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Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a program to help women quit nicotine is practical, acceptable, and may help them quit. It is for women with breast cancer who use nicotine and have been advised to have surgery to rebuild or reshape the breast during cancer surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women ages 18 to 80.
  • Have stage 0 to 3 breast cancer confirmed by a biopsy, a test of a tissue sample.
  • Have been advised to have breast rebuilding during surgery to remove the breast, or breast reshaping during surgery to remove the cancer lump.
  • Report using any nicotine product within the past month.
  • Agree to follow all study steps.

Who can't join

  • Cannot have breast rebuilding or reshaping for other reasons, such as a body mass index (BMI, a measure based on height and weight) over 35, inflammatory breast cancer, or the surgeon's decision.
  • Are in prison, held against your will, or required to stay in a facility for mental or physical health treatment.
  • Cannot complete the sessions because of language, travel, or technology barriers.
  • Are already taking part in another program to quit nicotine.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

FL