tanco, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498899
- Sponsor's protocol ID
- 2015-0279
- Other IDs
- NCI-2015-01553
- Status last verified
- Mar 2019
- First submitted
- 13 Jul 2015
- Last updated
- 19 Mar 2019
- 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 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Message 2: The Effect of Message Content and Clinical Outcome on Patient's Perception of Physician Compassion
- ClinicalTrials.gov ID
- NCT02498899
- Acronym / sponsor ID
- 2015-0279
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Video, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 15 Jul 2015 (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 view their doctor's compassion about 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 the following:
- Basic information about you will be collected from your medical record (such as your date of birth, date of diagnosis, sex, and religion).
- You will complete 4 questionnaires about any symptoms you may be having, how hopeful you are in general, how you are dealing with the disease, your trust in the medical profession, and your strength of religious faith. It should take about 10 minutes total to complete all questionnaires.
You will then be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Each group will watch a short video that shows actors playing a doctor and patient having a conversation about different cancer treatment options. Each video is about 4 minutes long and will discuss the same material, but the message shown in the videos will be different for each group.
After you watch the video, you will complete 3 questionnaires that will ask about your impression of the doctor in the video, how hopeful you think the doctor was, if you think the doctor was professional, and how you would rate the doctor overall. It should take about 8 minutes total to complete all questionnaires.
You will then read a small story about the patient in the video. Afterwards, you will complete the same 3 questionnaires that you filled out after you watched the video. You will also complete an additional questionnaire about your impression of the doctor's compassion and trustworthiness. This should take less than 10 minutes to complete.
Length of Study:
It should take about 25 minutes total to watch the video and to complete all questionnaires. Your active participation on this study will be over after you have completed the last questionnaire.
Other Information:
You are taking part in this study alone. Your family members will not be in the room with you. If you request, your family may be able remain in the room, but the investigators ask that they remain silent.
This is an investigational study.
Up to 128 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Video 1 + Questionnaires | Experimental | Behavioral: Questionnaires, Behavioral: VideoParticipants complete 4 questionnaires at baseline. Participants then watch a short video. At end of video, 3 questionnaires completed. Participants then read a small story about the patient in the video. Afterwards, another set of questionnaires completed. |
| Video 2 + Questionnaires | Experimental | Behavioral: Questionnaires, Behavioral: VideoParticipants complete 4 questionnaires at baseline. Participants then watch a short video. At end of video, 3 questionnaires completed. Participants then read a small story about the patient in the video. Afterwards, another set of questionnaires completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
- Follow up patients seen in the outpatient Supportive Care Center.
- Age >/= 18 years-old
- English speaking
Key exclusion criteria (2 listed)
- Altered cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
- Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation, as determined by the Principal Investigator or by the attending palliative care physician.
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 |
|---|---|---|
| QuestionnairesAlso: SurveysParticipants complete questionnaires at baseline, after watching a video, and after reading a story about the patient in the video. | Behavioural | Video 1 + Questionnaires, Video 2 + Questionnaires |
| VideoParticipants watch a video lasting about 4 minutes. | Behavioural | Video 1 + Questionnaires, Video 2 + Questionnaires |
Primary outcome
Rating of Physician's Compassion
Time frame: 1 day
Participant's rating of physician's compassion scored 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. Sum of the five scales gives a final score representing physician's compassion with a 0 to 50 scale.
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 Mar 2019.
- 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.
Kimberson C. Tanco, 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 Questionnaires and Video in people with Advanced Cancers, 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 2 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 Mar 2019. 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?
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 19 Mar 2019.