Hepatitis C, Smoking Cessation
Conditions
Brief summary
A 12-week study for patients who are being treated for Hepatitis C and would like to quit smoking. During the 12 weeks of Hepatitis C treatment, the research team will have counseling sessions with the participants to discuss challenges related to Hepatitis C and smoking.
Detailed description
A 12-week smoking cessation intervention addressing concurrently HCV and smoking cessation The Standard of care for HCV is 12 weeks of oral medication with 3 in-person provider/laboratory visits throughout. This study utilizes both in-person and phone counseling and health education sessions. Each session will address a different topic related to HCV, smoking, and how both smoking and HCV affect health and quality of life.
Interventions
BEHAVIORALCognitive Behavioral Counseling
The intervention consisted of 12 weeks of HCV treatment combined with smoking cessation pharmacotherapy and brief behavioral counseling conducted by a LMSW. The brief behavioral counseling consisted of cognitive behaioral components and was provided by phone and in-person. The intervention followed these 5 phases: increase motivation to quit smoking, quit attempt, maintain short-term abstinence, and lapse and relapse prevention.
Sponsors
Prisma Health-Upstate
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
We conducted a single-arm pilot study in order to test the feasibility and preliminary efficacy of a smoking cessation intervention for people with HCV while they received standard of care treatment: antiviral medication and provider/laboratory visits.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years old) * Current HCV infection (HCV RNA+) * Current cigarette smoking * Patients in contemplation / preparation stage of change
Exclusion criteria
* Inability to speak/read English, as materials will be provided in English * Current suicidal ideation as determined by the PHQ-9, requiring a greater level of clinical care * Severe medical or psychiatric disability that prevents participant from ability to comprehend or consent to study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of cigarettes smoked per day (CPD) | baseline (week 0) to end of treatment (week 12) | We will track the number of cigarettes the participant smokes per day at each weekly visit, then compare the CPD at baseline during week 0 to the end of treatment at week 12. |
| Change in Fagerstrom Test for Nicotine Dependence (FTND) score | baseline (week 0) to end of treatment (week 12) | We will calculate the participant's FTND score at the baseline visit during week 0 and compare it to their FTND score at the end of treatment visit during week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptomology using Patient Health Questionnaire (PHQ-9) score | baseline (week 0) to end of treatment (week 12) | We will calculate the participant's PHQ-9 score at the baseline visit during week 0 and compare it to their PHQ-9 score at the end of treatment visit during week 12. |
| Number of quit attempts | baseline (week 0) to end of treatment (week 12) | We will measure the number of quit attempts made throughout the intervention from baseline to end of treatment. |
Countries
United States
Outcome results
None listed