RecruitingPhase 2NCT07123649
Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study
Sponsor
Dana-Farber Cancer Institute
Enrollment
364 participants
Start Date
Feb 1, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 80 Years
Inclusion Criteria15
- 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.
- 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
Exclusion Criteria10
- 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
Interventions
BEHAVIORALShared Decision-Making Toolkit
The SDM toolkit is designed to support discussions on the continuation of surveillance mammography. It provides evidence-based guidelines, communication strategies, and education materials to aid in personalized decision-making.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07123649
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