Clinical trial NCT05940987: Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis.(START)
Official title: Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis ：a Prospective Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis, Chronic
Keywords: Smoking Cessation
Phone-based intervention
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. Patients diagnosed as pancreatic cancer within 2 years after diagnosing chronic pancreatitis; Patients diagnosed as groove pancreatitis or autoimmune pancreatitis;
2. Pregnant or lactating women;
3. Patients with life expectancy ≤ 12 months;
4. 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;
5. Smoking e-cigarettes or other forms of non-burning tobacco.
6. Patients refused to participate.

Primary outcomes:
measure: Biochemically Validated of 7-day Point Abstinence
timeFrame: 12 months
Secondary outcomes:
measure: Self-reported 7-day Point Abstinence
timeFrame: 12 months
measure: Number of cigarettes smoked per day
timeFrame: 12 months
measure: Fagerstrom Test of Nicotine Dependence (FTND) scores
timeFrame: 12 months
Other outcomes:
measure: Reduction in Tobacco Consumption
timeFrame: 12 months
measure: Times of hospitalizations
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Changhai Hostipal
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Liang-hao Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: