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NCT Number: NCT06461650

Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32608, United States

Location status: Recruiting

Location contact

Christiana Shaw, MD

PRINCIPAL_INVESTIGATOR

Nicole Davila

CONTACT

[email protected]

352-273-7345

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acceptability

    Time frame: 10-30 weeks

    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.

  2. Preliminary efficacy

    Time frame: 10-30 weeks

    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.

  3. Short-term impact on nicotine cessation

    Time frame: 10 days prior to surgery

    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.

  4. Long-term impact on nicotine cessation

    Time frame: 12 months postoperatively

    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.

  5. 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)

    Determine patient engagement, as measured by number of program sessions completed and which program sessions were completed.

  6. Surgical procedure

    Time frame: At surgery

    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.

Study contacts

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

Nicole Davila

CONTACT

[email protected]

(352) 273-8429

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2024
Registry last updated
Jun 25, 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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