NCT07123649 · Dana-Farber Cancer Institute
Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study
(I-MAMMO)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations