PROMs After Pancreatectomy

NCT07173257 | Recruiting

• 1 other identifier: STUDY00002020
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  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

  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

  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

  Baseline, 6, and 12 months after surgery

• Change from Baseline in Brief Resilience Scale (BRS) Score up to 24 Months Post-Operatively

  Baseline, Immediately Post-Op, 3, 6, 12, and 24 months after surgery

Other Outcomes (1)

• Themes Identified from Semi-Structured Patient Interviews on Decision-Making and Quality of Life up to 24 Months Post-Operatively

  Within 24 months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients seen at Hepato-Pancreato-Biliary Surgery Clinics for pancreatic resections will be considered for the study.

You may qualify if:

• Patients \>18 years old who undergo pancreatic resection for any indication of any race, gender, or ethnicity who are fluent in English

You may not qualify if:

• \<18 years old
• Deemed not to have capacity to consent.

Sponsors & Collaborators

• University of Arizona: lead
• Mayo Clinic - Scottsdale/Phoenix, Arizona: collaborator

Study Sites (2)

Mayo Clinic - Phoenix

Phoenix, Arizona, 85054, United States

RECRUITING

The University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis; Pancreatic Cyst

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Cysts

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: September 15, 2025
• Study Start: April 3, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (2)