Comprehensive Tobacco Cessation for Cancer Patients and Survivors

Not Applicable

Active, not recruiting

• Conditions: Cancer; Tobacco Use Cessation
• Interventions: Behavioral: Behavioral counseling for tobacco cessation

• Registration Number: NCT05805722
• Lead Sponsor: Virginia Commonwealth University

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 Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-10
• Study Start: 2023-04-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Counseling for Tobacco Cessation	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.

Primary Outcome Measures

Name	Time	Method
Acceptability: Participant satisfaction	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	At recruitment visit	Reasons for refusal will be collected for eligible individuals who do not enroll in the study.
Acceptability: Nicotine replacement therapy adherence	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	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	12 weeks	Participant attendance at scheduled group or 1:1 behavioral intervention sessions

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States