RECRUITING

Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction

Quick Facts

Study Start:2024-11-14
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06461650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ≥ 18 years of age and ≤ 80 years of age.
  2. * Women who are diagnosed with Stage 0 - 3 breast cancer confirmed by biopsy
  3. * Women who have been recommended to have reconstruction at time of mastectomy or oncoplastics at time of lumpectomy
  4. * Participants who actively use nicotine products defined as any self-reported nicotine use within the past month
  5. * Participant agrees to comply with all the study-related procedures.
  1. * Patients not eligible for reconstruction or oncoplastics for other reasons including BMI\>35 or inflammatory breast cancer or based on surgeon discretion.
  2. * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
  3. * Patients unable to complete the sessions because of language, travel or technology barriers
  4. * Patients already actively participating in another cessation program
  5. * Patients who are pregnant.

Contacts and Locations

Study Contact

Judy Walsh
CONTACT
(352) 294-8615
PMO@cancer.ufl.edu

Principal Investigator

Jennifer Fieber, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32608
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Jennifer Fieber, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-14
Study Completion Date2029-03

Study Record Updates

Study Start Date2024-11-14
Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • nicotine cessation
  • mastectomy
  • reconstruction
  • smokers

Additional Relevant MeSH Terms

  • Breast Cancer