Surgery for Cancer With Option of Palliative Care Expert

NCT03436290 | Active Not Recruiting Results

• 1 other identifier: SCOPE
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of Life as Measured by the FACT-G

  90 days after operation

• Days Alive at Home Without an Emergency Room Visit

  90 days after operation

• Post-Traumatic Stress Disorder (PTSD) Symptoms

  180 days after operation

• Overall Survival

  1 year

Other Outcomes (20)

• Physical and Functional Quality of Life

  180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

• Functional Status

  90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

• Quality of Life

  180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation

Study Arms (2)

Palliative Care Intervention

EXPERIMENTAL

Behavioral: Palliative Care Intervention

Standard of Care

NO INTERVENTION

Interventions

Palliative Care Intervention BEHAVIORAL

These patients will receive the palliative care intervention.

Palliative Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (3)

• 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.

  PMID: 37163249 DERIVED

• 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.

  PMID: 33926535 DERIVED

• 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.

  PMID: 31829237 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Myrick Shinall, principal investigator
• Organization: Vanderbilt University Medical Center

ricky.shinall@vumc.org

615-343-5613

Study Officials

• Myrick C Shinall, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: February 24, 2022
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 28, 2026
• Results First Posted: June 10, 2024

Record last verified: 2025-12

Locations

US (1)