An interventional study of Palliative Care Intervention in Cancer, sponsored by Vanderbilt University Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
adult patients (≥18 years old) scheduled for one of the following abdominal operations with intent to provide cure or durable oncologic control of malignancy:
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
Exclusion Criteria:
Inability to obtain informed consent from patient meeting all inclusion criteria for the following reasons:
Behavioral: Palliative Care Intervention
These patients will receive the palliative care intervention.
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.
Time frame: 90 days after operation
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).
Time frame: 90 days after operation
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
Time frame: 90 days after operation
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
Time frame: 180 days after operation
Overall Survival
Time frame: 1 year
Physical and Functional Quality of Life
FACT-G TOI Score
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Functional Status
Karnofsky Performance Status--a score that ranges from 0 to 100, with 100 indicating full functional status and 0 indicating death
Time frame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Quality of Life
FACT-G Score
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Depression
PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression
Time frame: 90 days, 180 days after operation
Anxiety
PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety
Time frame: 90 days, 180 days after operation
Time to Adjuvant Therapy
Number of days from operation until adjuvant chemotherapy or radiation is initiated
Time frame: 90 days
Satisfaction With Hospital Stay
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?
Time frame: 30 days
Post-Traumatic Growth
Post-Traumatic Growth Inventory score--a 21-item scale scored from 0-105 with higher scores indicating more growth after trauma
Time frame: 180 days
Care-Giver Burden
Zarit Burden Interview score--a 12 item scale with score 0-48 with higher scores indicating more care-giver burden
Time frame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Hospital Admissions
Number of hospital admissions
Time frame: 3 years
ER Visits
Number of visits to the emergency room
Time frame: 3 years
Employment
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
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Community vs. Facility Residence
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.)
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Size of Life Space
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
Time frame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Length of Hospice Enrollment
Time frame: last 30 days of life
Receipt of Chemotherapy in Last 14 Days of Life
Time frame: 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
Quality of End-of-life Care
FATE-S score
Time frame: last 30 days of life
Location of Death
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
Time frame: last 30 days of life
Survival
Time frame: 3 years
| Milestone | Palliative Care Intervention | Standard of Care |
|---|---|---|
| Started | 118 | 118 |
| Completed | 77 | 118 |
| Not completed | 41 | 0 |
| Withdrew: Post-randomization exclusion | 1 | 0 |
| Withdrew: Death | 6 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 |
| Withdrew: Protocol violation | 30 | 0 |
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.
| units on a scale | Palliative Care Intervention | Standard of Care |
|---|---|---|
| Physical and Functional Quality of Life as Measured by the FACT-G TOI | 45.0 (36.2 to 50.0) | 45.0 (39.0 to 50.0) |
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).
| units on a scale | Palliative Care Intervention | Standard of Care |
|---|---|---|
| Quality of Life as Measured by the FACT-G | 88.0 (72.8 to 99.0) | 91.0 (79.5 to 98.3) |
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
| days | Palliative Care Intervention | Standard of Care |
|---|---|---|
| Days Alive at Home Without an Emergency Room Visit | 84 (76 to 86) | 83 (79 to 85) |
Score on the PTSD Checklist-Civilian Version--a 17-item scale scored from 17-85 with higher scores indicating more PTSD symptoms
Results for this outcome have not been posted.
| proportion of patients surviving 1 year | Palliative Care Intervention | Standard of Care |
|---|---|---|
| Overall Survival | 0.83 (0.76 to 0.90) | 0.82 (0.75 to 0.90) |
FACT-G TOI Score
Results for this outcome have not been posted.
Karnofsky Performance Status--a score that ranges from 0 to 100, with 100 indicating full functional status and 0 indicating death
Results for this outcome have not been posted.
FACT-G Score
Results for this outcome have not been posted.
PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression
Results for this outcome have not been posted.
PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety
Results for this outcome have not been posted.
Number of days from operation until adjuvant chemotherapy or radiation is initiated
Results for this outcome have not been posted.
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?
Results for this outcome have not been posted.
Post-Traumatic Growth Inventory score--a 21-item scale scored from 0-105 with higher scores indicating more growth after trauma
Results for this outcome have not been posted.
Zarit Burden Interview score--a 12 item scale with score 0-48 with higher scores indicating more care-giver burden
Results for this outcome have not been posted.
Number of hospital admissions
Results for this outcome have not been posted.
Number of visits to the emergency room
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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.)
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
FATE-S score
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Palliative Care Intervention | 6/117 (5.1%) | 0/117 (0%) | 0/117 (0%) |
| Standard of Care | 4/118 (3.4%) | 0/118 (0%) | 0/118 (0%) |
Excludes one patient who was excluded after randomization
| Age, Continuous(years) | Palliative Care Intervention | Standard of Care | Total |
|---|---|---|---|
| Median | 62.3 (56.6 to 69.3) | 66.6 (57.8 to 71.6) | 65 (56.8 to 71.1) |
| Sex: Female, Male(Participants) | Palliative Care Intervention | Standard of Care | Total |
|---|---|---|---|
| Female | 46 | 48 | 94 |
| Male | 71 | 70 | 141 |
| Ethnicity (NIH/OMB)(Participants) | Palliative Care Intervention | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 117 | 116 | 233 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Palliative Care Intervention | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 4 | 9 |
| White | 111 | 113 | 224 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Palliative Care Intervention | Standard of Care | Total |
|---|---|---|---|
| United States | 117 | 118 | 235 |
| FACT-TOI(units on a scale) | Palliative Care Intervention | Standard of Care | Total |
|---|---|---|---|
| Median | 43.0 (34.8 to 50.0) | 44.0 (38.0 to 51.0) | 43.0 (36.0 to 50.0) |
| FACT-G(units on a scale) | Palliative Care Intervention | Standard of Care | Total |
|---|---|---|---|
| Median | 85.0 (72.9 to 94.0) | 87.4 (76.0 to 95.0) | 86.0 (74.8 to 94.6) |
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Vanderbilt University Medical Center