New toolkit aims to take the guesswork out of mammograms for women over 80
NCT ID NCT07123649
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a decision-making toolkit for women aged 80 and older who have had breast cancer. The toolkit provides clear information to help them and their doctors decide whether to continue yearly mammograms. Researchers will track how many mammograms participants get over two years and whether the toolkit improves their understanding of the risks and benefits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Shared Decision-Making Toolkit
- What this could lead to
- If successful, this toolkit could help older breast cancer survivors make more informed, personalized decisions about whether to continue routine mammograms.
- What could go wrong
- This is a relatively small, early-phase study focused on decision-making, not on survival or cancer outcomes. The toolkit may not change actual mammography rates or improve health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 364 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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80 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States
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