Surgery for Cancer With Option of Palliative Care Expert (SCOPE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Palliative Care Intervention

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

1. Total or partial gastrectomy requiring anastomosis
2. Total or partial pancreatectomy
3. Partial hepatectomy

4. 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

5. Radical cystectomy
6. Pelvic exenteration
7. Abdominal debulking for ovarian or endometrial carcinoma
8. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

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. Prisoner
5. 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.
6. Deaf
7. Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline

8. 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.
9. Currently participating in palliative care or seeing a palliative care provider.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Experimental: Palliative Care Intervention	Behavioral: Palliative Care Intervention; These patients will receive the palliative care intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical and Functional Quality of Life as Measured by the FACT-G TOI	FACT-Gastric Trial Outcome Index (TOI) is an efficient summary index of physical/functional outcomes and is comprised of two subscales from the FACT-Gastric Score: the physical wellbeing subscale (7 questions) and the functional wellbeing scale (7 questions). Each question uses a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Total scores on the FACT-TOI range from 0-56. The higher the score, the better the quality of life.	90 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		1 year
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
Quality of Life as Measured by the FACT-G	The FACT-G is a patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical, social, emotional, and functional well-being. Scoring: Five-point scale: 0 (not at all) to 4 (very much). Total score is from 0-108. The higher the score, the better quality of life (QOL).	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival		3 years
Physical and Functional Quality of Life	FACT-G TOI Score	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Functional Status	Karnofsky Performance Status--a score that ranges from 0 to 100, with 100 indicating full functional status and 0 indicating death	90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Quality of Life	FACT-G Score	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Depression	PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression	90 days, 180 days after operation
Anxiety	PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety	90 days, 180 days after operation
Time to Adjuvant Therapy	Number of days from operation until adjuvant chemotherapy or radiation is initiated	90 days
Post-Traumatic Growth	Post-Traumatic Growth Inventory score--a 21-item scale scored from 0-105 with higher scores indicating more growth after trauma	180 days
Care-Giver Burden	Zarit Burden Interview score--a 12 item scale with score 0-48 with higher scores indicating more care-giver burden	90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
ER Visits	Number of visits to the emergency room	3 years
Employment	Patient report of whether or not he or she is currently employed (yes/no question) and if yes, whether the employment is full-time or part-time	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Community vs. Facility Residence	Patient report of whether he or she lives in a private residence or in a healthcare facility (i.e. assisted living, long-term care facility, nursing home, etc.)	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Size of Life Space	Life Space Assessment Questionnaire score--a five item scale with scores from 0-120 with higher scores indicating larger life space i.e. larger area traversed during daily activities	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Satisfaction With Hospital Stay	The answer to the following question: Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay?	30 days
Hospital Admissions	Number of hospital admissions	3 years
Length of Hospice Enrollment		last 30 days of life
Receipt of Chemotherapy in Last 14 Days of Life		last 14 days of life
Days at Home Without an ER Visit in Last 30 Days of Life		last 30 days of life
Quality of End-of-life Care	FATE-S score	last 30 days of life
Location of Death	Care-giver report of whether patient died in a private residence or in a healthcare facility such as a nursing home, hospital, or inpatient hospice facility	last 30 days of life

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Myrick C Shinall, MD, Assistant Professor

Publications and helpful links

General Publications

• Orun OM, Shinall MC Jr, Hoskins A, Morgan E, Karlekar M, Martin SF, Ely EW, Raman R. Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer. Trials. 2021 Apr 29;22(1):314. doi: 10.1186/s13063-021-05256-y.
• Shinall MC Jr, Hoskins A, Hawkins AT, Bailey C, Brown A, Agarwal R, Duggan MC, Beskow LM, Periyakoil VS, Penson DF, Jarrett RT, Chandrasekhar R, Ely EW. A randomized trial of a specialist palliative care intervention for patients undergoing surgery for cancer: rationale and design of the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial. Trials. 2019 Dec 11;20(1):713. doi: 10.1186/s13063-019-3754-0.
• Shinall MC Jr, Martin SF, Karlekar M, Hoskins A, Morgan E, Kiehl A, Bryant P, Orun OM, Raman R, Tillman BF, Hawkins AT, Brown AJ, Bailey CE, Idrees K, Chang SS, Smith JA Jr, Tan MCB, Magge D, Penson D, Ely EW. Effects of Specialist Palliative Care for Patients Undergoing Major Abdominal Surgery for Cancer: A Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):747-755. doi: 10.1001/jamasurg.2023.1396.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): February 24, 2022
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Palliative Care
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SCOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No