Chronic PancreatitisNCT05489003
Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
This study will investigate the status of fatigue, psychological comorbidity and quality of life among patients with chronic pancreatitis in China and analyze their influencing factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2023
- 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: Patients with chronic pancreatitis in China.
Who may be able to join
- Clinical diagnosis of chronic pancreatitis
Who cannot join
- Illiterate
- Having communication difficulties
- Unable to complete the questionnaires
- Having a history of psychiatric disorders
- Recent history of psychotropic and sedative drug use
- Pregnancy
- Rejected participants
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
Liang-Hao Hu, +8613817593520, lianghai-hu@smmu.edu.cn
You Zhou, MD
About this study
This study will investigate the status of fatigue, psychological comorbidity and quality of life among patients with chronic pancreatitis in China and analyze their influencing factors.
Read the detailed description
Chronic pancreatitis (CP) is an inflammatory disease characterized by pancreatic fibrosis. Available studies suggested that the incidence of CP in China was about 13.5 per 100,000 people. Patients with CP often have symptoms of pancreatic endocrine and exocrine insufficiency such as elevated blood sugar, weight loss, muscle loss, combined with complications such as pancreatic duct stones, pancreatic duct stenosis, pancreatic pseudocysts, and have a higher risk of pancreatic cancer, which seriously affects the quality of life of patients.
Psychological comorbidities represented by anxiety and depression were thought to be widespread in CP patients, with available epidemiological studies indicating that the prevalence of anxiety and depression in CP patients in the United States was 36.8% and 46.8%, respectively. In addition, fatigue, as a subjective perception of decreased ability to perform physical and/or intellectual tasks, has also been founded among CP patients.
However, to date, there is a lack of epidemiological studies on fatigue, anxiety, depression and quality of life in Chinese patients with CP. This study will investigate the epidemiological status of fatigue, anxiety, depression, and quality of life in Chinese patients with CP and analyze the factors influencing them.
- Conditions
- Chronic Pancreatitis
- Keywords
- Chronic pancreatitis, Fatigue, Anxiety, Depression, Quality of life
- Medical subject headings
- Pancreatitis, Chronic, Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with fatigue | Chronic pancreatitis patients with fatigue measured by professional assessment scales. | |
| Patients without fatigue | Chronic pancreatitis patients without fatigue measured by professional assessment scales. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of fatigue among patients with CP in China.
The level of fatigue in CP patients was measured using the Multidimensional Fatigue Inventory (MFI-20), and the Fatigue Severity Scale (FSS).
Measured: Within 1 month after data analysis.
The incidence of anxiety among patients with CP in China.
The level of anxiety in CP patients is measured using the Hospital Anxiety and Depression Scale (HADS), and the Zung Self-Rating Anxiety Scale (SAS).
Measured: Within 1 month after data analysis.
The incidence of depression among patients with CP in China.
The level of anxiety in CP patients is measured using the Hospital Anxiety and Depression Scale (HADS), and the Zung Self-rating Depression Scale (SDS).
Measured: Within 1 month after data analysis.
The incidence of quality of life among patients with CP in China.
The level of quality of life in CP patients is measured using the European organization for the research and treatment of cancer QOL questionnaire (EORTC-QLQ C-30).
Measured: Within 1 month after data analysis.
Secondary outcomes (4)
The influencing factors of fatigue among patients with CP in China.
Factors included are obtained from the patient's electronic medical record or by asking the patient directly. The content mainly included (1) sociodemographic data: age, gender, education level, income level, marital status, social support level, and patient's life history (smoking and alcohol consumption), etc; (2) clinical data of CP: first symptoms, frequency of abdominal pain, severity of pain, and times of hospitalization for acute pancreatitis, etc; and (3) patient's psychological conditions: the level of anxiety and depression.
Measured: Within 1 month after data analysis.
The influencing factors of anxiety and depression among patients with CP in China.
Factors included are obtained from the patient's electronic medical record or by asking the patient directly. The content mainly included (1) sociodemographic data: age, gender, education level, income level, marital status, social support level, and patient's life history (smoking and alcohol consumption), etc; (2) clinical data of CP: first symptoms, frequency of abdominal pain, severity of pain, and times of hospitalization for acute pancreatitis, etc.
Measured: Within 1 month after data analysis.
The influencing factors of depression among patients with CP in China.
Factors included are obtained from the patient's electronic medical record or by asking the patient directly. The content mainly included (1) sociodemographic data: age, gender, education level, income level, marital status, social support level, and patient's life history (smoking and alcohol consumption), etc; (2) clinical data of CP: first symptoms, frequency of abdominal pain, severity of pain, and times of hospitalization for acute pancreatitis, etc.
Measured: Within 1 month after data analysis.
The influencing factors of quality of life among patients with CP in China.
Factors included are obtained from the patient's electronic medical record or by asking the patient directly. The content mainly included (1) sociodemographic data: age, gender, education level, income level, marital status, social support level, and patient's life history (smoking and alcohol consumption), etc; (2) clinical data of CP: first symptoms, frequency of abdominal pain, severity of pain, and times of hospitalization for acute pancreatitis, etc; and (3) patient's psychological conditions: the level of anxiety and depression.
Measured: Within 1 month after data analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-Hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489003
- Sponsor's protocol ID
- XH20220802
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue, Psychological Comorbidity and Quality of Life Among Patients With Chronic Pancreatitis in China.
- ClinicalTrials.gov ID
- NCT05489003
- Acronym / sponsor ID
- XH20220802
- Conditions
- Chronic Pancreatitis
- Keywords
- Chronic pancreatitis, Fatigue, Anxiety, Depression, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Aug 2022 (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.
This study will investigate the status of fatigue, psychological comorbidity and quality of life among patients with chronic pancreatitis in China and analyze their influencing factors.
Detailed description
Chronic pancreatitis (CP) is an inflammatory disease characterized by pancreatic fibrosis. Available studies suggested that the incidence of CP in China was about 13.5 per 100,000 people. Patients with CP often have symptoms of pancreatic endocrine and exocrine insufficiency such as elevated blood sugar, weight loss, muscle loss, combined with complications such as pancreatic duct stones, pancreatic duct stenosis, pancreatic pseudocysts, and have a higher risk of pancreatic cancer, which seriously affects the quality of life of patients.
Psychological comorbidities represented by anxiety and depression were thought to be widespread in CP patients, with available epidemiological studies indicating that the prevalence of anxiety and depression in CP patients in the United States was 36.8% and 46.8%, respectively. In addition, fatigue, as a subjective perception of decreased ability to perform physical and/or intellectual tasks, has also been founded among CP patients.
However, to date, there is a lack of epidemiological studies on fatigue, anxiety, depression and quality of life in Chinese patients with CP. This study will investigate the epidemiological status of fatigue, anxiety, depression, and quality of life in Chinese patients with CP and analyze the factors influencing them.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with fatigue | – | –Chronic pancreatitis patients with fatigue measured by professional assessment scales. |
| Patients without fatigue | – | –Chronic pancreatitis patients without fatigue measured by professional assessment scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pancreatitis in China.
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic pancreatitis
Key exclusion criteria (7 listed)
- Illiterate
- Having communication difficulties
- Unable to complete the questionnaires
- Having a history of psychiatric disorders
- Recent history of psychotropic and sedative drug use
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
The incidence of fatigue among patients with CP in China.
Time frame: Within 1 month after data analysis.
The level of fatigue in CP patients was measured using the Multidimensional Fatigue Inventory (MFI-20), and the Fatigue Severity Scale (FSS).
The incidence of anxiety among patients with CP in China.
Time frame: Within 1 month after data analysis.
The level of anxiety in CP patients is measured using the Hospital Anxiety and Depression Scale (HADS), and the Zung Self-Rating Anxiety Scale (SAS).
The incidence of depression among patients with CP in China.
Time frame: Within 1 month after data analysis.
The level of anxiety in CP patients is measured using the Hospital Anxiety and Depression Scale (HADS), and the Zung Self-rating Depression Scale (SDS).
The incidence of quality of life among patients with CP in China.
Time frame: Within 1 month after data analysis.
The level of quality of life in CP patients is measured using the European organization for the research and treatment of cancer QOL questionnaire (EORTC-QLQ C-30).
4 secondary outcomes
The influencing factors of fatigue among patients with CP in China.
Time frame: Within 1 month after data analysis.
The influencing factors of anxiety and depression among patients with CP in China.
Time frame: Within 1 month after data analysis.
The influencing factors of depression among patients with CP in China.
Time frame: Within 1 month after data analysis.
The influencing factors of quality of life among patients with CP in China.
Time frame: Within 1 month after data analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Liang-Hao Hu, MD principal investigator
Changhai Hospital
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 Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
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 7 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 16 Aug 2022. 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 China. 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 Liang-Hao Hu, MD (+8613817593520, lianghao-hu@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of fatigue among patients with CP in China. (time frame: Within 1 month after data analysis.). The study lists 4 primary outcomes in all. 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 16 Aug 2022.