No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
80 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Health Services Research
Participants needed
364 (estimated)
Sponsor
Dana-Farber Cancer Institute · Other
Who this trial is looking for
This trial is looking for older women aged 80 and above who have been treated for breast cancer. Participants will help evaluate a toolkit designed to support them in making informed decisions about their mammogram screenings.
Are You a Good Fit for This Trial?
Rules you outPregnancyYoung patientsPrison population
You may be able to join if
I am 80 years old or older.
I have a history of stage 0-III breast cancer.
I have no current breast cancer or recent breast cancer recurrence.
I have at least one intact breast.
I have had a mammogram in the last 24 months.
I have had at least 12 months since my most recent breast surgery.
I can take surveys.
I receive some of my oncology care at a participating site.
You may not be able to join if
I cannot provide informed consent.
I was assigned male at birth.
I have breast imaging findings that need further testing.
I have previously stopped getting mammograms.
I have a history of atypical ductal hyperplasia or non-pleomorphic LCIS.
I have metastatic breast cancer.
I am in hospice care.
My clinician is not willing to participate.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
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 a…
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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