Surgery for Cancer With Option of Palliative Care Expert

Not Applicable

Active, not recruiting

• Conditions: Cancer
• Interventions: Behavioral: Palliative Care Intervention

• Registration Number: NCT03436290
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-28
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-19
• Study Start: 2018-03-01
• Primary Completion: 2022-02-24
• Results First Submitted: 2023-02-23
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Results First Posted: 2024-06-10
• Last Update Posted: 2024-06-10
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 236

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palliative Care Intervention	Palliative Care Intervention	-

Primary Outcome Measures

Name	Time	Method
Physical and Functional Quality of Life as Measured by the FACT-G TOI	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 Outcome Measures

Name	Time	Method
Quality of Life as Measured by the FACT-G	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).
Days Alive at Home Without an Emergency Room Visit	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
Post-Traumatic Stress Disorder (PTSD) Symptoms	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
Overall Survival	1 year

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States