Trajectories of Fatigue and Quality of Life in People With Both Operable Pancreatic Tumor and Diabetes Mellitus
Trajectories of Fatigue, Glycated Hemoglobin, Diabetes Self-management, and Quality of Life in People With a Dual Diagnosis of Operable Pancreatic Tumor and Diabetes Mellitus: A Longitudinal Mixed-methods Study
1 other identifier
observational
99
1 country
1
Brief Summary
In people with both burdens of OPT and DM, fatigue is the most common and deliberating symptom that likely impacts their quality of life and diabetes self-management. However, little is known about the longitudinal relationships among fatigue, its influencing factors, glycemic status, diabetes self-management, and quality of life in people with both OPT and DM during the first-year post-operation. Thus, the purposes of this study are to (1) describe the trajectories of fatigue, HbA1c, diabetes self-management, and quality of life in people with OPT and DM within 12 months post-operation; (2) examine the relationships among the trajectories of fatigue, its influencing factors, diabetes self-management, and quality of life in people with OPT and DM; and (3) understand the experiences of people with both OPT and DM regarding changes in challenges with diabetes, fatigue, diabetes self-management, diabetes care needs, and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedStudy Start
First participant enrolled
August 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2026
CompletedApril 29, 2026
April 1, 2026
2.6 years
August 22, 2023
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Fatigue
Fatigue Symptom Inventory
baseline, 3, 6, 9, and 12 months post baseline
Eligibility Criteria
The participants will be recruited from a pancreatic surgical outpatient department (OPD) at a medical center located in northern Taiwan.
You may qualify if:
- Operable pancreatic tumor within 5 years and are following up at the outpatient department
- Diagnosed with diabetes mellitus
- Aged 18 or above
- Can communicate in Mandarin or Taiwanese
- Agree to participate and sign the informed consent form
You may not qualify if:
- Under active treatment for cancer other than pancreatic tumor
- Have a cognitive impairment
- Do not know that they have pancreatic tumor
- Diagnosed with chronic fatigue syndrome or fibromyalgia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hsuan-Ju Kuo, PhD
National Taiwan University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2023
First Posted
August 28, 2023
Study Start
August 30, 2023
Primary Completion
March 27, 2026
Study Completion
March 27, 2026
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will only be available to other researchers on reasonable request and only de-identified data will potentially be available to protect the rights of the participants.