Surgeon-palliative care team co management
OtherSurgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
NCT Number: NCT03611309
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Stanford University, Stanford, California, United States
The components of surgeon palliative care team co management practices will include Time, Education, Assessments, and Multi disciplinary (TEAM) element.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
The surgeon and surgical team will manage
Time frame: Up to 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 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 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 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
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 6 months after surgery
Number of surviving patients in both arms will be reported at end of 6 months.
Time frame: Up to 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
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 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 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.
Stanford University
Other
A Multi-Center Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (the PERIOP-PC Trial)
Acronym: PERIOP-PC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05462314
Biliary Cancer, Biliary Tract Diseases
New York, United States
View Trial DetailsNCT06263088
Anal Cancer, Anus Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT05411133
Adenocarcinoma, Adenocarcinoma Of Esophagus
Adelaide, Australia
View Trial DetailsNCT04426669
Biliary Tract Diseases, Biliary Tract Neoplasms
Minneapolis, Minnesota, United States
View Trial Details