NCT06013228

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

August 22, 2023

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Fatigue Symptom Inventory

    baseline, 3, 6, 9, and 12 months post baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hsuan-Ju Kuo, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

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.

Locations