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NCT Number: NCT03436290

Surgery for Cancer With Option of Palliative Care Expert

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Palliative care intervention

Behavioral

These patients will receive the palliative care intervention.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  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 outcomes

  1. 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

  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 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 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study 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

Acronym: SCOPE

Important dates

Study start
2018
Primary completion
2022
Study completion
2026
First posted
Feb 19, 2018
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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