Health TrialsbyHealthPanel

Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Nicotine cessation program

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Nicotine cessation programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12-24 weeks (if receiving neoadjuvant therapy prior to surgery) or 4-6 weeks (if not receiving neoadjuvant therapy prior to surgery)

Secondary outcomes

1

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.

Time frame
10-30 weeks
2

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.

Time frame
10-30 weeks
3

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.

Time frame
10 days prior to surgery
4

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.

Time frame
12 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov
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