Individualized surveillance mammography for older breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 study assigns clinicians (and their patients) to either usual care or a shared decision-making (SDM) toolkit designed for breast cancer survivors aged 80 and above. Participants complete questionnaires and may take part in optional interviews, with outcomes compared between the SDM and usual care groups. The study plans to enroll about 312 participants and 52 clinicians and follows participants for roughly two years. Funding is provided by the National Institute on Aging and the study is conducted at Dana-Farber Cancer Institute.

Why it matters

Who can join: the full rules

Participant 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

  -≥ 12 months since most recent breast surgery to affected breast (e.g., breast reduction surgery on an unaffected breast within 12 months is ok)
* 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

  * If a patient required diagnostic breast testing in the past or at the time of the most recent mammogram AND the results were resolved to benign findings with no additional diagnostics recommended, they are eligible.
  * If a patient's most recent mammogram result isn't yet available at the time of approach or study consent, the patient is eligible to proceed with consent and enrollment. If this mammogram then abnormal or requires additional imaging, that patient will not be included in the study analyses or surveys. This patient will be replaced.

Participant 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

Clinician Inclusion Criteria:

* Must be an active clinician (MD, NP, or PA) at a participating institution
* Sees at least one breast-cancer survivor aged ≥ 80
* Clinician must be able to read, speak, and write in English

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Rachel Freedman, MD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Rachel Freedman, MD, MPH
• Email: Rachel_freedman@dfci.harvard.edu
• Phone: 617-632-4587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.