Quality of LifeNCT02985502
The Comparison of Quality of Life in Patients With Pancreatogenic Diabetes After Pancreatectomy
An observational study of Quality of Life and Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the reason why this form of surgery technique is seldom performed. However, with the progress of medical and surgical care nowadays, patients undergone TP could receive better care in endocrine and exocrine insufficiency. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Quality of Life, Diabetes Mellitus, Pancreatectomy
- What is being tested?
- pancreatogenic diabetes
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2016to Jun 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with pancreatogenic diabetes after total pancreatectomy or pancreaticoduodenectomy
Who may be able to join
- (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent
Who cannot join
- diagnosed with cancer other than pancreatic cancer and under active treatment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hsuan-Ju Kuo, MSN, +886929215939, kuo108041@gmail.com
Shiow-Ching Shun, PhD
About this study
Official title: The Comparison and Association of Fatigue, Self-care Activities and Quality of Life in Patients With Pancreatogenic Diabetes Mellitus After Total Pancreatectomy or Pancreaticoduodenectomy
Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the reason why this form of surgery technique is seldom performed. However, with the progress of medical and surgical care nowadays, patients undergone TP could receive better care in endocrine and exocrine insufficiency. In addition, with better understanding of benign pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the quality of life of patients with pancreatogenic diabetes after TP is still currently controversial.
Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care activities and quality of life in patients with pancreatogenic diabetes after total pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.
Read more
Method: A correlational and comparative cross-sectional approach will be used. The data will be collected with a structured questionnaire via purposive sampling of 120 subjects in an outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent. Exclusion criteria will be the patients diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go through propensity score matching and will be analyzed by using descriptive statistics, paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.
Anticipated achievement: The anticipated achievement of this study is to understand the relationships between fatigue, self-care activities, and quality of life in patients with pancreatogenic diabetes after pancreas surgery. In addition, through this study, the influence of diabetes to patients after pancreatic tumor resection can be explored; and the factors that influence the population's quality of life can be examined. By the filling of this knowledge gap, intervention can be planned accordingly to help improve the population's quality of life.
- Conditions
- Quality of Life, Diabetes Mellitus, Pancreatectomy
- Being tested
- pancreatogenic diabetes
- Keywords
- Quality of Life, Diabetes Mellitus, Pancreatectomy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatogenic diabetesOther
pancreatogenic diabetes
| Study group | Role | What they receive |
|---|---|---|
| pancreatogenic diabetes | patients with pancreatogenic diabetes after pancreatectomy will be recruited Receives: Other: pancreatogenic diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire
Measured: 1 day at first appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiow-Ching Shun, PhD, Principal investigator, Department of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985502
- Sponsor's protocol ID
- 201611038RINB
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison and Association of Fatigue, Self-care Activities and Quality of Life in Patients With Pancreatogenic Diabetes Mellitus After Total Pancreatectomy or Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT02985502
- Acronym / sponsor ID
- 201611038RINB
- Conditions
- Quality of Life, Diabetes Mellitus, Pancreatectomy
- Keywords
- Quality of Life, Diabetes Mellitus, Pancreatectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- 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.
Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the reason why this form of surgery technique is seldom performed. However, with the progress of medical and surgical care nowadays, patients undergone TP could receive better care in endocrine and exocrine insufficiency. In addition, with better understanding of benign pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the quality of life of patients with pancreatogenic diabetes after TP is still currently controversial.
Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care activities and quality of life in patients with pancreatogenic diabetes after total pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.
Method: A correlational and comparative cross-sectional approach will be used. The data will be collected with a structured questionnaire via purposive sampling of 120 subjects in an outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent. Exclusion criteria will be the patients diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go through propensity score matching and will be analyzed by using descriptive statistics, paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.
Anticipated achievement: The anticipated achievement of this study is to understand the relationships between fatigue, self-care activities, and quality of life in patients with pancreatogenic diabetes after pancreas surgery. In addition, through this study, the influence of diabetes to patients after pancreatic tumor resection can be explored; and the factors that influence the population's quality of life can be examined. By the filling of this knowledge gap, intervention can be planned accordingly to help improve the population's quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatogenic diabetes | – | Other: pancreatogenic diabetespatients with pancreatogenic diabetes after pancreatectomy will be recruited |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with pancreatogenic diabetes after total pancreatectomy or pancreaticoduodenectomy
Key inclusion criteria (1 listed)
- (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to participate in the study and sign informed consent
Key exclusion criteria (1 listed)
- diagnosed with cancer other than pancreatic cancer and under active treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreatogenic diabetespancreatogenic diabetes | Other | pancreatogenic diabetes |
Primary outcome
Quality of Life Questionnaire
Time frame: 1 day at first appointment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
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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.
Shiow-Ching Shun, PhD principal investigator
Department of Nursing, College of Medicine, 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 Quality of Life 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsuan-Ju Kuo, MSN (+886-929215939, kuo108041@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Questionnaire (time frame: 1 day at first appointment). 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 7 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.