Breast CancerNCT06461650
Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction
A study testing Nicotine cessation program in people with Breast Cancer, run by University of Florida at 1 site in United States.
Trial summary
Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nicotine cessation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2024to Mar 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age and ≤ 80 years of age.
- Women who are diagnosed with Stage 0 - 3 breast cancer confirmed by biopsy
- Women who have been recommended to have reconstruction at time of mastectomy or oncoplastics at time of lumpectomy
- Participants who actively use nicotine products defined as any self-reported nicotine use within the past month
- Participant agrees to comply with all the study-related procedures.
Who cannot join
- Patients not eligible for reconstruction or oncoplastics for other reasons including BMI>35 or inflammatory breast cancer or based on surgeon discretion.
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Patients unable to complete the sessions because of language, travel or technology barriers
- Patients already actively participating in another cessation program
- Patients who are pregnant.
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
University of Florida
Gainesville, Florida, 32608
Nicole Davila, 352-273-7345, ndavila@UFL.EDU
Christiana Shaw, MD
About this study
Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications. Nicotine cessation is rarely addressed in breast cancer patients at the time of diagnosis and may be a missed opportunity to optimize patient outcomes. Patients that use nicotine products are not offered reconstruction at time of mastectomy or oncoplastics at the time of lumpectomy, which can be emotionally distressing in women with breast cancer. Reconstruction could be an additional motivating factor in nicotine cessation success.
This study aims to evaluate the feasibility of a nicotine cessation program designed by Area Health Education Center (AHEC) in the target population. The study is designed to test the acceptability, and preliminary efficacy of a formal nicotine cessation program in women actively using nicotine products with breast cancer recommended for reconstructive or oncoplastics surgery.
- Conditions
- Breast Cancer
- Being tested
- Nicotine cessation program
- Keywords
- breast cancer, nicotine cessation, mastectomy, reconstruction, smokers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine cessation programBehavioural
Participants will complete up to 4 sessions of a nicotine cessation program over either 12-24 weeks if receiving neoadjuvant therapy (i.e. chemotherapy or hormonal/endocrine therapy) prior to surgery or over 4-6 weeks if not receiving neoadjuvant therapy prior to surgery. Each session will be 30-60 minutes long. Participants receiving neoadjuvant therapy will also be eligible for nicotine replacement therapy; however, it must be stopped 6 weeks before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine cessation program | Experimental | Not described Receives: Behavioral: Nicotine cessation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Determine the feasibility of the nicotine cessation program used in this study, as measured by subject participation in at least one program session after study enrollment.
Measured: 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)
Secondary outcomes (6)
Acceptability
Determine the acceptability of the nicotine cessation program used in this study, as measured by participant surveys administered at baseline, at completion of the nicotine cessation program sessions, and at 6 weeks postoperatively.
Measured: 10-30 weeks
Preliminary efficacy
Determine the preliminary efficacy of the nicotine cessation program used in this study, as measured by participant surveys administered at baseline, at completion of the nicotine cessation program sessions, and at 6 weeks postoperatively.
Measured: 10-30 weeks
Short-term impact on nicotine cessation
Determine the short-term impact on nicotine cessation of the nicotine cessation program used in this study, as measured by cotinine levels prior to surgery.
Measured: 10 days prior to surgery
Long-term impact on nicotine cessation
Determine the long-term impact on nicotine cessation of the nicotine cessation program used in this study, as measured by a participant survey administered 12 months postoperatively.
Measured: 12 months postoperatively
Patient engagement
Determine patient engagement, as measured by number of program sessions completed and which program sessions were completed.
Measured: 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)
Surgical procedure
Determine the surgical procedure each participant underwent following completion of the nicotine cessation program, including if the participant had either reconstruction or oncoplastics at the time of this surgery.
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start14 Nov 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christiana Shaw, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461650
- Sponsor's protocol ID
- UF-BRE-013
- Other IDs
- IRB202401102
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction
- ClinicalTrials.gov ID
- NCT06461650
- Acronym / sponsor ID
- UF-BRE-013
- Conditions
- Breast Cancer
- Keywords
- breast cancer, nicotine cessation, mastectomy, reconstruction, smokers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 17 Jun 2024 (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.
Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications. Nicotine cessation is rarely addressed in breast cancer patients at the time of diagnosis and may be a missed opportunity to optimize patient outcomes. Patients that use nicotine products are not offered reconstruction at time of mastectomy or oncoplastics at the time of lumpectomy, which can be emotionally distressing in women with breast cancer. Reconstruction could be an additional motivating factor in nicotine cessation success.
This study aims to evaluate the feasibility of a nicotine cessation program designed by Area Health Education Center (AHEC) in the target population. The study is designed to test the acceptability, and preliminary efficacy of a formal nicotine cessation program in women actively using nicotine products with breast cancer recommended for reconstructive or oncoplastics surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine cessation program | Experimental | Behavioral: Nicotine cessation program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 years of age and ≤ 80 years of age.
- Women who are diagnosed with Stage 0 - 3 breast cancer confirmed by biopsy
- Women who have been recommended to have reconstruction at time of mastectomy or oncoplastics at time of lumpectomy
- Participants who actively use nicotine products defined as any self-reported nicotine use within the past month
- Participant agrees to comply with all the study-related procedures.
Key exclusion criteria (5 listed)
- Patients not eligible for reconstruction or oncoplastics for other reasons including BMI>35 or inflammatory breast cancer or based on surgeon discretion.
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Patients unable to complete the sessions because of language, travel or technology barriers
- Patients already actively participating in another cessation program
- Patients who are pregnant.
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 |
|---|---|---|
| Nicotine cessation programParticipants will complete up to 4 sessions of a nicotine cessation program over either 12-24 weeks if receiving neoadjuvant therapy (i.e. chemotherapy or hormonal/endocrine therapy) prior to surgery or over 4-6 weeks if not receiving neoadjuvant therapy prior to surgery. Each session will be 30-60 minutes long. Participants receiving neoadjuvant therapy will also be eligible for nicotine replacement therapy; however, it must be stopped 6 weeks before surgery. | Behavioural | Nicotine cessation program |
Primary outcome
Feasibility
Time frame: 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)
Determine the feasibility of the nicotine cessation program used in this study, as measured by subject participation in at least one program session after study enrollment.
6 secondary outcomes
Acceptability
Time frame: 10-30 weeks
Preliminary efficacy
Time frame: 10-30 weeks
Short-term impact on nicotine cessation
Time frame: 10 days prior to surgery
Long-term impact on nicotine cessation
Time frame: 12 months postoperatively
Patient engagement
Time frame: 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)
Surgical procedure
Time frame: At surgery
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 25 Jun 2026.
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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.
Christiana Shaw, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine cessation program in people with Breast Cancer, run by University of Florida 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 5 inclusion and 5 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 25 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 Nicole Davila ((352) 273-8429, ndavila@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)). 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 25 Jun 2026.