PROMs After Pancreatectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients >18 years old who undergo pancreatic resection for any indication of any race, gender, or ethnicity who are fluent in English
Disqualifiers
<18 years old
Deemed not to have capacity to consent.
Trial population
All patients seen at Hepato-Pancreato-Biliary Surgery Clinics for pancreatic resections will be considered for the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery2
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
Time frame
Baseline, Immediately Post-op, 3, 6, 12, 18, and 24 months after surgerySecondary outcomes
1
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
Time frame
Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery2
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
Time frame
Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery3
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)
Time frame
Baseline, Immediately Post-Op, 3, 6, 12, 18, and 24 months after surgery4
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
Time frame
Baseline, 6, and 12 months after surgeryOther outcomes
1
Themes Identified from Semi-Structured Patient Interviews on Decision-Making and Quality of Life up to 24 Months Post-Operatively
A subset of participants will be invited to complete semi-structured qualitative interviews exploring decision regret, satisfaction with the surgical decision-making process, and factors influencing post-operative quality of life. Interviews will be transcribed verbatim and analyzed using thematic analysis. Recruitment will continue until thematic saturation is achieved. Unit of Measure: qualitative themes (categories) Metric: number and type of themes identified; frequency of occurrence across participants Aggregation Method: descriptive summary of themes across participants
Time frame
Within 24 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
Mayo Clinic - Scottsdale/Phoenix, Arizona
Collaborator
Source ClinicalTrials.gov