Surgery for Cancer With Option of Palliative Care Expert

NCT ID: NCT03436290

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2026-11-30

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 (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

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Palliative Care Intervention

Group Type: EXPERIMENTAL

Palliative Care Intervention

Intervention Type: BEHAVIORAL

These patients will receive the palliative care intervention.

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Palliative Care Intervention

These patients will receive the palliative care intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Myrick C. Shinall, Jr., MD, PhD

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myrick C Shinall, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37163249 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33926535 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31829237 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SCOPE

Identifier Type: -

Identifier Source: org_study_id