Clinical Trial 24036

• Overview

  Study Title:

  Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors: The I-MAMMO Study

  Summary:

  This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography.

  Objective:

  AIM 1. Determine the effect of the SDM toolkit on utilization of surveillance mammography and clinical outcomes in breast cancer survivors less than or equal to 80 years of age. AIM 2. Determine effects of the SDM toolkit on mammography knowledge and on SDM between older breast cancer survivors and clinicians. AIM 3. Guided by CFIR8, assess multi-level facilitators and barriers to implementing the SDM toolkit and reducing mammography.

• Inclusion Criteria

  Key Inclusion Criteria:
  • Women aged ≥ 80 years at the time of registration
  • History of stage 0-III breast cancer (Of note: ductal carcinoma in situ [DCIS], pleomorphic lobular carcinoma in situ [because it is typically treated like DCIS], or invasive breast cancer of any subtype are all eligible)
  • No history of a recurrent breast cancer (i.e., a breast cancer that is deemed metastatic or a locoregional recurrence of a prior cancer per clinician judgement rather than a new primary breast cancer). If a person has been diagnosed with multiple distinct breast cancers over time (e.g., history of left and right breast cancer), they are eligible as long as they meet other requirements for time since surgery, etc.
  • Has at least one intact breast
  • Has had mammogram screening/surveillance within the last 24 months
  • No active cancer-directed therapy other than hormonal therapy and/or CDK 4/6 inhibitor therapy
  • Ability and willingness to take surveys
  • Receiving at least some of their oncology follow-up care at a participating site
  • Most recent mammogram report for the potential participant did not recommend additional diagnostic work-up or close interval follow-up imaging

• Exclusion Criteria

  Key Exclusion Criteria:
  • Inability to provide informed consent
  • Assigned male sex at birth
  • Breast or recent imaging findings requiring diagnostic testing at baseline
  • Prior discontinuation of mammography by electronic medical record (EMR) review or patient report
  • Prior atypical ductal hyperplasia (ADH) or non-pleomorphic LCIS only
  • Psychiatric illness situations that would limit compliance with study requirements
  • Those with metastatic breast cancer
  • Those in hospice care
  • Those whose clinician is not willing to participate
  • Pregnant women, young patients, and those in prison will not be eligible for enrollment given the study design and aims supporting study in a different population focused on older adults

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