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NCT Number: NCT05805722

Comprehensive Tobacco Cessation for Cancer Patients and Survivors

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.

Recruiting

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Key information

Conditions

Tobacco Use Cessation Behavior Cancer Health Behavior Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location status: Recruiting

Location contact

Antonice Wall

CONTACT

804-628-6430

Livingstone Aduse-Poku, Ph.D

PRINCIPAL_INVESTIGATOR

Massey CPC Team

CONTACT

[email protected]

804-828-1965

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral counseling for tobacco cessation

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. Acceptability: Participant satisfaction

    Time frame: Week 6

    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.

  4. Acceptability: Participant satisfaction

    Time frame: Week 12

    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.

  5. 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.

  6. Acceptability: Behavioral counseling attendance

    Time frame: 12 weeks

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

  7. Acceptability: Nicotine replacement therapy adherence

    Time frame: Week 6

    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).

  8. Acceptability: Nicotine replacement therapy adherence

    Time frame: Week 12

    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).

  9. 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).

Other outcomes

  1. Change in tobacco use

    Time frame: Baseline to Week 12

    Self-reported change in number of cigarettes smoked

  2. Change in tobacco use

    Time frame: Baseline to Week 24

    Self-reported change in number of cigarettes smoked

Study contacts

Contact information is provided by the study sponsor or research team.

Antonice Wall

CONTACT

[email protected]

804-827-2357

Massey CPCTeam

CONTACT

[email protected]

804-828-1965

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Apr 10, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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