Gastrointestinal CancerPERIOP-PCNCT03611309
Perioperative Palliative Care Surrounding Cancer Surgery for Patients & Their Family Members
A study testing Surgeon-palliative care team co management and Surgeon team alone management in people with Gastrointestinal Cancer, run by Stanford University at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Surgeon-palliative care team co management and Surgeon team alone management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Sep 2018to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No previous involvement of palliative care providers in their care course
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Johns Hopkins Hostpital
Baltimore, Maryland, 21287
Dana Farber/ Brigham
Boston, Massachusetts, 02115
Ohio State University Medical Center
Columbus, Ohio, 43210
Stanford University
Stanford, California, 94304
About this study
Official title: A Multi-Center Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (the PERIOP-PC Trial)
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.
Read the detailed description
The components of surgeon palliative care team co management practices will include Time, Education, Assessments, and Multi disciplinary (TEAM) element.
- Time; At least 60 minutes/month (per patient and caregiver preference) devoted to palliative care treatments for the patient and family
- 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
- 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.
- 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.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Surgeon-palliative care team co management, Surgeon team alone management
- Keywords
- Pancreatic Cancer, Hepatocellular Cancer, Esophageal Cancer, Gastric Cancer, Cholangio carcinomas
- Medical subject headings
- Gastrointestinal Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgeon-palliative care team co managementOther
Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
Surgeon team alone managementOther
The surgeon and surgical team will manage
| Study group | Role | What they receive |
|---|---|---|
| Surgeon-palliative care team co-management | Experimental | 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 specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. Receives: Other: Surgeon-palliative care team co management |
| Surgeon alone management | Other | 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 published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended Receives: Other: Surgeon team alone management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks after surgery
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Up to 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start25 Sep 2018
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Karl Lorenz, Stanford University
- Investigators
- Karl Lorenz, MD, MSHS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611309
- Sponsor's protocol ID
- IRB-45805
- Other IDs
- NCI-2018-02183
- Acronym
- PERIOP-PC
- Status last verified
- Dec 2025
- First submitted
- 25 Jul 2018
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holdsworth LM, Siden R, Lessios AS, Verano M, Rickerson E, Fahy B, Johnston FM, Waterman B, Aslakson R. Patient Experiences of Specialty Palliative Care in the Perioperative Period for Cancer Surgery. J Pain Symptom Manage. 2024 Sep;68(3):292-298.e1. doi: 10.1016/j.jpainsymman.2024.06.008. Epub 2024 Jun 19.
PubMed 38906425Aslakson RA, Rickerson E, Fahy B, Waterman B, Siden R, Colborn K, Smith S, Verano M, Lira I, Hollahan C, Siddiqi A, Johnson K, Chandrashekaran S, Harris E, Nudotor R, Baker J, Heidari SN, Poultsides G, Conca-Cheng AM, Cook Chapman A, Lessios AS, Holdsworth LM, Gustin J, Ejaz A, Pawlik T, Miller J, Morris AM, Tulsky JA, Lorenz K, Temel JS, Smith TJ, Johnston F. Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314660. doi: 10.1001/jamanetworkopen.2023.14660.
PubMed 37256623Aslakson RA, Chandrashekaran SV, Rickerson E, Fahy BN, Johnston FM, Miller JA, Conca-Cheng A, Wang S, Morris AM, Lorenz K, Temel JS, Smith TJ. A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC). J Palliat Med. 2019 Sep;22(S1):44-57. doi: 10.1089/jpm.2019.0130.
PubMed 31486730
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (the PERIOP-PC Trial)
- ClinicalTrials.gov ID
- NCT03611309
- Acronym / sponsor ID
- PERIOP-PC / IRB-45805
- Conditions
- Gastrointestinal Cancer
- Keywords
- Pancreatic Cancer, Hepatocellular Cancer, Esophageal Cancer, Gastric Cancer, Cholangio carcinomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 8 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The components of surgeon palliative care team co management practices will include Time, Education, Assessments, and Multi disciplinary (TEAM) element.
- Time; At least 60 minutes/month (per patient and caregiver preference) devoted to palliative care treatments for the patient and family
- 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
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon-palliative care team co-management | Experimental | Other: Surgeon-palliative care team co managementIn 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 specialist team. For patients in this arm, patients and/or family members will be seen by the palliative care team: (1) in an outpatient setting prior to surgery, (2) in the hospital within 72 hours of their initial surgery and as needed afterwards, and (3) via phone on in-clinic (per patient preference) on an at least monthly basis and/or as needed for 12 weeks following surgery. |
| Surgeon alone management | Other | Other: Surgeon team alone managementThe 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 published by the National Cancer Coalition Network as to when palliative care specialist consultation is recommended |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- No previous involvement of palliative care providers in their care course
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgeon-palliative care team co managementSurgeon-palliative care team co management includes surgeon alone care and palliative care specialist team | Other | Surgeon-palliative care team co-management |
| Surgeon team alone managementThe surgeon and surgical team will manage | Other | Surgeon alone management |
Primary outcome
Patient Quality of Life Patient Quality of Life 12 Weeks After Surgery
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.
9 secondary outcomes
Patient Mood Symptoms Assessment 12 Weeks After Surgery
Time frame: Up to 12 weeks after surgery
Patient Palliative Symptoms Assessment
Time frame: Up to 12 weeks after surgery
Patient Spiritual Assessment 12 Weeks After Surgery
Time frame: Up to 12 weeks after surgery
Patient Prognostic Awareness Assessment Assessment 12 Weeks After Surgery
Time frame: Up to 12 weeks after surgery
Patient Mortality up to 6 Months
Time frame: Up to 6 months after surgery
Caregiver Mood Symptom Assessment at 12 Weeks After Surgery
Time frame: Up to 12 weeks after surgery
Caregiver Burden Measurement 12 Weeks After Surgery
Time frame: Up to 12 weeks after surgery
Caregiver Spiritual Measure at 12 Weeks
Time frame: Up to 12 weeks after surgery
Caregiver Prognostic Awareness Assessment at 12 Weeks
Time frame: Up to 12 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38906425Holdsworth LM, Siden R, Lessios AS, Verano M, Rickerson E, Fahy B, Johnston FM, Waterman B, Aslakson R. Patient Experiences of Specialty Palliative Care in the Perioperative Period for Cancer Surgery. J Pain Symptom Manage. 2024 Sep;68(3):292-298.e1. doi: 10.1016/j.jpainsymman.2024.06.008. Epub 2024 Jun 19.
- Derived from this study: PubMed 37256623Aslakson RA, Rickerson E, Fahy B, Waterman B, Siden R, Colborn K, Smith S, Verano M, Lira I, Hollahan C, Siddiqi A, Johnson K, Chandrashekaran S, Harris E, Nudotor R, Baker J, Heidari SN, Poultsides G, Conca-Cheng AM, Cook Chapman A, Lessios AS, Holdsworth LM, Gustin J, Ejaz A, Pawlik T, Miller J, Morris AM, Tulsky JA, Lorenz K, Temel JS, Smith TJ, Johnston F. Effect of Perioperative Palliative Care on Health-Related Quality of Life Among Patients Undergoing Surgery for Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314660. doi: 10.1001/jamanetworkopen.2023.14660.
- Derived from this study: PubMed 31486730Aslakson RA, Chandrashekaran SV, Rickerson E, Fahy BN, Johnston FM, Miller JA, Conca-Cheng A, Wang S, Morris AM, Lorenz K, Temel JS, Smith TJ. A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC). J Palliat Med. 2019 Sep;22(S1):44-57. doi: 10.1089/jpm.2019.0130.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Lorenz, MD, MSHS principal investigator
Stanford University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgeon-palliative care team co management and Surgeon team alone management in people with Gastrointestinal Cancer, run by Stanford University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Quality of Life Patient Quality of Life 12 Weeks After Surgery (time frame: Up to 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611309, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.