Surgery for Cancer With Option of Palliative Care Expert

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Surgery for Cancer With Option of Palliative Care Expert: A Randomized Trial of an Early Palliative Care Intervention for Patients Undergoing Surgery for Cancer

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Palliative Care Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (≥18 years old) scheduled for one of the following abdominal operations with intent to provide cure or durable oncologic control of malignancy: Total or partial gastrectomy requiring anastomosis Total or partial pancreatectomy Partial hepatectomy Colectomy or proctactomy if one of the following 3 conditions is also met: i) patient age is 65 years or older ii) disease is metastatic iii) disease is locally invasive requiring extensive resection Radical cystectomy Pelvic exenteration Abdominal debulking for ovarian or endometrial carcinoma Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy Exclusion Criteria: Non-English speaking patient Residence >150 miles away from Vanderbilt and do not visit the Nashville area regularly No telephone or otherwise unwilling/unable to complete follow-ups Prisoner 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. Deaf Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline Inability to obtain informed consent from patient meeting all inclusion criteria for the following reasons: Attending surgeon refusal Patient refusal Period of time between screening patient and time of operation does not allow preoperative outpatient palliative care visit. Currently participating in palliative care or seeing a palliative care provider.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palliative Care Intervention<br> | Behavioral: Palliative Care Intervention<br>* These patients will receive the palliative care intervention.<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical and Functional Quality of Life as measured by the FACT-G TOI | The FACT-G has 27 questions using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored. Questions measure the respondents' health state over the last 7 days in four subscales: Physical Well-Being (PWB, 7 questions), Social/Family Well-Being (SWB, 7 questions), Emotional Well-Being (EWB, 6 questions), and Functional Well-being (FWB, 7 questions). The Trial Outcome Index (TOI) is the sum of the Physical Well-Being and Functional Well-Being subscales. The TOI is an efficient summary index of physical/functional outcomes and is a common endpoint used in clinical trials. | 90 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as measured by the FACT-G | Total score of all four subscales of the FACT-G instrument as described above | 90 days after operation | 
| Days Alive at Home without an Emergency Room Visit | A count of all the days that the patient 1) has no emergency room visits, and 2) is not an inpatient of a hospital or other health-care facility | 90 days after operation | 
| Post-Traumatic Stress Disorder (PTSD) Symptoms | Score on the PTSD Checklist-Civilian Version--a 17-item scale scored from 17-85 with higher scores indicating more PTSD symptoms | 180 days after operation | 
| Overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care