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

Naval Military Medical University

Status: Completed

Conditions: Pancreatitis, Chronic

Treatments: Behavioral: Phone-based smoking cessation intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05940987

START

Details and patient eligibility

About

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

Full 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.

Enrollment: 382 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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382 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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).

Treatment:

Behavioral: Phone-based smoking cessation intervention

Control Group

No Intervention group

Description:

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.