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

NCT ID: NCT05805722Sponsor: Virginia Commonwealth UniversityLast updated: 2025-06-19

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.

Arms & interventions

  • BehavioralBehavioral 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

Outcome measures

Primary

  • Feasibility: Consent rate

    The number of individuals who consented to participate compared to the number of individuals approached for study participation.

    Time frame: At enrollment visit

  • Feasibility: Barriers to participation

    Reasons for refusal will be collected for eligible individuals who do not enroll in the study.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Week 24

  • Acceptability: Behavioral counseling attendance

    Participant attendance at scheduled group or 1:1 behavioral intervention sessions

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: Week 24

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (1)

Virginia Commonwealth University

Richmond, Virginia, 23298

Recruiting
Antonice Wall · Contact
Massey CPC Team · Contact
Livingstone Aduse-Poku, Ph.D · Principal Investigator