Surgery for Cancer With Option of Palliative Care Expert
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2018 |
| Start Date: | March 1, 2018 |
| End Date: | January 2023 |
Surgery for Cancer With Option of Palliative Care Expert: A Randomized Trial of an Early Palliative Care Intervention for Patients Undergoing Surgery for Cancer
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 (i.e. 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.
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 (i.e. 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.
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.
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.
Inclusion Criteria:
- [1] adult patients (≥18 years old)
- [2] scheduled for an elective resection of selected abdominal malignancies not limited
to but including the following: pancreatic resection, liver resection, colectomy,
proctectomy, pelvic exenteration, cytoreductive surgery, hyperthermic intraperitoneal
chemotherapy, abdominal debulking, and radical cystectomy.
Exclusion Criteria:
- [1]Non-English speaking patient
- [2]Residence >150 miles away from Vanderbilt and do not visit the Nashville area
regularly
- [3]No telephone or otherwise unwilling/unable to complete follow-ups
- [4]Inability to obtain informed consent from patient meeting all inclusion criteria
for the following reasons:
1. Attending surgeon refusal
2. Patient refusal
3. Period of time between screening patient and time of operation does not allow
preoperative outpatient palliative care visit.
- [5]Prisoner
- [6]Current enrollment in a study that does not allow co-enrollment or that uses a
non-pharmacologic, non-procedural intervention directed at surgical or cancer care.
- [7] Severe prior cognitive or neurodegenerative disorder that prevents a patient from
living independently at baseline
- [8] Already receiving specialist palliative care at time of study enrollment
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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