Tobacco Use CessationNCT05805722
Comprehensive Tobacco Cessation for Cancer Patients and Survivors
A study testing Behavioral counseling for tobacco cessation in people with Tobacco Use Cessation and Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation, Cancer
- What is being tested?
- Behavioral counseling for tobacco cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a VCUHealth patient
- Non English-speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Antonice Wall, 804-628-6430
Massey CPC Team, 804-828-1965, masseycpc@vcu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Use Cessation, Cancer
- Being tested
- Behavioral counseling for tobacco cessation
- Medical subject headings
- Tobacco Use Cessation, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral counseling for tobacco cessationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Counseling for Tobacco Cessation | Experimental | 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. Receives: Behavioral: Behavioral counseling for tobacco cessation |
| Observational Arm | No intervention | Both the behavioral intervention and pharmacotherapy will be conducted as a routine clinical activities (treatment as usual)-not as research activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Consent rate
The number of individuals who consented to participate compared to the number of individuals approached for study participation.
Measured: At enrollment visit
Feasibility: Barriers to participation
Reasons for refusal will be collected for eligible individuals who do not enroll in the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24
Acceptability: Behavioral counseling attendance
Participant attendance at scheduled group or 1:1 behavioral intervention sessions
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start12 Apr 2023
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Livingstone Aduse-Poku, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805722
- Sponsor's protocol ID
- MCC-22-19970
- Other IDs
- HM20026004
- Status last verified
- Jun 2026
- First submitted
- 1 Mar 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building a Comprehensive Tobacco Cessation Program for Cancer Patients and Survivors: "A Breath of Fresh Air"
- ClinicalTrials.gov ID
- NCT05805722
- Acronym / sponsor ID
- MCC-22-19970
- Conditions
- Tobacco Use Cessation, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Counseling for Tobacco Cessation | Experimental | Behavioral: Behavioral counseling for tobacco cessationBehavioral 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. |
| Observational Arm | No intervention | –Both the behavioral intervention and pharmacotherapy will be conducted as a routine clinical activities (treatment as usual)-not as research activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not a VCUHealth patient
- Non English-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral counseling for tobacco cessationParticipants 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 | Behavioural | Behavioral Counseling for Tobacco Cessation |
Primary outcome
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.
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.
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.
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.
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.
Acceptability: Behavioral counseling attendance
Time frame: 12 weeks
Participant attendance at scheduled group or 1:1 behavioral intervention sessions
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Livingstone Aduse-Poku, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral counseling for tobacco cessation in people with Tobacco Use Cessation and Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonice Wall (804-827-2357, walla2@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Consent rate (time frame: At enrollment visit). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.