This trial studies early palliative care in improving recovery and quality of life in patients with cancer undergoing abdominal surgery. Frequently people diagnosed with cancer experience physical and emotional symptoms during the course of their disease. Introduction to a team of clinicians that specialize in the lessening of many of these distressing symptoms may improve overall care. This team of clinicians is called the palliative care team and they focus on ways to improve pain and other symptom management (i.e. shortness of breath, fatigue, anxiety, etc.) and to assist patients and their families in coping with the emotional, social, and spiritual issues associated with a cancer diagnosis. This study is being done to see if receiving palliative care earlier is more useful compared to receiving palliative care late in the course of illness.
Additional locations may be listed on ClinicalTrials.gov for NCT03436290.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine whether a palliative care intervention improves recovery and quality of life after major abdominal operations for cancer.
SECONDARY OBJECTIVES:
I. To determine whether the palliative care intervention improves long-term functioning and quality of life for these patients.
II. To determine whether the palliative care intervention improves end of life (EOL) care for the subset of patients who die during the study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo usual surgery and receive usual cancer care.
ARM II: Patients undergo usual surgery and receive usual cancer care. Patients also receive comprehensive palliative care before surgery for 1 hour, twice after surgery on the hospital inpatient unit for 30 minutes, after hospital discharge at least every 3 months, and every time the patient is admitted to the hospital at Vanderbilt for 3 years.
After completion of study, all patients are followed up at 30, 60, 90, and 180 days after operation, and then every 6 months for 3 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorRicky Shinall
