Clinical trial · Interventional
Surgery for Cancer With Option of Palliative Care Expert
Surgery for Cancer With Option of Palliative Care Expert: A Randomized Trial of an Early Palliative Care Intervention for Patients Undergoing Surgery for Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative Care Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Palliative Care Intervention
- interventionNames
- Behavioral: Palliative Care Intervention
- type
- NO_INTERVENTION
- label
- Standard of Care
Primary outcomes (1)
- measure
- Physical and Functional Quality of Life as Measured by the FACT-G TOI
- timeFrame
- 90 days after operation
- description
- 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 outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDShinall MC Jr, Martin SF, Karlekar M, Hoskins A, Morgan E, Kiehl A, Bryant P, Orun OM, Raman R, Tillman BF, Hawkins AT, Brown AJ, Bailey CE, Idrees K, Chang SS, Smith JA Jr, Tan MCB, Magge D, Penson D, Ely EW. Effects of Specialist Palliative Care for Patients Undergoing Major Abdominal Surgery for Cancer: A Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):747-755. doi: 10.1001/jamasurg.2023.1396. PMID 37163249
- DERIVEDOrun 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. PMID 33926535
- DERIVEDShinall 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. PMID 31829237