Advanced CancerNCT02357108
Message: Study of Patients' Perception of Physician's Compassion
A study testing Video and Survey in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to learn what types of conversations patients prefer to have with their doctor about treatment options and how patients view their doctor's compassion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Video and Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2015
- 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
- Patients treated as outpatients by the Supportive and Palliative Care team.
- Age >/= 18 years-old
- English speaking
- Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
Who cannot join
- 1) 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
Official title: A Trial on Patient's Evaluation of a Physician Conveying Two Different Messages
The goal of this study is to learn what types of conversations patients prefer to have with their doctor about treatment options and how patients view their doctor's compassion.
Read the detailed description
If participant agree to take part in the study, basic information will be collected (such as date of birth, date of diagnosis, sex, and religion). Participant will also complete questionnaires about any symptoms they may be having, how hopeful they are, how they are accepting the disease, their trust in the medical profession, and how they like information to be delivered to them.
After completing the questionnaires, they will be randomly assigned (as the roll of dice) to one of 4 groups.
Regardless of which group they are in, they will watch 2 short videos that show actors portraying a doctor and patient having a conversation about treatment options in a clinical setting. Both videos will discuss the same material, but the order of the videos and the actors in the videos will be different for each group. Both videos are about 4 minutes long.
After watching each video, the participant will complete 3 questionnaires about the doctor in the video. It should take about 38 minutes to watch both videos and to complete all of the questionnaires.
After they have watched both videos, they will be asked to choose which doctor they preferred and to briefly explain the reasons why they chose that doctor.
Length of Study:
Participant will be off study after they have completed the last questionnaire.
- Conditions
- Advanced Cancer
- Being tested
- Video, Survey
- Keywords
- Supportive Care, treatment options, doctor's compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
Watch two short videos with a 4-minute interval between the two of them, estimate 8 minutes to watch both the videos.
SurveyBehavioural
Also called Survey Questionnaires, questionnaire
One set of surveys before first video and one set after each video played, estimate total of 30 minutes for all surveys.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Video/Doctor Sequence 1 | Active comparator | Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video) Receives: Other: Video; Behavioral: Survey |
| Group 2: Video/Doctor Sequence 2 | Active comparator | Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video) Receives: Other: Video; Behavioral: Survey |
| Group 3: Video/Doctor Sequence 3 | Active comparator | Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video) Receives: Other: Video; Behavioral: Survey |
| Group 4: Video/Doctor Sequence 4 | Active comparator | Participants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video) Receives: Other: Video; Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's Rating of Physician's Compassion
Physician compassion tested using compassion data from the first video viewed by each patient as assessed by a Physician Compassion Assessment survey. Patient's rating of physician's compassion 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 will give a final score representing physician's compassion with a 0 to 50 scale.
Measured: Approximately 38 minutes for video viewing and surveys.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startMay 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 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, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357108
- Sponsor's protocol ID
- 2012-0113
- Other IDs
- NCI-2015-01419
- Status last verified
- Jul 2016
- First submitted
- 29 Jan 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Tanco K, Rhondali W, Perez-Cruz P, Tanzi S, Chisholm GB, Baile W, Frisbee-Hume S, Williams J, Masino C, Cantu H, Sisson A, Arthur J, Bruera E. Patient Perception of Physician Compassion After a More Optimistic vs a Less Optimistic Message: A Randomized Clinical Trial. JAMA Oncol. 2015 May;1(2):176-83. doi: 10.1001/jamaoncol.2014.297.
PubMed 26181019
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial on Patient's Evaluation of a Physician Conveying Two Different Messages
- ClinicalTrials.gov ID
- NCT02357108
- Acronym / sponsor ID
- 2012-0113
- Conditions
- Advanced Cancer
- Keywords
- Supportive Care, treatment options, doctor's compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Feb 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 study is to learn what types of conversations patients prefer to have with their doctor about treatment options and how patients view their doctor's compassion.
Detailed description
If participant agree to take part in the study, basic information will be collected (such as date of birth, date of diagnosis, sex, and religion). Participant will also complete questionnaires about any symptoms they may be having, how hopeful they are, how they are accepting the disease, their trust in the medical profession, and how they like information to be delivered to them.
After completing the questionnaires, they will be randomly assigned (as the roll of dice) to one of 4 groups.
Regardless of which group they are in, they will watch 2 short videos that show actors portraying a doctor and patient having a conversation about treatment options in a clinical setting. Both videos will discuss the same material, but the order of the videos and the actors in the videos will be different for each group. Both videos are about 4 minutes long.
After watching each video, the participant will complete 3 questionnaires about the doctor in the video. It should take about 38 minutes to watch both videos and to complete all of the questionnaires.
After they have watched both videos, they will be asked to choose which doctor they preferred and to briefly explain the reasons why they chose that doctor.
Length of Study:
Participant will be off study after they have completed the last questionnaire.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Video/Doctor Sequence 1 | Active comparator | Other: Video, Behavioral: SurveyParticipants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video) |
| Group 2: Video/Doctor Sequence 2 | Active comparator | Other: Video, Behavioral: SurveyParticipants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video) |
| Group 3: Video/Doctor Sequence 3 | Active comparator | Other: Video, Behavioral: SurveyParticipants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video) |
| Group 4: Video/Doctor Sequence 4 | Active comparator | Other: Video, Behavioral: SurveyParticipants watch two videos with varying video/doctor sequence and complete 3 surveys (one before the first video and one survey after each video) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
- Patients treated as outpatients by the Supportive and Palliative Care team.
- Age >/= 18 years-old
- English speaking
- Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.
Key exclusion criteria (1 listed)
- 1) 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 |
|---|---|---|
| VideoWatch two short videos with a 4-minute interval between the two of them, estimate 8 minutes to watch both the videos. | Other | Group 1: Video/Doctor Sequence 1, Group 2: Video/Doctor Sequence 2, Group 3: Video/Doctor Sequence 3, Group 4: Video/Doctor Sequence 4 |
| SurveyAlso: Survey Questionnaires, questionnaireOne set of surveys before first video and one set after each video played, estimate total of 30 minutes for all surveys. | Behavioural | Group 1: Video/Doctor Sequence 1, Group 2: Video/Doctor Sequence 2, Group 3: Video/Doctor Sequence 3, Group 4: Video/Doctor Sequence 4 |
Primary outcome
Participant's Rating of Physician's Compassion
Time frame: Approximately 38 minutes for video viewing and surveys.
Physician compassion tested using compassion data from the first video viewed by each patient as assessed by a Physician Compassion Assessment survey. Patient's rating of physician's compassion 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 will give 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 15 Jul 2016.
- Derived from this study: PubMed 26181019Tanco K, Rhondali W, Perez-Cruz P, Tanzi S, Chisholm GB, Baile W, Frisbee-Hume S, Williams J, Masino C, Cantu H, Sisson A, Arthur J, Bruera E. Patient Perception of Physician Compassion After a More Optimistic vs a Less Optimistic Message: A Randomized Clinical Trial. JAMA Oncol. 2015 May;1(2):176-83. doi: 10.1001/jamaoncol.2014.297.
- University of Texas MD Anderson Cancer Center Official 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 study chair
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 Survey in people with 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 15 Jul 2016. 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: Approximately 38 minutes for video viewing and surveys.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02357108, which also lists 1 linked publication.
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 15 Jul 2016.