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

NCT05940987 | Completed DMC

• 1 other identifier: START
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatitis, Chronic

Keywords

Smoking Cessation; Phone-based intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Self-reported 7-day Point Abstinence

  12 months

• Number of cigarettes smoked per day

  12 months

• Fagerstrom Test of Nicotine Dependence (FTND) scores

  12 months

Other Outcomes (2)

• Reduction in Tobacco Consumption

  12 months

• Times of hospitalizations

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Phone-based smoking cessation intervention BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed as pancreatic cancer within 2 years after diagnosing chronic pancreatitis; Patients diagnosed as groove pancreatitis or autoimmune pancreatitis;
• Pregnant or lactating women;
• Patients with life expectancy ≤ 12 months;
• 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;
• Smoking e-cigarettes or other forms of non-burning tobacco.
• Patients refused to participate.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hostipal

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Smoking Cessation

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Liang-hao Hu, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 12, 2023
• Study Start: June 28, 2023
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)