Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03436290
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2017-12-28
Brief Title:
Surgery for Cancer With Option of Palliative Care Expert
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Surgery for Cancer With Option of Palliative Care Expert A Randomized Trial of an Early Palliative Care Intervention for Patients Undergoing Surgery for Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCOPE
Brief Summary:
Frequently people diagnosed with cancer experience physical and emotional symptoms during the course of their disease These symptoms can be very distressing to both the patient and the family members The study doctor wants to know if the introduction of a team of clinicians that specialize in the lessening of many of these distressing symptoms may improve your overall care This team of clinicians is called the palliative care team and they focus on ways to improve your pain and other symptom management ie shortness of breath fatigue anxiety etc and to assist you and your family in coping with the emotional social and spiritual issues associated with your diagnosis The team consists of physicians advanced practice nurses case managers and nurses who have been specially trained in the care of patients facing serious illness
This research study is being done because although many people with cancer receive palliative care late in the course of their illness the study team thinks palliative care may be more useful when it is started earlier and in this case before surgery The main purpose of this study is to compare two types of care -usual surgery and cancer care and usual surgery and cancer care with comprehensive palliative care services to see which is better for improving the experience of patients and families with cancer
This research study is being done because although many people with cancer receive palliative care late in the course of their illness the study team thinks palliative care may be more useful when it is started earlier and in this case before surgery The main purpose of this study is to compare two types of care -usual surgery and cancer care and usual surgery and cancer care with comprehensive palliative care services to see which is better for improving the experience of patients and families with cancer
Detailed Description:
The Surgery for Cancer with Option of Palliative Care Expert SCOPE Trial is an investigation that will study the effect of a palliative care implementation during the preoperative perioperative and postoperative phase for adults undergoing cancer surgery for selected gastrointestinal and genitourinary malignancies SCOPE will be a single-blind single-institution randomized controlled trial of 236 patients Intervention arm patients will receive a preoperative outpatient specialty palliative care consultation from a palliative care provider physician or nurse practitioner in addition to inpatient and outpatient palliative care follow-up postoperatively Control arm patients will receive usual care with palliative care available at the discretion of the primary treatment team currently these patients rarely get palliative care and usually only in the last weeks of life The central hypothesis of the SCOPE Trial is that preoperative perioperative and postoperative specialty palliative care will improve patient functioning and quality of life in patients undergoing resection of selected GI and GU malignancies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None