Clinical trial NCT03436290: Surgery for Cancer With Option of Palliative Care Expert
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Palliative Care
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical and Functional Quality of Life as Measured by the FACT-G TOI
timeFrame: 90 days after operation
Secondary outcomes:
measure: Quality of Life as Measured by the FACT-G
timeFrame: 90 days after operation
measure: Days Alive at Home Without an Emergency Room Visit
timeFrame: 90 days after operation
measure: Post-Traumatic Stress Disorder (PTSD) Symptoms
timeFrame: 180 days after operation
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
measure: Physical and Functional Quality of Life
timeFrame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
measure: Functional Status
timeFrame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
measure: Quality of Life
timeFrame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
measure: Depression
timeFrame: 90 days, 180 days after operation
measure: Anxiety
timeFrame: 90 days, 180 days after operation
measure: Time to Adjuvant Therapy
timeFrame: 90 days
measure: Satisfaction With Hospital Stay
timeFrame: 30 days
measure: Post-Traumatic Growth
timeFrame: 180 days
measure: Care-Giver Burden
timeFrame: 90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
measure: Hospital Admissions
timeFrame: 3 years
measure: ER Visits
timeFrame: 3 years
measure: Employment
timeFrame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
measure: Community vs. Facility Residence
timeFrame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
measure: Size of Life Space
timeFrame: 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
measure: Length of Hospice Enrollment
timeFrame: last 30 days of life
measure: Receipt of Chemotherapy in Last 14 Days of Life
timeFrame: last 14 days of life
measure: Days at Home Without an ER Visit in Last 30 Days of Life
timeFrame: last 30 days of life
measure: Quality of End-of-life Care
timeFrame: last 30 days of life
measure: Location of Death
timeFrame: last 30 days of life
measure: Survival
timeFrame: 3 years
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Assistant Professor
name: Myrick C Shinall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.