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Breast CancerPhase 2I-MAMMONCT07123649

Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study

A Phase 2 study testing Shared Decision-Making Toolkit in people with Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 80 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Shared Decision-Making Toolkit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
1 siteUnited States
Study dates
11 Sep 2025to 11 Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • Women only
  • Healthy volunteers accepted
  • Older adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Freedman, MD, MPH contact

617-632-4587

Rachel_freedman@dfci.harvard.edu

United States1 site, 1 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

    Rachel Freedman, MD, MPH, 617-632-4587, Rachel_freedman@dfci.harvard.edu

    Rachel Freedman, MD, MPH

    Recruiting

Other trials in United States

About this study

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.

Read the detailed 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.

A participant will be placed into one of two groups: Group A: Usual Care vs. Group B: SDM Toolkit according to the randomized placement of the assigned study clinician.

Study procedures include questionnaires and option interviews with study staff.

Participation in this research study is expected to last about 2 years.

It is expected about 52 clinicians and 312 participants will take part in this research study.

The National Institute on Aging is providing funding for this research study

Conditions
Breast Cancer
Being tested
Shared Decision-Making Toolkit
Keywords
Breast Cancer, Breast Cancer Survivor, Breast Cancer Survivorship
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shared Decision-Making ToolkitBehavioural

    Also called SDM 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.

Study groups in NCT07123649
Study groupRoleWhat they receive
Shared-Decision Making ToolkitExperimentalEnrolled participants will complete: * Year 1 standard of care visit with clinician followed by post-visit survey * Optional semi-structured interview with study staff * Year 2 standard of care visit with clinician followed by post-visit survey * Optional semi-structured interview with study staff * End of study survey
Receives: Behavioral: Shared Decision-Making Toolkit
Usual CareNo interventionEnrolled participants will continue with standard care practices without the SDM toolkit and will complete: * Year 1 standard of care visit with clinician followed by post-visit survey * Year 2 standard of care visit with clinician followed by post-visit survey * Optional semi-structured interview with study staff

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mammography Rate

    Mammography Rate is defined as the proportion of participants that undergo mammography by 2 years post-enrollment.

    Measured: Assessed at 2 years post-enrollment.

Secondary outcomes (3)

  1. Mammography Count

    Mammography Count is defined as the count of all mammograms each participant underwent during study follow-up.

    Measured: Assessed at 2 years post-enrollment.

  2. Participant Knowledge Score

    Participant Knowledge Score will be defined as the proportion of correct knowledge questions (range: 0 to 1).

    Measured: Annually through 2 years of follow-up post-enrollment.

  3. Participant Decisional Quality Score

    Participant Decisional Quality Score will be defined as the sum of response scores (range of 0-4), with each individual response scored 0 or 1. Higher scores indicate higher decisional quality.

    Measured: Annually through 2 years of follow-up post-enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start11 Sep 2025
  3. Primary completion11 Sep 2027 (estimated)
  4. Study completion11 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized at the clinician level in a 1:1 fashion, stratified by site
Masking
None (open label)
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07123649
Sponsor's protocol ID
25-122
Other IDs
1R01AG089237-01
Acronym
I-MAMMO
Status last verified
Apr 2026
First submitted
8 Aug 2025
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Shared Decision-Making Toolkit in people with Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Freedman, MD, MPH (617-632-4587, Rachel_freedman@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mammography Rate (time frame: Assessed at 2 years post-enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07123649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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