Comprehensive Tobacco Cessation for Cancer Patients and Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Building a Comprehensive Tobacco Cessation Program for Cancer Patients and Survivors: A Breath of Fresh Air

Conditions
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Tobacco Use Cessation, Cancer

Intervention / Treatment
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* Behavioral: Behavioral counseling for tobacco cessation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Counseling for Tobacco Cessation<br>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. | Behavioral: Behavioral counseling for tobacco cessation<br>* Participants can choose to receive behavioral counseling in group v. individual format: Group Sessions: Participants will be offered the opportunity to attend 6 weekly 60-90 minute sessions Individual Sessions: Participants will be offered the opportunity to attend up to 12 30-45 minute sessions on a schedule mutually agreed upon between interventionist and participant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Consent rate | The number of individuals who consented to participate compared to the number of individuals approached for study participation. | At enrollment visit | 
| Feasibility: Barriers to participation | Reasons for refusal will be collected for eligible individuals who do not enroll in the study. | At recruitment visit | 
| Acceptability: Participant satisfaction | 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. | Week 6 | 
| Acceptability: Participant satisfaction | 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. | Week 12 | 
| Acceptability: Participant satisfaction | 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. | Week 24 | 
| Acceptability: Behavioral counseling attendance | Participant attendance at scheduled group or 1:1 behavioral intervention sessions | 12 weeks | 
| Acceptability: Nicotine replacement therapy adherence | 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). | Week 6 | 
| Acceptability: Nicotine replacement therapy adherence | 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). | Week 12 | 
| Acceptability: Nicotine replacement therapy adherence | 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). | Week 24 |