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Surgery with Palliative Care for Cancer (SCOPE Trial)
N/A
Waitlist Available
Led By Myrick C Shinall, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients (≥18 years old) scheduled for specific 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 patient age is 65 years or older or disease is metastatic or disease is locally invasive requiring extensive resection, Radical cystectomy, Pelvic exenteration, Abdominal debulking for ovarian or endometrial carcinoma, Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
SCOPE Trial Summary
This trial is testing whether adding a team of specialists that focus on lessening a cancer patient's symptoms to their regular care improves the overall care experience.
Who is the study for?
This trial is for cancer patients aged 18 or older, scheduled for specific major abdominal surgeries aimed at controlling malignancy. It's especially for those with metastatic or locally invasive disease requiring extensive resection. Patients must be able to give consent and live within a reasonable distance from the hospital. Those already in palliative care, non-English speakers, or with severe cognitive issues can't join.Check my eligibility
What is being tested?
The study compares usual surgery and cancer care versus adding comprehensive palliative care services before surgery. Palliative care aims to manage pain and other symptoms like breathlessness and anxiety, hoping to improve patient and family experience when introduced early.See study design
What are the potential side effects?
Since this trial involves non-pharmacological intervention (palliative care), there are no direct side effects like you'd expect from medication. However, it may bring emotional responses as patients cope with serious illness through supportive measures.
SCOPE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult scheduled for a major abdominal cancer surgery.
SCOPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Physical and Functional Quality of Life as measured by the FACT-G TOI
Secondary outcome measures
Days Alive at Home without an Emergency Room Visit
Overall survival
Post-Traumatic Stress Disorder (PTSD) Symptoms
+1 moreOther outcome measures
Anxiety
Care-Giver Burden
Community vs. Facility Residence
+17 moreSCOPE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Palliative Care InterventionExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palliative Care Intervention
2018
Completed Phase 2
~600
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
671,921 Total Patients Enrolled
Myrick C Shinall, MDPrincipal InvestigatorAssistant Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a severe brain condition that stops me from living on my own.I am an adult scheduled for a major abdominal cancer surgery.I do not speak English.I can't do follow-ups because I don't have a phone or can't use one.I am not currently in a study that restricts joining another or involves non-drug surgery or cancer care.I am deaf.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Palliative Care Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to become involved in this research initiative as a participant?
"According to clinicaltrials.gov, this medical study, posted on March 1st 2018 and last updated April 18th 2022, is not presently enrolling patients. However, there are currently 486 other studies actively searching for participants."
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