End Nicotine Dependence Clinic

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Early Phase 1

Conditions: Smoking Cessation

Treatments: Behavioral: Phone Counseling; Behavioral: Texting support; Behavioral: Group Counseling; Behavioral: Individual Counseling; Drug: Nicotine Replacement Therapy; Behavioral: Video Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03290430

CASE3Z17

Details and patient eligibility

About

The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.

Full description

Objective 1: To examine the feasibility of conducting an evidence-based, cognitive behavioral therapy (CBT) for tobacco cessation delivered in multiple formats. Participants will have the opportunity to receive a CBT-based tobacco intervention delivered several possible formats (face-to-face, telephone, video-counseling) based on availability and participant preferences. Study participants will be exposed to cognitive-behavioral cessation and relapse prevention strategies, and discuss barriers to cessation, previous quit attempts, risky situations, and benefits observed after quitting. Participants may also complete exercises designed to assist cessation attempts (e.g., mental and behavioral coping skills, cognitive reframing exercise, health benefits of cessation; and no-smoking behavioral contracts). As supplemental treatment, participants may have the option to receive up to 8 weeks of nicotine replacement therapy and text-messaging support.

Objective 2: To examine the rates of smoking abstinence across intervention formats. Investigators will attempt to follow-up with participants for a 6-months after program completion. Investigators will assess point prevalence abstinence for each intervention delivery method.

Objective 3: To assess individual difference variables that influence outcomes. Investigators will examine individual-difference predictors of outcomes, such as readiness to quit, social support, distress, and environmental factors.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Current smokers who would like help quitting (≥ 5 cigarettes per day and/or have a breath carbon monoxide (CO) reading of ≥ 8 ppm)
• Able to speak and read English
• Able to engage using at least one of the intervention formats.

Exclusion criteria

• Enrollment in another cessation program
• Do not speak and read English
• Do not have access to at least one intervention format
• Have contraindications for NRT
• Do not have contact information (e.g., address, telephone number)
• Are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse)
• They endorse active addiction to another substance (e.g., illicit drugs or alcohol).
• People who self-report having a severe mental illness

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

Group Counseling

Experimental group

Description:

Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 1-2 hours. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.

Treatment:

Behavioral: Group Counseling

Drug: Nicotine Replacement Therapy

Behavioral: Texting support

Individual Counseling

Experimental group

Description:

Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 30-45 minutes. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Texting support

Behavioral: Individual Counseling

Telephone Counseling

Experimental group

Description:

Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 phone calls over 4 week, each lasting between 30-45 minutes. During these phone calls, participants will learn about how to quit smoking by changing habits. Sessions may be audio taped. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Texting support

Behavioral: Phone Counseling

Video Counseling

Experimental group

Description:

Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 video calls over 4 week, each lasting between 30-45 minutes. During these video calls, participants will learn about how to quit smoking by changing habits. Sessions may be recorded. The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Video Counseling

Behavioral: Texting support