Building a Comprehensive Tobacco Cessation Program for Cancer Patients and Survivors: "A Breath of Fresh Air"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Acceptability: Participant satisfaction
Study Overview
Brief Summary
The purpose of this research study is to learn how best to incorporate tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers.
Detailed Description
The goal of this study is to generate knowledge regarding the feasibility and acceptability of integrating tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers. The evidence base regarding tobacco treatment is solid: pharmacology (nicotine replacement therapy (and/or), bupropion, or varenicline) in combination with behavioral counseling yields the best results with respect to cessation rates. What remains unclear is how best to offer and implement this comprehensive treatment in the context of a cancer center-especially in a patient population facing social determinants of health that may not be in favor of tobacco cessation. Thus, in this study, the investigators are offering the "gold standard" tobacco treatment and assessing feasibility and acceptability of these procedures in order to inform future efforts to optimize treatment delivery for this unique population and setting. The intervention for this protocol was approved for standard of care use.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with study procedures and availability for the duration of the study
- •Have a documented history of cancer of any type, whether active or in remission
- •Identify as a current or recently-quit tobacco user
Exclusion Criteria
- •Not a VCUHealth patient
- •Non English-speaking
Arms & Interventions
Behavioral Counseling for Tobacco Cessation
Behavioral counseling for tobacco cessation consists of psychoeducation in combination with evidence-based behavior change techniques including stimulus control, self-monitoring, goal-setting, implementation planning, and problem-solving. Specific content topics include the harms of smoking/benefits of quitting, coping with cravings and withdrawal, setting a quit date, managing social influences, and relapse prevention.
Intervention: Behavioral counseling for tobacco cessation (Behavioral)
Observational Arm
Both the behavioral intervention and pharmacotherapy will be conducted as a routine clinical activities (treatment as usual)-not as research activities
Outcomes
Primary Outcomes
Acceptability: Participant satisfaction
Time Frame: Week 24
Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint.
Feasibility: Barriers to participation
Time Frame: At recruitment visit
Reasons for refusal will be collected for eligible individuals who do not enroll in the study.
Acceptability: Nicotine replacement therapy adherence
Time Frame: Week 24
Self-reported adherence to nicotine replacement therapy and/or varenicline or bupropion will be assessed at each follow-up timepoint. In addition, data re: tobacco cessation medication visits will be extracted from participants' EMR (e.g., number of visits, prescriptions written).
Feasibility: Consent rate
Time Frame: At enrollment visit
The number of individuals who consented to participate compared to the number of individuals approached for study participation.
Acceptability: Behavioral counseling attendance
Time Frame: 12 weeks
Participant attendance at scheduled group or 1:1 behavioral intervention sessions
Secondary Outcomes
No secondary outcomes reported