Pancreatitis, ChronicNCT05940987
Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis.(START)
A study testing Phone-based smoking cessation intervention in people with Pancreatitis, Chronic, run by Changhai Hospital at 1 site in China.
Trial summary
This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their smoking cessation rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Chronic
- What is being tested?
- Phone-based smoking cessation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to 25 Feb 2025
- Phase
- Interventional
- 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
Who may be able to join
- 1.18 years of age and older living; 2.Patients diagnosed as chronic pancreatitis; 3.Self-reported smoking ≥ 5 cigarettes; 4.Urine cotinine levels ≥ 200 ng/mL; 5.Owning a phone; 6.Willing to provide informed consent to participate in the study.
Who cannot join
- Patients diagnosed as pancreatic cancer within 2 years after diagnosing chronic pancreatitis; Patients diagnosed as groove pancreatitis or autoimmune pancreatitis;
- Pregnant or lactating women;
- Patients with life expectancy ≤ 12 months;
- Comorbidities such as Alzheimer's disease, end-stage cancer, HIV, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease, uncompensated cirrhosis, renal failure;
- Smoking e-cigarettes or other forms of non-burning tobacco.
- Patients refused to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis ：a Prospective Multicenter Randomized Clinical Trial
This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their smoking cessation rate.
Read the detailed description
Chronic pancreatitis（CP） is a chronically progressive disease characterized by pancreatic fibrosis and inflammation, and its basic pathological features include chronic inflammatory damage to the pancreatic parenchyma, interstitial fibrosis, pancreatic parenchymal calcification, pancreatic duct dilation, and pancreatic duct stones.
Environmental factors such as alcoholism，smoking and genetic factors are the main causative factors of CP. Clinical studies have found that smoking can not only accelerate the course of CP, but also increase the risk of CP-related complications. Some scholars believe that smoking cessation may be a potential way to prevent the progression of CP and improve the prognosis of CP. Although there is no evidence to verify whether smoking cessation will improve the clinical course of CP, the latest ACG Clinical Guideline strongly recommends CP patients quit smoking.
In 2016，a prospective study of smoking cessation interventions in CP patients showed that 27 enrolled patients had a smoking cessation rate of 0% after 6 months of smoking cessation intervention, indicating that smoking cessation is a huge challenge for CP patients.
The investigators propose to conduct a randomized controlled trial to investigate the effects of telephone intervention on smoking cessation in patients with CP and explore the impact of smoking cessation on their clinical course and prognosis.
- Conditions
- Pancreatitis, Chronic
- Being tested
- Phone-based smoking cessation intervention
- Keywords
- Smoking Cessation, Phone-based intervention
- Medical subject headings
- Pancreatitis, Chronic, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone-based smoking cessation interventionBehavioural
Participants who allocate to the intervention group will receive regular phone-based smoking cessation intervention by professional team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will receive one 20-30 minutes "5A" smoking cessation health consultation after enrollment; They will be given regular phone-based smoking cessation intervention once a week in the first month and once a month thereafter (15 times in total). Participants will be followed at 2, 6, 12 months, and cotinine urine test kits will be mailed to those who have self-reported smoking cessation at follow-up, which is used to confirm whether they have quitted smoking or not. (smoking cessation is defined as urine cotinine levels below 200 ng/mL). Receives: Behavioral: Phone-based smoking cessation intervention |
| Control Group | No intervention | Participants in the control group will receive one 20-30 minute "5A" smoking cessation health consultation after enrollment; Phone-based smoking cessation intervention will not be regularly given after enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Validated of 7-day Point Abstinence
The primary outcome will be biochemical validation of Self-reported 7-day point-prevalence abstinence at month 12 after quit date.
Measured: 12 months
Secondary outcomes (3)
Self-reported 7-day Point Abstinence
Self-reported 7-day point-prevalence abstinence at month 2, 6, 12 after quit date.
Measured: 12 months
Number of cigarettes smoked per day
Mean number of cigarettes smoked per day among participants still smoking at 12 months.
Measured: 12 months
Fagerstrom Test of Nicotine Dependence (FTND) scores
The FTND is a validated, 6-item self-report instrument that evaluates the intensity of physical addiction to nicotine. The scores will be assessed at month 2, 6, 12 after quit date.Three items are rated yes/no (0/1), and the other three items are rated on a scale from 0-3. Items are summed to yield a total score of 0-10, with higher scores reflecting greater nicotine dependence. This outcome variable will be reported as the difference in FTND total score between the intervention condition and the control condition.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start28 Jun 2023
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
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, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940987
- Sponsor's protocol ID
- START
- Status last verified
- Mar 2025
- First submitted
- 15 Jun 2023
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis ：a Prospective Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05940987
- Acronym / sponsor ID
- START
- Conditions
- Pancreatitis, Chronic
- Keywords
- Smoking Cessation, Phone-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 12 Jul 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.
This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their smoking cessation rate.
Detailed description
Chronic pancreatitis（CP） is a chronically progressive disease characterized by pancreatic fibrosis and inflammation, and its basic pathological features include chronic inflammatory damage to the pancreatic parenchyma, interstitial fibrosis, pancreatic parenchymal calcification, pancreatic duct dilation, and pancreatic duct stones.
Environmental factors such as alcoholism，smoking and genetic factors are the main causative factors of CP. Clinical studies have found that smoking can not only accelerate the course of CP, but also increase the risk of CP-related complications. Some scholars believe that smoking cessation may be a potential way to prevent the progression of CP and improve the prognosis of CP. Although there is no evidence to verify whether smoking cessation will improve the clinical course of CP, the latest ACG Clinical Guideline strongly recommends CP patients quit smoking.
In 2016，a prospective study of smoking cessation interventions in CP patients showed that 27 enrolled patients had a smoking cessation rate of 0% after 6 months of smoking cessation intervention, indicating that smoking cessation is a huge challenge for CP patients.
The investigators propose to conduct a randomized controlled trial to investigate the effects of telephone intervention on smoking cessation in patients with CP and explore the impact of smoking cessation on their clinical course and prognosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Phone-based smoking cessation interventionParticipants in the intervention group will receive one 20-30 minutes "5A" smoking cessation health consultation after enrollment; They will be given regular phone-based smoking cessation intervention once a week in the first month and once a month thereafter (15 times in total). Participants will be followed at 2, 6, 12 months, and cotinine urine test kits will be mailed to those who have self-reported smoking cessation at follow-up, which is used to confirm whether they have quitted smoking or not. (smoking cessation is defined as urine cotinine levels below 200 ng/mL). |
| Control Group | No intervention | –Participants in the control group will receive one 20-30 minute "5A" smoking cessation health consultation after enrollment; Phone-based smoking cessation intervention will not be regularly given after enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18 years of age and older living; 2.Patients diagnosed as chronic pancreatitis; 3.Self-reported smoking ≥ 5 cigarettes; 4.Urine cotinine levels ≥ 200 ng/mL; 5.Owning a phone; 6.Willing to provide informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Patients diagnosed as pancreatic cancer within 2 years after diagnosing chronic pancreatitis; Patients diagnosed as groove pancreatitis or autoimmune pancreatitis;
- Pregnant or lactating women;
- Patients with life expectancy ≤ 12 months;
- Comorbidities such as Alzheimer's disease, end-stage cancer, HIV, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease, uncompensated cirrhosis, renal failure;
- Smoking e-cigarettes or other forms of non-burning tobacco.
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 |
|---|---|---|
| Phone-based smoking cessation interventionParticipants who allocate to the intervention group will receive regular phone-based smoking cessation intervention by professional team. | Behavioural | Intervention Group |
Primary outcome
Biochemically Validated of 7-day Point Abstinence
Time frame: 12 months
The primary outcome will be biochemical validation of Self-reported 7-day point-prevalence abstinence at month 12 after quit date.
3 secondary outcomes
Self-reported 7-day Point Abstinence
Time frame: 12 months
Number of cigarettes smoked per day
Time frame: 12 months
Fagerstrom Test of Nicotine Dependence (FTND) scores
Time frame: 12 months
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 20 Oct 2026.
- 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, M.D. 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?
A study testing Phone-based smoking cessation intervention in people with Pancreatitis, Chronic, 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 6 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 20 Oct 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 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?
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?
Biochemically Validated of 7-day Point Abstinence (time frame: 12 months). 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 20 Oct 2026.