Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 80 Years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires, Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Study procedures include questionnaires and option interviews with study staff."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
The I-MAMMO study tests a toolkit that helps women age 80 and older who have had breast cancer decide whether to keep getting mammograms. Mammograms are breast X-rays, and the toolkit supports making this choice with a clinician.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 80 or older who have had stage 0–III breast cancer, including certain early cancers that have not spread.
- Have no breast cancer that has come back. Separate, new breast cancers are allowed if all other study rules are met.
- Have at least one breast and had a mammogram within the past 24 months.
- It has been at least 12 months since the last surgery on the breast with cancer.
- Are not getting cancer treatment other than hormone therapy or medicines called CDK 4/6 inhibitors.
- Can and will take surveys, and get some cancer follow-up care at a study site.
- The latest mammogram does not call for more tests or an early repeat scan. Past concerns must be confirmed as not cancer. People waiting for results may enroll, but will not take surveys or be included in the study results if more testing is needed.
- Clinicians may join if they are active doctors, nurse practitioners, or physician assistants at a study site, care for at least one breast cancer survivor age 80 or older, and can read, speak, and write English.
Who can't join
- Cannot give informed consent, meaning they cannot agree to join after learning about the study.
- Were assigned male sex at birth, are pregnant, are younger than 80, or are in prison.
- Have breast changes or recent scan results that need more testing when the study starts.
- Have already stopped getting mammograms, based on medical records or their own report.
- Have only had atypical ductal hyperplasia (ADH) or non-pleomorphic lobular carcinoma in situ (LCIS), which are certain abnormal breast cell changes.
- Have a mental health condition that would make it hard to follow study requirements.
- Have breast cancer that has spread to distant parts of the body, or are in hospice care.
- Their clinician is not willing to take part.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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
Study sites (1)
MA
- Dana-Farber Cancer Institute · Boston, MA 02115Rachel Freedman, MD, MPH · Study contact · 617-632-4587 · Rachel_freedman@dfci.harvard.eduRachel Freedman, MD, MPH · Principal investigatorMore trials in Boston