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Recruiting NCT07173257

PROMs After Pancreatectomy

— Observational Pancreas Neoplasms Pancreatitis Pancreatic Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pancreas Neoplasms, Pancreatitis, Pancreatic Cyst. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Patient Reported Outcomes Measures in Patients Undergoing Pancreatic Resections

Overview

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.

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Mayo Clinic - Phoenix — Phoenix
  • The University of Arizona — Tucson

Identifiers

NCT: NCT07173257 · STUDY00002020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗