Surgery with Palliative Care for Cancer

(SCOPE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Non-English, Distance, Cognitive disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

236 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Palliative Care Intervention in the clinical trial Surgery with Palliative Care for Cancer?

Research suggests that palliative care interventions can improve outcomes that matter to patients, such as symptom management and communication, in surgical patients with advanced illness. Although specific data on this exact treatment in the context of surgery is limited, similar approaches have shown benefits in managing symptoms and enhancing quality of life for patients with serious illnesses. ^{1 2 3 4 5}

Is surgery with palliative care generally safe for cancer patients?

Palliative care interventions in surgical patients with cancer are associated with improved quality of care and patient-centered outcomes, without compromising survival. However, they can carry risks, so careful patient selection and open communication about potential benefits and risks are important to minimize complications. ^{2 6 7 8 9}

How does surgery with palliative care for cancer differ from other treatments?

This treatment is unique because it combines surgery with palliative care, focusing on improving quality of life and managing symptoms rather than curing the cancer. It involves a multi-disciplinary team to ensure holistic care and careful patient selection to balance benefits and risks. ^{2 3 9 10 11}

Research Team

Myrick C Shinall, MD

Principal Investigator

Assistant Professor

Eligibility Criteria

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.

Inclusion Criteria

I am an adult scheduled for a major abdominal cancer surgery.

Exclusion Criteria

I do not have a severe brain condition that stops me from living on my own.

Inability to obtain informed consent from patient meeting all inclusion criteria for specific reasons: Attending surgeon refusal, Patient refusal, Period of time between screening patient and time of operation does not allow preoperative outpatient palliative care visit, Currently participating in palliative care or seeing a palliative care provider.

I do not speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Palliative Care

Participants in the intervention arm receive a preoperative outpatient specialty palliative care consultation

1-2 weeks

Perioperative Care

Participants undergo surgery for selected gastrointestinal and genitourinary malignancies

1 week

Postoperative Palliative Care

Intervention arm patients receive inpatient and outpatient palliative care follow-up postoperatively

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• Palliative Care Intervention

Trial Overview 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.

Participant Groups

Group I: Palliative Care Intervention Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

In a study of 152 surgical oncology patients, those receiving hospital-based early palliative care showed better outcomes in pain management and symptom distress over 12 months compared to standard care, although these differences were not statistically significant.

Patients in the palliative care group reported improved communication, emotional support, and pain management, highlighting the potential benefits of integrated palliative care services in enhancing patient experience and resources for pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care outcomes in surgical oncology patients with advanced malignancies: a mixed methods approach. Wallen, GR., Baker, K., Stolar, M., et al.[2021]

References

1. China pubmed.ncbi.nlm.nih.gov

Patients' perceptions of palliative surgical procedures: a qualitative analysis. [2018]

2. China pubmed.ncbi.nlm.nih.gov

Palliative care interventions for surgical patients: a narrative review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Nomenclature in Palliative Surgery. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Indicators of symptom improvement and survival in inpatients with advanced cancer undergoing palliative surgical consultation. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Palliative care outcomes in surgical oncology patients with advanced malignancies: a mixed methods approach. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evidence for integration of palliative care into surgical oncology practice and education. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Strategies to Improve Perioperative Palliative Care Integration for Seriously Ill Veterans. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Selecting Patients for Palliative Procedures in Oncology. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Indicators of surgery and survival in oncology inpatients requiring surgical evaluation for palliation. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Multi-Disciplinary Team and Quality of Goals of Care Discussions in Palliative Surgical Oncology Patients. [2023]