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2018-09-25
2022-08-31
2022-08-31
378
NCT03611309
Stanford University
Stanford University
INTERVENTIONAL
Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-07-25 | N/A | 2023-11-27 |
2018-07-31 | N/A | 2023-11-29 |
2018-08-02 | N/A | 2023-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Surgeon-palliative care team co-management In the Surgeon-palliative care team co-management arm, all patients receive the surgical care of surgeon alone management, which includes surgeon and the surgical team. In addition to this surgeon alone care, palliative care will also be provided by a spe | OTHER: Surgeon-palliative care team co management
|
| OTHER: Surgeon alone management The surgeon and surgical team will manage symptoms, psychosocial support, and prognostic related communication. The surgeon and surgical team care for the patient and their family both prior to and following surgery. The surgeon team is given guidelines p | OTHER: Surgeon team alone management
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Patient mortality | Number of surviving patients in both arms will be reported at end of 6 months. | Up to 6 months after surgery |
| 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 |
| 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 |
| 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
