Surgery for Cancer With Option of Palliative Care Expert

Cancer Clinical Trial

— SCOPE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03436290
• Other study ID #: SCOPE
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: November 2024

Study information

• Verified date: April 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: November 2024
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Palliative Care Intervention
These patients will receive the palliative care intervention.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical and Functional Quality of Life	FACT-G TOI Score	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other	Functional Status	Karnofsky Performance Status--a score that ranges from 0 to 100, with 100 indicating full functional status and 0 indicating death	90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other	Quality of Life	FACT-G Score	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other	Depression	PROMIS Depression-6 Score--A six item scale with scores from 5-30 with higher scores indicating more symptoms of depression	90 days, 180 days after operation
Other	Anxiety	PROMIS Anxiety-6 Score--A six item scale with scores from 5-30 with higher scores indicating more anxiety	90 days, 180 days after operation
Other	Time to Adjuvant Therapy	Number of days from operation until adjuvant chemotherapy or radiation is initiated	90 days
Other	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?	30 days
Other	Post-Traumatic Growth	Post-Traumatic Growth Inventory score--a 21-item scale scored from 0-105 with higher scores indicating more growth after trauma	180 days
Other	Care-Giver Burden	Zarit Burden Interview score--a 12 item scale with score 0-48 with higher scores indicating more care-giver burden	90 days, 180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other	Hospital admissions	Number of hospital admissions	3 years
Other	ER Visits	Number of visits to the emergency room	3 years
Other	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	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other	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.)	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other	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	180 days, 12 months, 18 months, 24 months, 30 months, 36 months after operation
Other	Length of hospice enrollment		last 30 days of life
Other	Receipt of chemotherapy in last 14 days of life		last 14 days of life
Other	Days at home without an ER visit in last 30 days of life		last 30 days of life
Other	Quality of end-of-life care	FATE-S score	last 30 days of life
Other	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	last 30 days of life
Other	Survival		3 years
Primary	Physical and Functional Quality of Life as measured by the FACT-G TOI	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.	90 days after operation
Secondary	Quality of Life as measured by the FACT-G	Total score of all four subscales of the FACT-G instrument as described above	90 days after operation
Secondary	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	90 days after operation
Secondary	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	180 days after operation
Secondary	Overall survival		1 year