Advanced CancerNCT01358110
Emergency Department-Based Palliative Care for Advanced Cancer Patients
A study testing Early palliative care consultation and Care as usual in people with Advanced Cancer and Metastatic Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer
- What is being tested?
- Early palliative care consultation and Care as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jan 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
- ≥ 18 years age
- Speak English or Spanish
- ED patient with an advanced solid malignancy
Who cannot join
- Have already been seen by palliative care team
- Cognitive deficits
- Children or adolescents
- No confirmed history of active cancer
- Do not speak English or Spanish
- Reside outside the US
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.
Read the detailed description
As the population ages, the number of individual living with cancer will continue to rise, and the number of Emergency Department (ED) visits for this population will continue to increase. Cancer patients visit EDs because symptoms, such as pain or vomiting, can't be controlled at home, in an assisted living facility, or in their provider's office. The ED is often the only place that can provide the necessary treatments as well as immediate access to technologically advanced testing for those with cancer. However, palliative care (PC) services, such as relief of burdensome symptoms), attention to spiritual or social concerns, and establishing goals of care, is not standard care in the ED outside of a few medical centers. Most patients do not have well-defined goals of care, and are often subjected to painful and marginally effective tests and procedures, not because they are consistent with their goals but because it is less time-consuming than discussing other options and has less perceived legal risk. Until recently little emphasis has been placed on education, research, or guidelines for the delivery of PC services in this important setting. While emergency providers could provide some of these services themselves, knowledge and skills regarding PC as well as staffing are currently inadequate to provide comprehensive services. In addition to further decreasing days spent in the hospital and health care costs, consultation by a PC team for ED cancer patients might also reduce pain and other symptoms, aid in complex medical decision-making regarding testing and treatments, and facilitate transfer to hospice or home with visiting nurse services. To enable PC consultation for ED cancer patients, the investigators will first determine who could benefit from emergent consultation, what services they need, and what characteristics of emergency providers and hospitals are preventing them from being offered. To determine what affect PC consultation for patients with advanced cancer has on symptoms, discussions with patients and families about goals of care, and how long patients spend in the ED, the investigators will then randomly assign 200 ED cancer patients to targeted PC consultation versus usual or standard care.
- Conditions
- Advanced Cancer, Metastatic Cancer
- Being tested
- Early palliative care consultation, Care as usual
- Keywords
- palliative care, cancer, emergency medicine, end- of- life care
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early palliative care consultationOther
Patients will have symptoms assessed, have goals of care discussion with family and team present, and surrogate designated, as well as coordination of care and home services.
Care as usualOther
Standard care as usual which may or may not include palliative care consultation
| Study group | Role | What they receive |
|---|---|---|
| Early palliative care consultation | Experimental | Early palliative care consultation for ED patients with advanced cancer. Receives: Other: Early palliative care consultation |
| Care as usual | Other | Care as usual, may or may not receive palliative care consultation Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Comparison of life and quality of mental health from baseline to 6 weeks and 12 weeks.
Measured: at baseline, 6 weeks and 12 weeks
Secondary outcomes (5)
Inpatient costs per day/cost of stay during hospitalization
Costs per day during incident admission and total cost of entire incident hospital stay
Measured: 6 months after hospital discharge
Hospital length of stay
Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates.
Measured: 6 months after hospital discharge
Survival
Survival days from day of enrollment to day of death or study termination
Measured: at time of enrollment
Readmissions within 6 months of discharge
Measured: 6 months from hospital discharge
Repeat visits to the ED in 6 months
Measured: 6 months from hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (88)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 Icahn School of Medicine at Mount SinaiThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Corita Grudzen, MD, MSHS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358110
- Sponsor's protocol ID
- GCO 08-1234
- Status last verified
- Jun 2015
- First submitted
- 19 May 2011
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wiencke JK, Zheng S, Lafuente A, Lafuente MJ, Grudzen C, Wrensch MR, Miike R, Ballesta A, Trias M. Aberrant methylation of p16INK4a in anatomic and gender-specific subtypes of sporadic colorectal cancer. Cancer Epidemiol Biomarkers Prev. 1999 Jun;8(6):501-6.
PubMed 10385139Grudzen CR, Liddicoat R, Hoffman JR, Koenig W, Lorenz KA, Asch SM. Developing quality indicators for the appropriateness of resuscitation in prehospital atraumatic cardiac arrest. Prehosp Emerg Care. 2007 Oct-Dec;11(4):434-42. doi: 10.1080/10903120701536925.
PubMed 17907029Chan GK. End-of-life models and emergency department care. Acad Emerg Med. 2004 Jan;11(1):79-86. doi: 10.1197/j.aem.2003.07.019.
PubMed 14709435McCusker J, Karp I, Cardin S, Durand P, Morin J. Determinants of emergency department visits by older adults: a systematic review. Acad Emerg Med. 2003 Dec;10(12):1362-70. doi: 10.1111/j.1553-2712.2003.tb00011.x.
PubMed 14644789Burge F, Lawson B, Johnston G. Family physician continuity of care and emergency department use in end-of-life cancer care. Med Care. 2003 Aug;41(8):992-1001. doi: 10.1097/00005650-200308000-00012.
PubMed 12886178A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.
PubMed 7474243Mohanty SA SS, Bodukum VK,Grudzen CR, Lorenz K, Asch SM. Assessing the Need for Integration of Palliative Care in a Public Sector Emergency Department. Paper presented at: Academy Health2008; Washington D.C.
Mahony SO, Blank A, Simpson J, Persaud J, Huvane B, McAllen S, Davitt M, McHugh M, Hutcheson A, Karakas S, Higgins P, Selwyn P. Preliminary report of a palliative care and case management project in an emergency department for chronically ill elderly patients. J Urban Health. 2008 May;85(3):443-51. doi: 10.1007/s11524-008-9257-z.
PubMed 18363108Alpert HR, Emanuel L. Comparing utilization of life-sustaining treatments with patient and public preferences. J Gen Intern Med. 1998 Mar;13(3):175-81. doi: 10.1046/j.1525-1497.1998.00052.x.
PubMed 9541374Marco CA, Bessman ES, Schoenfeld CN, Kelen GD. Ethical issues of cardiopulmonary resuscitation: current practice among emergency physicians. Acad Emerg Med. 1997 Sep;4(9):898-904. doi: 10.1111/j.1553-2712.1997.tb03816.x.
PubMed 9305432Lunney JR, Lynn J, Foley DJ, Lipson S, Guralnik JM. Patterns of functional decline at the end of life. JAMA. 2003 May 14;289(18):2387-92. doi: 10.1001/jama.289.18.2387.
PubMed 12746362Covinsky KE, Eng C, Lui LY, Sands LP, Yaffe K. The last 2 years of life: functional trajectories of frail older people. J Am Geriatr Soc. 2003 Apr;51(4):492-8. doi: 10.1046/j.1532-5415.2003.51157.x.
PubMed 12657068Partnership for Solutions. Chronic Conditions: Making the Case for Ongoing Care. Baltimore: Johns Hopkins University;2002.
Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15.
PubMed 11577478McKinley ED, Garrett JM, Evans AT, Danis M. Differences in end-of-life decision making among black and white ambulatory cancer patients. J Gen Intern Med. 1996 Nov;11(11):651-6. doi: 10.1007/BF02600155.
PubMed 9120650
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department-Based Palliative Care for Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT01358110
- Acronym / sponsor ID
- GCO 08-1234
- Conditions
- Advanced Cancer, Metastatic Cancer
- Keywords
- palliative care, cancer, emergency medicine, end- of- life care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- May 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 May 2011 (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 purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.
Detailed description
As the population ages, the number of individual living with cancer will continue to rise, and the number of Emergency Department (ED) visits for this population will continue to increase. Cancer patients visit EDs because symptoms, such as pain or vomiting, can't be controlled at home, in an assisted living facility, or in their provider's office. The ED is often the only place that can provide the necessary treatments as well as immediate access to technologically advanced testing for those with cancer. However, palliative care (PC) services, such as relief of burdensome symptoms), attention to spiritual or social concerns, and establishing goals of care, is not standard care in the ED outside of a few medical centers. Most patients do not have well-defined goals of care, and are often subjected to painful and marginally effective tests and procedures, not because they are consistent with their goals but because it is less time-consuming than discussing other options and has less perceived legal risk. Until recently little emphasis has been placed on education, research, or guidelines for the delivery of PC services in this important setting. While emergency providers could provide some of these services themselves, knowledge and skills regarding PC as well as staffing are currently inadequate to provide comprehensive services. In addition to further decreasing days spent in the hospital and health care costs, consultation by a PC team for ED cancer patients might also reduce pain and other symptoms, aid in complex medical decision-making regarding testing and treatments, and facilitate transfer to hospice or home with visiting nurse services. To enable PC consultation for ED cancer patients, the investigators will first determine who could benefit from emergent consultation, what services they need, and what characteristics of emergency providers and hospitals are preventing them from being offered. To determine what affect PC consultation for patients with advanced cancer has on symptoms, discussions with patients and families about goals of care, and how long patients spend in the ED, the investigators will then randomly assign 200 ED cancer patients to targeted PC consultation versus usual or standard care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early palliative care consultation | Experimental | Other: Early palliative care consultationEarly palliative care consultation for ED patients with advanced cancer. |
| Care as usual | Other | Other: Care as usualCare as usual, may or may not receive palliative care consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years age
- Speak English or Spanish
- ED patient with an advanced solid malignancy
Key exclusion criteria (6 listed)
- Have already been seen by palliative care team
- Cognitive deficits
- Children or adolescents
- No confirmed history of active cancer
- Do not speak English or Spanish
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 |
|---|---|---|
| Early palliative care consultationPatients will have symptoms assessed, have goals of care discussion with family and team present, and surrogate designated, as well as coordination of care and home services. | Other | Early palliative care consultation |
| Care as usualStandard care as usual which may or may not include palliative care consultation | Other | Care as usual |
Primary outcome
Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Time frame: at baseline, 6 weeks and 12 weeks
Comparison of life and quality of mental health from baseline to 6 weeks and 12 weeks.
5 secondary outcomes
Inpatient costs per day/cost of stay during hospitalization
Time frame: 6 months after hospital discharge
Hospital length of stay
Time frame: 6 months after hospital discharge
Survival
Time frame: at time of enrollment
Readmissions within 6 months of discharge
Time frame: 6 months from hospital discharge
Repeat visits to the ED in 6 months
Time frame: 6 months from hospital discharge
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 26 Jun 2015.
- Background: PubMed 10385139Wiencke JK, Zheng S, Lafuente A, Lafuente MJ, Grudzen C, Wrensch MR, Miike R, Ballesta A, Trias M. Aberrant methylation of p16INK4a in anatomic and gender-specific subtypes of sporadic colorectal cancer. Cancer Epidemiol Biomarkers Prev. 1999 Jun;8(6):501-6.
- Background: PubMed 17907029Grudzen CR, Liddicoat R, Hoffman JR, Koenig W, Lorenz KA, Asch SM. Developing quality indicators for the appropriateness of resuscitation in prehospital atraumatic cardiac arrest. Prehosp Emerg Care. 2007 Oct-Dec;11(4):434-42. doi: 10.1080/10903120701536925.
- Background: PubMed 14709435Chan GK. End-of-life models and emergency department care. Acad Emerg Med. 2004 Jan;11(1):79-86. doi: 10.1197/j.aem.2003.07.019.
- Background: PubMed 14644789McCusker J, Karp I, Cardin S, Durand P, Morin J. Determinants of emergency department visits by older adults: a systematic review. Acad Emerg Med. 2003 Dec;10(12):1362-70. doi: 10.1111/j.1553-2712.2003.tb00011.x.
- Background: PubMed 12886178Burge F, Lawson B, Johnston G. Family physician continuity of care and emergency department use in end-of-life cancer care. Med Care. 2003 Aug;41(8):992-1001. doi: 10.1097/00005650-200308000-00012.
- Background: PubMed 7474243A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-8.
- BackgroundMohanty SA SS, Bodukum VK,Grudzen CR, Lorenz K, Asch SM. Assessing the Need for Integration of Palliative Care in a Public Sector Emergency Department. Paper presented at: Academy Health2008; Washington D.C.
- Background: PubMed 18363108Mahony SO, Blank A, Simpson J, Persaud J, Huvane B, McAllen S, Davitt M, McHugh M, Hutcheson A, Karakas S, Higgins P, Selwyn P. Preliminary report of a palliative care and case management project in an emergency department for chronically ill elderly patients. J Urban Health. 2008 May;85(3):443-51. doi: 10.1007/s11524-008-9257-z.
- Background: PubMed 9541374Alpert HR, Emanuel L. Comparing utilization of life-sustaining treatments with patient and public preferences. J Gen Intern Med. 1998 Mar;13(3):175-81. doi: 10.1046/j.1525-1497.1998.00052.x.
- Background: PubMed 9305432Marco CA, Bessman ES, Schoenfeld CN, Kelen GD. Ethical issues of cardiopulmonary resuscitation: current practice among emergency physicians. Acad Emerg Med. 1997 Sep;4(9):898-904. doi: 10.1111/j.1553-2712.1997.tb03816.x.
- Background: PubMed 12746362Lunney JR, Lynn J, Foley DJ, Lipson S, Guralnik JM. Patterns of functional decline at the end of life. JAMA. 2003 May 14;289(18):2387-92. doi: 10.1001/jama.289.18.2387.
- Background: PubMed 12657068Covinsky KE, Eng C, Lui LY, Sands LP, Yaffe K. The last 2 years of life: functional trajectories of frail older people. J Am Geriatr Soc. 2003 Apr;51(4):492-8. doi: 10.1046/j.1532-5415.2003.51157.x.
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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.
Corita Grudzen, MD, MSHS principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early palliative care consultation and Care as usual in people with Advanced Cancer and Metastatic Cancer, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 6 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 26 Jun 2015. 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?
Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline (time frame: at baseline, 6 weeks and 12 weeks). 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 NCT01358110, which also lists 88 linked publications.
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 26 Jun 2015.