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

Pancreatitis, Chronic Clinical Trial

Official title:

Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis ：a Prospective Multicenter Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05940987
• Other study ID #: START
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: Changhai Hospital
• Contact: Liang-hao Hu, M.D.
• Phone: +86-13817593520
• Email: lianghao-hu[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their smoking cessation rate.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 382
• Est. completion date: July 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Chronic

Intervention

Behavioral:
• Phone-based smoking cessation intervention
Participants who allocate to the intervention group will receive regular phone-based smoking cessation intervention by professional team.

Locations

Country	Name	City	State
China	Changhai Hostipal	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction in Tobacco Consumption	The number of CP patients who self-reported a 50% reduction in tobacco consumption at 2, 6 and 12 months after quit date.	12 months
Other	Times of hospitalizations	The times of hospitalizations for episodes of chronic pancreatitis at 12 months after quit date.	12 months
Primary	Biochemically Validated of 7-day Point Abstinence	The primary outcome will be biochemical validation of Self-reported 7-day point-prevalence abstinence at month 2, 6, 12 after quit date.	12 months
Secondary	Self-reported 7-day Point Abstinence	Self-reported 7-day point-prevalence abstinence at month 2, 6, 12 after quit date.	12 months
Secondary	Number of cigarettes smoked per day	Mean number of cigarettes smoked per day among participants still smoking at 12 months.	12 months
Secondary	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.	12 months