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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611309
Other study ID # IRB-45805
Secondary ID GI0020
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2018
Est. completion date August 31, 2022

Study information

Verified date November 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 378
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age and must be able to give informed consent. - Diagnosed with pancreatic cancer or hepatocellular cancer or esophageal cancer or gastric cancer and/or cholangio carcinomas - Non emergent, upper gastrointestinal cancer related surgery with a goal of primary resection of the tumor- optimal surgical goal is cure, not merely disease palliation. - One companion per patient will be allowed to participate. In addition, to being identified by the patient at being a key caregiver throughout the surgery period, these companions must be able to give informed consent and at least 18 years of age. Exclusion Criteria: - No previous involvement of palliative care providers in their care course

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Surgeon-palliative care team co management
Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
Surgeon team alone management
The surgeon and surgical team will manage

Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Johns Hopkins Hostpital Baltimore Maryland
United States Dana Farber/ Brigham Boston Massachusetts
United States Ohio State University Medical Center Columbus Ohio
United States Stanford University Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient quality of life 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. The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
Secondary Patient mood symptoms assessment Patient symptoms will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29) version 2.0. The PROMIS-29 is health-related quality of life survey which assesses each of the 7 PROMIS domains (pain, fatigue, depression, anxiety, sleep, physical function and sexual function) with 4 questions. The questions are ranked on a 5-point Likert Scale and 11 point rating scale for pain intensity. The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
Secondary 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. The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
Secondary Patient spiritual assessment Patient spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being; 12 item Spiritual Well-being Scale (FACIT-Sp-12). It is a 12 item questionnaire. The questions are ranked on a 4-point Likert Scale. The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
Secondary Patient prognostic awareness assessment Patient prognostic awareness is determined based on the Cancer Care Outcomes Research & Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. The questions are ranked on a 5-point Likert Scale. The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
Secondary Patient mortality Number of surviving patients in both arms will be reported at end of 6 months. Up to 6 months after surgery
Secondary Caregiver mood symptom assessment Caregiver symptoms will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29). The PROMIS-29 is health-related quality of life survey which assesses each of the 7 PROMIS domains (pain, fatigue, depression, anxiety, sleep, physical function and sexual function) with 4 questions. The questions are ranked on a 5-point Likert Scale and 11 point rating scale for pain intensity. The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
Secondary Caregiver burden measurement Caregiver burden symptoms will be measured by Zarit Caregiver Burden Scale (ZBI-12) which measures 12 items ( 0-4 points per item, total score of 0-48). The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
Secondary Caregiver spiritual measure Caregiver spiritual symptoms assessment will be assessed using Functional Assessment of Chronic Illness Therapy - Spiritual Well-being; 12 item Spiritual Well-being Scale (FACIT-Sp-12). It is a 12 item questionnaire. The questions are ranked on a 4-point Likert Scale. The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
Secondary Caregiver prognostic awareness assessment Caregiver prognostic awareness is determined based on the Cancer Care Outcomes Research & Surveillance Consortium (CANCORS) study prognostic awareness questions before and after surgery. The questions are ranked on a 5-point Likert Scale. The outcome will be reported as the median value per group, with full range. Up to 12 weeks after surgery
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