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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if introducing palliative care—a team approach to ease symptoms and support emotional and social needs—before cancer surgery can improve care for patients and their families. Participants will be divided into two groups: one will receive standard cancer surgery and care, while the other will receive the same surgery plus additional palliative care services. This study targets adults scheduled for specific major abdominal surgeries, such as a gastrectomy or pancreatectomy, with the goal of treating cancer. As an unphased trial, it offers participants the chance to contribute to innovative care approaches that could enhance patient and family experiences during cancer treatment.

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 prior data suggests that this palliative care intervention is safe for cancer patients?

Research has shown that palliative care can be safely combined with regular cancer treatment. Studies have found that palliative care improves the quality of life and emotional well-being of cancer patients. Those who receive these services often experience better emotional and physical health. No major negative effects are linked to palliative care, making it manageable for patients.

Palliative care focuses on relieving symptoms like pain, tiredness, and anxiety, helping patients cope with the emotional and social challenges of their illness. The care team typically includes doctors and nurses specially trained in this type of care. This approach supports patients and their families throughout their cancer journey.

Overall, palliative care is considered safe and helpful. It does not replace regular treatment but works alongside it to enhance the overall experience for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach to cancer treatment, which often focuses solely on surgery or chemotherapy, the palliative care intervention being studied aims to improve quality of life from the outset. This approach integrates palliative care alongside traditional treatments, emphasizing symptom management and emotional support right from the start. Researchers are excited because this could lead to a more holistic treatment model that not only targets the cancer but also enhances overall well-being and potentially improves outcomes by addressing patients' comprehensive needs.

What evidence suggests that palliative care intervention might be an effective treatment for cancer?

Research shows that starting palliative care early can greatly improve the quality of life for cancer patients. In this trial, participants in the Palliative Care Intervention arm will receive early palliative care, which studies have shown improves physical health, including reducing pain. Another study found that early palliative care helped reduce stress and depression in caregivers. Additionally, nurse-led palliative care helped patients manage daily activities better. Overall, evidence supports that beginning palliative care sooner can help manage both physical and emotional symptoms for cancer patients and their families. ^{3 6 7 8 9}

Who Is on the Research Team?

Myrick C Shinall, MD

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

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

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 have a severe brain condition that stops me from living on my own.

I can't do follow-ups because I don't have a phone or can't use one.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7481603/

Earlier multidisciplinary palliative care intervention for people ... Early palliative care for people with lung cancer was effective in improving caregivers' total distress and depression, but not anxiety or overall quality of ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830599

Algorithm-Based Palliative Care in Patients With Cancer Rates of systemic therapy within 14 days of death were 6.5% (6 of 92 patients) in the intervention group and 16.1% (14 of 87 patients) in the ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.24.00542

Palliative Care for Patients With Cancer: ASCO Guideline ... The primary outcome for 15 trials for Research Question 1 was QOL,8-21 and eight studies identified QOL as the secondary outcomes.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020748925001117

The effect of nurse-led enhanced supportive care as an ... Nurse-led enhanced supportive care as an early primary palliative care approach has demonstrated effectiveness in improving the role functioning domain of ...

5. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-025-02831-z

The effect of community-based palliative supportive care ... According to findings, community-based palliative support could improve the physical status of cancer patients, including pain relief and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11395880/

The Paradox of Palliative Care at the End of Life: Higher Rates ... Less than 30% of patients with pancreatic cancer received a PCC. Those who received a PCC had more aggressive interventions in the end-of-life period.

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/184422

Effects of a Palliative Care Intervention on Clinical ... Median survival was 14 months (95% CI, 10.6-18.4 months) for the intervention group and 8.5 months (95% CI, 7.0-11.1 months) for the usual care ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748924002001

Effectiveness of palliative care interventions on patient ... Palliative care interventions have improved patient-reported quality of life, psychological health, and spiritual well-being in community-dwelling patients ...

9. bmj.com bmj.com/content/370/bmj.m2257

Association between palliative care and healthcare ... Palliative care was also associated with a 1.67 increased odds of death at home. We compared these associations between different trajectories ...