Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis.(START)

Not Applicable

Completed

• Conditions: Pancreatitis, Chronic
• Interventions: Behavioral: Phone-based smoking cessation intervention

• Registration Number: NCT05940987
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study First Submitted: 2023-06-15
• Study Start: 2023-06-28
• Study First Submitted QC: 2023-07-02
• Study First Posted: 2023-07-12
• Primary Completion: 2025-02-25
• Study Completion: 2025-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Phone-based smoking cessation intervention	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).

Primary Outcome Measures

Name	Time	Method
Biochemically Validated of 7-day Point Abstinence	12 months	The primary outcome will be biochemical validation of Self-reported 7-day point-prevalence abstinence at month 2, 6, 12 after quit date.

Secondary Outcome Measures

Name	Time	Method
Self-reported 7-day Point Abstinence	12 months	Self-reported 7-day point-prevalence abstinence at month 2, 6, 12 after quit date.
Number of cigarettes smoked per day	12 months	Mean number of cigarettes smoked per day among participants still smoking at 12 months.
Fagerstrom Test of Nicotine Dependence (FTND) scores	12 months	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.

Trial Locations

Locations (1)

Changhai Hostipal; 🇨🇳 Shanghai, Shanghai, China