Comprehensive Tobacco Cessation for Cancer Patients and Survivors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Behavioral counseling for tobacco cessation

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 Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Massey CPCTeam; Phone Number: 804-828-1965; Email: MasseyCPC@vcu.edu
• Study Contact Backup: Name: Antonice Wall; Phone Number: 804-827-2357; Email: walla2@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Massey CPC Team; Phone Number: 804-828-1965; Email: masseycpc@vcu.edu
      • Contact: Antonice Wall; Phone Number: 804-628-6430
      • Principal Investigator: Livingstone Aduse-Poku, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Behavioral counseling for tobacco cessation; 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
No Intervention: Observational Arm; Both the behavioral intervention and pharmacotherapy will be conducted as a routine clinical activities (treatment as usual)-not as research activities

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tobacco use	Self-reported change in number of cigarettes smoked	Baseline to Week 12
Change in tobacco use	Self-reported change in number of cigarettes smoked	Baseline to Week 24

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Livingstone Aduse-Poku, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MCC-22-19970; HM20026004 (Other Identifier: VCU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No