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

• ClinicalTrials.gov Identifier: NCT03436290
• Recruitment Status: Enrolling by invitation
• First Posted: February 16, 2018
• Last Update Posted: December 20, 2018
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Myrick C. Shinall, Jr., MD, PhD, Vanderbilt University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Behavioral: Palliative Care Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 1, 2018
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Functional status as measured by the FACT-G TOI [ Time Frame: 90 days after operation ]
   The FACT-G has 27 questions using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored. Questions measure the respondents' health state over the last 7 days in four subscales: Physical Well-Being (PWB, 7 questions), Social/Family Well-Being (SWB, 7 questions), Emotional Well-Being (EWB, 6 questions), and Functional Well-being (FWB, 7 questions). The Trial Outcome Index (TOI) is the sum of the Physical Well-Being and Functional Well-Being subscales. The TOI is an efficient summary index of physical/functional outcomes and is a common endpoint used in clinical trials.

Secondary Outcome Measures :

1. Quality of Life as measured by the FACT-G [ Time Frame: 90 days after operation ]
   Total score of all four subscales of the FACT-G instrument as described above
2. 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
3. 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
4. Overall survival [ Time Frame: 1 year ]

Other Outcome Measures:

1. Functional Status [ Time Frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation ]
   FACT-G TOI Score
2. 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
3. Quality of Life [ Time Frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation ]
   FACT-G Score
4. Depression [ Time Frame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation ]
   PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression
5. Anxiety [ Time Frame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation ]
   PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety
6. Time to Adjuvant Therapy [ Time Frame: 90 days ]
   Number of days from operation until adjuvant chemotherapy or radiation is initiated
7. 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?
8. 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
9. 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
10. Hospital admissions [ Time Frame: 3 years ]
    Number of hospital admissions
11. ER Visits [ Time Frame: 3 years ]
    Number of visits to the emergency room
12. 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
13. 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.)
14. 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
15. Length of hospice enrollment [ Time Frame: last 30 days of life ]
16. Receipt of chemotherapy in last 14 days of life [ Time Frame: last 14 days of life ]
17. Days at home without an ER visit in last 30 days of life [ Time Frame: last 30 days of life ]
18. Quality of end-of-life care [ Time Frame: last 30 days of life ]
    FATE-S score
19. 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
20. Survival [ Time Frame: 3 years ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• [1] adult patients (≥18 years old)
• [2] scheduled for an elective resection of selected abdominal malignancies not limited to but including the following: pancreatic resection, liver resection, colectomy, proctectomy, pelvic exenteration, cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, abdominal debulking, and radical cystectomy.

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]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.
• [5]Prisoner
• [6]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.
• [7] Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline
• [8] Already receiving specialist palliative care at time of study enrollment

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Myrick C Shinall, MD; Assistant Professor

More Information

• Responsible Party: Myrick C. Shinall, Jr., MD, PhD, Assistant Professor of Surgery, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03436290 History of Changes
• Other Study ID Numbers: SCOPE
• First Posted: February 16, 2018
• Last Update Posted: December 20, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Myrick C. Shinall, Jr., MD, PhD, Vanderbilt University Medical Center:

Palliative Care