The study goal is to compare surgeon-palliative care team co-management, versus surgeon alone management, of patients and family members preparing for major upper gastrointestinal cancer surgery. The study also aims to explore, using qualitative methods, the impact of surgeon-palliative care team co-management versus surgeon alone management on the perioperative care experience for patients, family members, surgeons, and palliative care clinicians.
The components of surgeon palliative care team co management practices will include Time, Education, Assessments, and Multi disciplinary (TEAM) element. 1. Time; At least 60 minutes/month (per patient and caregiver preference) devoted to palliative care treatments for the patient and family 2. Education - Patients and family members, per their desires and wishes, are counseled and educated about their disease, including self-management of symptoms, prognosis, and treatment options 3. Assessment - Formal assessment of symptoms including pain, dyspnea, constipation/diarrhea, anxiety/depression, fatigue, and nausea. Edmonton symptom score33 will be used as a formal assessment. 4. Multi-Disciplinary - Management must be multi disciplinary with access to a multi-disciplinary palliative care team composed of nurse, physician, social worker, pharmacist, and/or chaplain team members.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
379
Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
The surgeon and surgical team will manage
Stanford University
Stanford, California, United States
Johns Hopkins Hostpital
Baltimore, Maryland, United States
Dana Farber/ Brigham
Boston, Massachusetts, United States
University of New Mexico
Albuquerque, New Mexico, United States
Patient Quality of Life Patient Quality of Life 12 Weeks After Surgery
Patient quality of life will be measured by the Functional Assessment of Chronic Illness Therapy Palliative care subscale (FACIT-PAL). FACIT-PAL is a compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. FACIT-PAL has 46 item self report measure. The range is from 0-184 for the FACIT-PAL. A higher score is a better outcome.
Time frame: Up to 12 weeks after surgery
Patient Mood Symptoms Assessment 12 Weeks After Surgery
Patient symptoms were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) version 2.1. PROMIS-29 survey questions were each rated on a 5-point Likert scale (range: 1 to 5, higher scores represent a better outcome). Item responses were converted to PROMIS T-scores per the PROMIS scoring manual (population mean = 50, SD = 10). T-scores were then converted to standardized z-scores using the formula (T-score - 50) / 10. Composite physical and mental health z-scores were calculated using weighted domain z-scores. Higher z-scores indicate better outcomes, and negative z-scores indicate scores below the population reference mean.
Time frame: Up to 12 weeks after surgery
Patient Palliative Symptoms Assessment
Patient will be assessed for twelve symptoms (pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, constipation, financial distress, and spiritual pain) using a modified Edmonton Symptom Assessment System (ESAS). Each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity.
Time frame: Up to 12 weeks after surgery
Patient Spiritual Assessment 12 Weeks After Surgery
Patient spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp-12); 12 item Spiritual Well-being Scale. Score range: 0 to 48; higher scores correspond to better spiritual well-being.
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Ohio State University Medical Center
Columbus, Ohio, United States
Time frame: Up to 12 weeks after surgery
Patient Prognostic Awareness Assessment Assessment 12 Weeks After Surgery
Patient prognostic awareness is determined based on the Cancer Care Outcomes Research \& Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. To each question, the respondent replied Very likely, Somewhat likely, A little likely, Not at all likely, or Don't know.
Time frame: Up to 12 weeks after surgery
Patient Mortality up to 6 Months
Number of surviving patients in both arms will be reported at end of 6 months.
Time frame: Up to 6 months after surgery
Caregiver Mood Symptom Assessment at 12 Weeks After Surgery
Caregiver symptoms were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29) version 2.1. PROMIS-29 survey questions were each rated on a 5-point Likert scale (range: 1 to 5, higher scores represent a better outcome). Item responses were converted to PROMIS T-scores per the PROMIS scoring manual (population mean = 50, SD = 10). T-scores were then converted to standardized z-scores using the formula (T-score - 50) / 10. Composite physical and mental health z-scores were calculated using weighted domain z-scores. Higher z-scores indicate better outcomes, and negative z-scores indicate scores below the population reference mean.
Time frame: Up to 12 weeks after surgery
Caregiver Burden Measurement 12 Weeks After Surgery
The Zarit Caregiver Burden Scale (ZBI-12) is a 12-item measure of caregiver burden caring for a patient with chronic illness, focusing on the emotional, physical, and social aspects of caregiving. The questions are ranked on a 5-point Likert scale. The total score is 0-48 a higher score indicates a worse outcome (more caregiver burden).
Time frame: Up to 12 weeks after surgery
Caregiver Spiritual Measure at 12 Weeks
Caregiver spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp-12); 12 item Spiritual Well-being Scale (score range: 0 to 48; higher scores correspond to better spiritual well-being).
Time frame: Up to 12 weeks after surgery
Caregiver Prognostic Awareness Assessment at 12 Weeks
Caregiver prognostic awareness was determined based on the Cancer Care Outcomes Research \& Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. To each question, the respondent replied Very likely, Somewhat likely, A little likely, Not at all likely, or Don't know.
Time frame: Up to 12 weeks after surgery