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CancerSCOPENCT03436290

Surgery for Cancer With Option of Palliative Care Expert

A study testing Palliative Care Intervention in people with Cancer, run by Vanderbilt University Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Palliative Care Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
1 siteUnited States
Study dates
1 Mar 2018to Nov 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • patient age is 65 years or older ii) disease is metastatic iii) disease is locally invasive requiring extensive resection
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  • Radical cystectomy
  • Pelvic exenteration
  • Abdominal debulking for ovarian or endometrial carcinoma
  • Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Palliative Care Intervention
Keywords
Palliative Care
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palliative Care InterventionBehavioural

    These patients will receive the palliative care intervention.

Study groups in NCT03436290
Study groupRoleWhat they receive
Palliative Care InterventionExperimentalNot described
Receives: Behavioral: Palliative Care Intervention
Standard of CareNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 90 days after operation

Secondary outcomes (4)

  1. 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).

    Measured: 90 days after operation

  2. 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

    Measured: 90 days after operation

  3. 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

    Measured: 180 days after operation

  4. Overall Survival

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start1 Mar 2018
  3. Primary completion24 Feb 2022
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03436290
Sponsor's protocol ID
SCOPE
Acronym
SCOPE
Status last verified
Dec 2025
First submitted
28 Dec 2017
Last updated
28 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37163249

  • 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.

    PubMed 33926535

  • 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.

    PubMed 31829237

Questions about this trial

What is this clinical trial studying?

A study testing Palliative Care Intervention in people with Cancer, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical and Functional Quality of Life as Measured by the FACT-G TOI (time frame: 90 days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03436290, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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