Malignant Neoplasms of Independent (Primary) Multiple SitesNCT03115528
Difference in the Estimation of Prognosis
An observational study of Malignant Neoplasms of Independent (Primary) Multiple Sites, run by M.D. Anderson Cancer Center.
Trial summary
Objectives: Primary Objective: The primary objective is to identify the difference in the estimation of prognosis of advanced cancer patients between medical oncologists, gynecological oncologists, and palliative care physicians Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasms of Independent (Primary) Multiple Sites
- What is being tested?
- Estimation of Prognosis Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2017to Dec 2030
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical oncologists and palliative care physicians from UT MD Anderson Cancer Center
Who may be able to join
- Medical oncologists or gynecological who referred patients to the palliative care team; Palliative Care physicians to whom the patients were referred; Patients with locally advanced, metastatic, or, not curable cancer.
- 18 years old or older
Who cannot join
- N/A
About this study
Official title: What is the Difference in the Estimation of Prognosis of Advanced Cancer Patients Between Medical Oncologist, Gynecological Oncologists, and Palliative Care Physicians?
Objectives:
Primary Objective:
The primary objective is to identify the difference in the estimation of prognosis of advanced cancer patients between medical oncologists, gynecological oncologists, and palliative care physicians
Read the detailed description
The goal of this research study is to identify the difference in the estimation of prognosis of advanced cancer patients between medical or gynecological oncologists, and palliative care physicians. Up to 140 patients will be enrolled in this study.
- Being tested
- Estimation of Prognosis Questionnaire
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Medical oncologists, Palliative care physicians, Questionnaire, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimation of Prognosis QuestionnaireBehavioural
Also called Survey
Survey will examine two aspects of prognosis estimation: 1.) physician factors, 2.) prognosis estimation and contributing factors to patient prognosis. Survey will take approximately 5 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Medical Oncology Physicians | Medical oncology physicians are sent the Estimation of Prognosis questionnaire by email. Receives: Behavioral: Estimation of Prognosis Questionnaire | |
| Palliative Care Physicians | Palliative care physicians are sent the Estimation of Prognosis questionnaire by email. Receives: Behavioral: Estimation of Prognosis Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of Patient Overall Survival by Oncologists and by Palliative Care Physicians per Estimation of Prognosis Questionnaire
The answer to the question #4, "How long do you think this patient will live?" in the questionnaire is the primary endpoint.
Denoting the oncologist estimated OS time from the day of palliative care consult to death by TOnc, palliative care physician estimate by TPalliative, and the true OS time by T0, we define the accuracy of the estimation of OS by oncologists and by palliative care physician as ΔOnc = TOnc - T0 ΔPalliative = TPalliative - T0. And the difference between these two estimates is calculated as ΔOS = ΔOnc - ΔPalliative.
Based on the above formulas, ΔOS is actually calculated as (TOnc- TPalliative). The true survival time, T0, is cancelled out by the subtraction.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start14 Dec 2017
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: Terminated at Continuing Review
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelique N. Wong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115528
- Sponsor's protocol ID
- 2016-0879
- Status last verified
- May 2019
- First submitted
- 6 Apr 2017
- Last updated
- 22 May 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 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Difference in the Estimation of Prognosis of Advanced Cancer Patients Between Medical Oncologist, Gynecological Oncologists, and Palliative Care Physicians?
- ClinicalTrials.gov ID
- NCT03115528
- Acronym / sponsor ID
- 2016-0879
- Keywords
- Malignant neoplasms of independent (primary) multiple sites, Medical oncologists, Palliative care physicians, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Terminated at Continuing Review
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 14 Apr 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.
Objectives:
Primary Objective:
The primary objective is to identify the difference in the estimation of prognosis of advanced cancer patients between medical oncologists, gynecological oncologists, and palliative care physicians
Detailed description
The goal of this research study is to identify the difference in the estimation of prognosis of advanced cancer patients between medical or gynecological oncologists, and palliative care physicians. Up to 140 patients will be enrolled in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Oncology Physicians | – | Behavioral: Estimation of Prognosis QuestionnaireMedical oncology physicians are sent the Estimation of Prognosis questionnaire by email. |
| Palliative Care Physicians | – | Behavioral: Estimation of Prognosis QuestionnairePalliative care physicians are sent the Estimation of Prognosis questionnaire by email. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical oncologists and palliative care physicians from UT MD Anderson Cancer Center
Key inclusion criteria (2 listed)
- Medical oncologists or gynecological who referred patients to the palliative care team; Palliative Care physicians to whom the patients were referred; Patients with locally advanced, metastatic, or, not curable cancer.
- 18 years old or older
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Estimation of Prognosis QuestionnaireAlso: SurveySurvey will examine two aspects of prognosis estimation: 1.) physician factors, 2.) prognosis estimation and contributing factors to patient prognosis. Survey will take approximately 5 minutes to complete. | Behavioural | Medical Oncology Physicians, Palliative Care Physicians |
Primary outcome
Estimation of Patient Overall Survival by Oncologists and by Palliative Care Physicians per Estimation of Prognosis Questionnaire
Time frame: 6 weeks
The answer to the question #4, "How long do you think this patient will live?" in the questionnaire is the primary endpoint. Denoting the oncologist estimated OS time from the day of palliative care consult to death by TOnc, palliative care physician estimate by TPalliative, and the true OS time by T0, we define the accuracy of the estimation of OS by oncologists and by palliative care physician as ΔOnc = TOnc - T0 ΔPalliative = TPalliative - T0. And the difference between these two estimates is calculated as ΔOS = ΔOnc - ΔPalliative. Based on the above formulas, ΔOS is actually calculated as (TOnc- TPalliative). The true survival time, T0, is cancelled out by the subtraction.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Malignant Neoplasms of Independent (Primary) Multiple Sites
Active, not recruitingObservational study
Expectations Regarding Mobility and Self-Care
Benign Neoplasms, Malignant Neoplasms of Independent (Primary) Multiple Sites
RecruitingPhase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
Malignant Neoplasm of Bone and Articular Cartilage, Malignant Neoplasms of Female Genital Organs
Active, not recruitingPhase 1
Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT
Malignant Neoplasm of Breast, Malignant Neoplasms of Digestive Organs
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.
Angelique N. Wong, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasms of Independent (Primary) Multiple Sites, run by M.D. Anderson Cancer Center.
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 2 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: withdrawn, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Estimation of Patient Overall Survival by Oncologists and by Palliative Care Physicians per Estimation of Prognosis Questionnaire (time frame: 6 weeks). 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 22 May 2019.