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

NCT ID: NCT05940987

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-28
• Study Completion Date: 2025-02-25

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.

Conditions

Pancreatitis, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Phone-based smoking cessation intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phone-based smoking cessation intervention

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaoshen Li

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang-hao Hu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hostipal

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

START

Identifier Type: -

Identifier Source: org_study_id