Pancreas NeoplasmsPERSPECTIVENCT07173257
PROMs After Pancreatectomy
An observational study of Pancreas Neoplasms and Pancreatitis, run by University of Arizona at 2 sites in United States.
Trial summary
The standard of care for a patient with resectable pancreatic is to perform pancreatic resection which, even in the modern era is associated with significant complications and impact on quality of life, often in the setting of poor survival even in the best scenario. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasms, Pancreatitis, Pancreatic Cyst
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Apr 2023to Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients seen at Hepato-Pancreato-Biliary Surgery Clinics for pancreatic resections will be considered for the study.
Who may be able to join
- Patients >18 years old who undergo pancreatic resection for any indication of any race, gender, or ethnicity who are fluent in English
Who cannot join
- <18 years old
- Deemed not to have capacity to consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
Paul Hong, MD, 602-490-9701, Hong.Tanpo@mayo.edu
Zhi V. Fong, MD, MPH
- Recruiting
The University of Arizona
Tucson, Arizona, 85724
Nicholas Galouzis, MD, 520-626-7754, galouzis@arizona.edu
Maria Fotinos, B.S., 520-621-3023, mariakhawam@arizona.edu
About this study
Official title: Patient Reported Outcomes Measures in Patients Undergoing Pancreatic Resections
The standard of care for a patient with resectable pancreatic is to perform pancreatic resection which, even in the modern era is associated with significant complications and impact on quality of life, often in the setting of poor survival even in the best scenario. Currently, there is a lack of data on patient quality of life after such procedures, how quality of life changes throughout the course of care, and whether patients who undergo these procedures are satisfied with their decision. This research is aimed to understand the impact of pancreatic surgery on patients' quality of life, how that impact changes over time, and patient satisfaction (or regret) with their decisions. This work will help improve the pre-operative conversation to help patients decide whether undergoing a pancreatic resection aligns with their post-operative goals of care.
- Conditions
- Pancreas Neoplasms, Pancreatitis, Pancreatic Cyst
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Pancreatic Cyst
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Quality of Life Measured by EORTC QLQ-C30 Scale up to 24 Months Post-Operatively
The EORTC QLQ-C30 is a validated 30-item questionnaire assessing cancer-specific quality of life. The Global Health Status/QoL scale ranges from 0 to 100, with higher scores representing better quality of life.
Unit of Measure: points Metric: Mean change from baseline Aggregation Method: Mean (SD) across participants
Measured: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic Cancer Module (EORTC QLQ-PAN26) Subscale Scores up to 24 Months Post-Operatively
The EORTC QLQ-PAN26 is a 26-item, disease-specific questionnaire designed for patients with pancreatic cancer. It is used alongside the core EORTC QLQ-C30. PAN26 assesses multiple domains, including pancreatic pain, digestive symptoms, altered bowel habits, hepatic symptoms, and emotional effects. Each subscale is linearly transformed to a score from 0 to 100.
For symptom subscales, higher scores = worse symptoms. For functioning domains, higher scores = greater impairment.
Unit of Measure: points (0-100) per subscale Metric: mean change from baseline Aggregation: mean (SD) across participants
Measured: Baseline, Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery
Secondary outcomes (10)
Change from Baseline in Social Functioning (PROMIS) up to 24 Months Post-Operatively
PROMIS Social Isolation 8a Short Form T-score (higher = more isolation), change from baseline
Measured: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change from Baseline in Emotional Functioning (PROMIS) up to 24 Months Post-Operatively
PROMIS Depression 4a Short Form T-score (mean 50, SD 10; higher = more depressive symptoms), change from baseline up to 24 months post-operatively
Measured: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change from Baseline in Shared Decision-Making up to 24 Months Post-Operatively
Change from Baseline in Shared Decision Making Questionnaire (SDM-Q-9) Score (0-100; higher = better) up to 24 months post-operatively
Unit: points Metric: mean change from baseline Aggregation: mean (SD)
Measured: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change from Baseline in Grit Scale (Duckworth 12-item) Total Score up to 12 Months Post-Operatively
The Grit Scale is a 12-item validated self-report questionnaire that measures perseverance of effort and consistency of interests. Each item is scored from 1 ("Not at all like me") to 5 ("Very much like me"). Total scores are averaged, yielding a range of 1 to 5, with higher scores indicating greater grit.
Unit of Measure: points (1-5) Metric: mean change from baseline Aggregation: mean (SD) across participants
Measured: Baseline, 6, and 12 months after surgery
Change from Baseline in Brief Resilience Scale (BRS) Score up to 24 Months Post-Operatively
The Brief Resilience Scale (BRS) is a validated 6-item self-report measure assessing an individual's ability to "bounce back" from stressful events. Items are rated on a 5-point Likert scale: 1 = Strongly Disagree to 5 = Strongly Agree. After reverse-coding negatively worded items (Items 2, 4, 6), the mean of the six items is computed, yielding a score from 1.00 to 5.00: higher values reflect greater resilience.
Unit of Measure: points (mean score) Metric: mean change from baseline Aggregation: mean (SD) across participants
Measured: Baseline, Immediately Post-Op, 3, 6, 12, and 24 months after surgery
Change from Baseline in COST-FACIT (Comprehensive Score for Financial Toxicity) Score up to 24 Months Post-Operatively
The Comprehensive Score for Financial Toxicity (COST-FACIT) is an 11-item validated questionnaire that assesses the financial distress related to medical treatment. Scores range from 0 to 44, with lower scores indicating greater financial toxicity and higher scores indicating better financial well-being.
Unit of Measure: points (0-44) Metric: mean change from baseline Aggregation: mean (SD) across participants
Measured: Baseline, Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery
Change in Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) Total Score up to 24 Months Post-Operatively
The Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) is a 9-item validated self-report measure assessing concerns about cancer recurrence. Each item is scored on a 5-point Likert scale, yielding a total score between 0 and 36. Higher scores indicate greater fear of recurrence.
Unit of Measure: points (0-36) Metric: mean change from baseline Aggregation: mean (SD) across participants
Measured: Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery
Change in Patient Decision Regret Scale (Brehaut et al., 2003) Total Score up to 24 Months Post-Operatively
The Decision Regret Scale (Brehaut et al., 2003) is a validated 5-item questionnaire that assesses regret after health care decisions. Each item is scored on a 5-point Likert scale and transformed to a total score from 0 (no regret) to 100 (high regret), with higher scores reflecting greater regret.
Units: Points (0-100) Metric: mean change from immediately post-op Aggregation: Mean (SD)
Measured: Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change in Surgeon Decision Regret Scale (Brehaut et al., 2003) Total Score up to 12 Months Post-Operatively
The Decision Regret Scale (Brehaut et al., 2003) is a validated 5-item questionnaire that assesses regret after health care decisions. Each item is scored on a 5-point Likert scale and transformed to a total score from 0 (no regret) to 100 (high regret), with higher scores reflecting greater regret.
Units: Points (0-100) Metric: mean change from immediately post-op Aggregation: Mean (SD)
Measured: Immediately Post-Op, 3, and 12 months after surgery
Change from Baseline in Neuropathy Symptom Scores Using NCI PRO-CTCAE® Custom Item Subset up to 24 Months Post-Operatively
Neuropathy symptoms will be assessed using a custom subset of items from the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) v1.0 Item Library. Items address neuropathy-related domains such as numbness, tingling, pain, and interference with daily activities. Each item is scored on a 5-point Likert scale (0 = None, 4 = Very severe / Almost always / Very much). Scores can be analyzed individually or averaged per domain. Higher scores indicate greater symptom severity, frequency, or interference.
Unit of Measure: points (0-4 per item) Metric: mean change from baseline Aggregation: mean (SD) across participants; frequency distribution of severity levels
Measured: Baseline, 3, 6, 12, 18, and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start3 Apr 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic - Scottsdale/Phoenix, Arizona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173257
- Sponsor's protocol ID
- STUDY00002020
- Acronym
- PERSPECTIVE
- Status last verified
- Sep 2025
- First submitted
- 27 Mar 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes Measures in Patients Undergoing Pancreatic Resections
- ClinicalTrials.gov ID
- NCT07173257
- Acronym / sponsor ID
- PERSPECTIVE / STUDY00002020
- Conditions
- Pancreas Neoplasms, Pancreatitis, Pancreatic Cyst
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Mayo Clinic - Scottsdale/Phoenix, Arizona
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard of care for a patient with resectable pancreatic is to perform pancreatic resection which, even in the modern era is associated with significant complications and impact on quality of life, often in the setting of poor survival even in the best scenario. Currently, there is a lack of data on patient quality of life after such procedures, how quality of life changes throughout the course of care, and whether patients who undergo these procedures are satisfied with their decision. This research is aimed to understand the impact of pancreatic surgery on patients' quality of life, how that impact changes over time, and patient satisfaction (or regret) with their decisions. This work will help improve the pre-operative conversation to help patients decide whether undergoing a pancreatic resection aligns with their post-operative goals of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients seen at Hepato-Pancreato-Biliary Surgery Clinics for pancreatic resections will be considered for the study.
Key inclusion criteria (1 listed)
- Patients >18 years old who undergo pancreatic resection for any indication of any race, gender, or ethnicity who are fluent in English
Key exclusion criteria (2 listed)
- <18 years old
- Deemed not to have capacity to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Quality of Life Measured by EORTC QLQ-C30 Scale up to 24 Months Post-Operatively
Time frame: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
The EORTC QLQ-C30 is a validated 30-item questionnaire assessing cancer-specific quality of life. The Global Health Status/QoL scale ranges from 0 to 100, with higher scores representing better quality of life. Unit of Measure: points Metric: Mean change from baseline Aggregation Method: Mean (SD) across participants
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic Cancer Module (EORTC QLQ-PAN26) Subscale Scores up to 24 Months Post-Operatively
Time frame: Baseline, Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery
The EORTC QLQ-PAN26 is a 26-item, disease-specific questionnaire designed for patients with pancreatic cancer. It is used alongside the core EORTC QLQ-C30. PAN26 assesses multiple domains, including pancreatic pain, digestive symptoms, altered bowel habits, hepatic symptoms, and emotional effects. Each subscale is linearly transformed to a score from 0 to 100. For symptom subscales, higher scores = worse symptoms. For functioning domains, higher scores = greater impairment. Unit of Measure: points (0-100) per subscale Metric: mean change from baseline Aggregation: mean (SD) across participants
10 secondary outcomes
Change from Baseline in Social Functioning (PROMIS) up to 24 Months Post-Operatively
Time frame: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change from Baseline in Emotional Functioning (PROMIS) up to 24 Months Post-Operatively
Time frame: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change from Baseline in Shared Decision-Making up to 24 Months Post-Operatively
Time frame: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change from Baseline in Grit Scale (Duckworth 12-item) Total Score up to 12 Months Post-Operatively
Time frame: Baseline, 6, and 12 months after surgery
Change from Baseline in Brief Resilience Scale (BRS) Score up to 24 Months Post-Operatively
Time frame: Baseline, Immediately Post-Op, 3, 6, 12, and 24 months after surgery
Change from Baseline in COST-FACIT (Comprehensive Score for Financial Toxicity) Score up to 24 Months Post-Operatively
Time frame: Baseline, Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery
Change in Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) Total Score up to 24 Months Post-Operatively
Time frame: Immediately Post-op, 3, 6, 12, 18, and 24 months after surgery
Change in Patient Decision Regret Scale (Brehaut et al., 2003) Total Score up to 24 Months Post-Operatively
Time frame: Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery
Change in Surgeon Decision Regret Scale (Brehaut et al., 2003) Total Score up to 12 Months Post-Operatively
Time frame: Immediately Post-Op, 3, and 12 months after surgery
Change from Baseline in Neuropathy Symptom Scores Using NCI PRO-CTCAE® Custom Item Subset up to 24 Months Post-Operatively
Time frame: Baseline, 3, 6, 12, 18, and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Neoplasms and Pancreatitis, run by University of Arizona at 2 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Quality of Life Measured by EORTC QLQ-C30 Scale up to 24 Months Post-Operatively (time frame: Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.