Operable Pancreatic TumorNCT06013228
Trajectories of Fatigue and Quality of Life in People With Both Operable Pancreatic Tumor and Diabetes Mellitus
An observational study of Operable Pancreatic Tumor and Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Operable Pancreatic Tumor, Diabetes Mellitus
- How many people
- 99 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Aug 2023to 27 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be recruited from a pancreatic surgical outpatient department (OPD) at a medical center located in northern Taiwan.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Pancreatic cancer is a devastating disease, and surgery is one of the treatment options with the goal of curing the disease. However, people with operable pancreatic tumor (OPT) often have a high prevalence of comorbid diabetes mellitus (DM) that is likely to result in increased glucose fluctuation and poor glycemic control. Importantly, 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 for 12 months of follow-up. 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 of follow-up; (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. Guided by the Theory of unpleasant symptoms, this two-year study will use a longitudinal concurrent mixed methods design. Participants will be recruited from an outpatient pancreatic surgical department at a medical center in northern Taiwan using purposive sampling. For the quantitative component, data will be collected using structured questionnaires over five time points (baseline, 3, 6, 9, and 12 months post baseline),The Chinese version of a structured questionnaire, including the demographic and clinical characteristics form, Diabetes Distress Scale, Center for Epidemiological Studies Depression Scale, Multidimensional Scale of Perceived Social Support, Fatigue Symptom Inventory, Summary of Diabetes Self-Care Activities, and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire will be used. For data analysis, latent growth curve modeling under a structural equation modeling framework using Mplus version 8.6 will be performed. A sample of 115 participants with both OPT and DM will be recruited. To illuminate our understanding of the findings from the quantitative component of the study, the qualitative component will use semi-structured qualitative interviews to explore the changes in challenges with diabetes, fatigue, diabetes self-management, diabetes care needs, and quality of life for a subsample of 20 participants who reported their fatigue intensity scores as 4 or more on the Fatigue Symptom Inventory concurrently. Qualitative content analysis will be used to analyze the qualitative data.
- Conditions
- Operable Pancreatic Tumor, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue Symptom Inventory
Measured: baseline, 3, 6, 9, and 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start30 Aug 2023
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operable Pancreatic TumorStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsuan-Ju Kuo, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013228
- Sponsor's protocol ID
- 202302123RIND
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06013228
- Acronym / sponsor ID
- 202302123RIND
- Conditions
- Operable Pancreatic Tumor, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatic cancer is a devastating disease, and surgery is one of the treatment options with the goal of curing the disease. However, people with operable pancreatic tumor (OPT) often have a high prevalence of comorbid diabetes mellitus (DM) that is likely to result in increased glucose fluctuation and poor glycemic control. Importantly, 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 for 12 months of follow-up. 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 of follow-up; (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. Guided by the Theory of unpleasant symptoms, this two-year study will use a longitudinal concurrent mixed methods design. Participants will be recruited from an outpatient pancreatic surgical department at a medical center in northern Taiwan using purposive sampling. For the quantitative component, data will be collected using structured questionnaires over five time points (baseline, 3, 6, 9, and 12 months post baseline),The Chinese version of a structured questionnaire, including the demographic and clinical characteristics form, Diabetes Distress Scale, Center for Epidemiological Studies Depression Scale, Multidimensional Scale of Perceived Social Support, Fatigue Symptom Inventory, Summary of Diabetes Self-Care Activities, and the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire will be used. For data analysis, latent growth curve modeling under a structural equation modeling framework using Mplus version 8.6 will be performed. A sample of 115 participants with both OPT and DM will be recruited. To illuminate our understanding of the findings from the quantitative component of the study, the qualitative component will use semi-structured qualitative interviews to explore the changes in challenges with diabetes, fatigue, diabetes self-management, diabetes care needs, and quality of life for a subsample of 20 participants who reported their fatigue intensity scores as 4 or more on the Fatigue Symptom Inventory concurrently. Qualitative content analysis will be used to analyze the qualitative data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited from a pancreatic surgical outpatient department (OPD) at a medical center located in northern Taiwan.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue
Time frame: baseline, 3, 6, 9, and 12 months post baseline
Fatigue Symptom Inventory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsuan-Ju Kuo, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Operable Pancreatic Tumor and Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: baseline, 3, 6, 9, and 12 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.