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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis, Chronic
• Intervention / Treatment: Behavioral: Phone-based smoking cessation intervention

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 Type: Interventional
• Enrollment (Actual): 382
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Changhai Hostipal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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).	Behavioral: Phone-based smoking cessation intervention; Participants who allocate to the intervention group will receive regular phone-based smoking cessation intervention by professional team.
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 7-day Point Abstinence	Self-reported 7-day point-prevalence abstinence at month 2, 6, 12 after quit date.	12 months
Number of cigarettes smoked per day	Mean number of cigarettes smoked per day among participants still smoking at 12 months.	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Times of hospitalizations	The times of hospitalizations for episodes of chronic pancreatitis at 12 months after quit date.	12 months

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Liang-Hao Hu, M.D., Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Actual): February 25, 2025
• Study Completion (Actual): February 25, 2025

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: July 2, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Smoking Cessation; Phone-based intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: STart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No