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

January 11, 2026 updated by: Myrick C. Shinall, Jr., MD, PhD, Vanderbilt University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical and Functional Quality of Life as Measured by the FACT-G TOI
Time Frame: 90 days after operation
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 1 year
1 year
Post-Traumatic Stress Disorder (PTSD) Symptoms
Time Frame: 180 days after operation
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
Time Frame: 90 days after operation
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
Time Frame: 90 days after operation
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 3 years
3 years
Physical and Functional Quality of Life
Time Frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
FACT-G TOI Score
180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Functional Status
Time Frame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
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
Time Frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
FACT-G Score
180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Depression
Time Frame: 90 days, 180 days after operation
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
Time Frame: 90 days, 180 days after operation
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
Time Frame: 90 days
Number of days from operation until adjuvant chemotherapy or radiation is initiated
90 days
Post-Traumatic Growth
Time Frame: 180 days
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
Time Frame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
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
Time Frame: 3 years
Number of visits to the emergency room
3 years
Employment
Time Frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
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
Time Frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
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
Time Frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
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
Time Frame: 30 days
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
Time Frame: 3 years
Number of hospital admissions
3 years
Length of Hospice Enrollment
Time Frame: last 30 days of life
last 30 days of life
Receipt of Chemotherapy in Last 14 Days of Life
Time Frame: last 14 days of life
last 14 days of life
Days at Home Without an ER Visit in Last 30 Days of Life
Time Frame: last 30 days of life
last 30 days of life
Quality of End-of-life Care
Time Frame: last 30 days of life
FATE-S score
last 30 days of life
Location of Death
Time Frame: last 30 days of life
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Myrick C Shinall, MD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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