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

NCT07123649 | Recruiting Phase 2

• 2 other identifiers: 25-1221R01AG089237-01
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast Cancer Survivor; Breast Cancer Survivorship

Outcome Measures

Primary Outcomes (1)

• Mammography Rate

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

  Assessed at 2 years post-enrollment.

Secondary Outcomes (3)

• Mammography Count

  Assessed at 2 years post-enrollment.

• Participant Knowledge Score

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

• Participant Decisional Quality Score

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

Study Arms (2)

Shared-Decision Making Toolkit

EXPERIMENTAL

Enrolled 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

Behavioral: Shared Decision-Making Toolkit

Usual Care

NO INTERVENTION

Enrolled 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

Interventions

Shared Decision-Making Toolkit BEHAVIORAL

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.

Also known as: SDM Toolkit

Shared-Decision Making Toolkit

Eligibility Criteria

• Age: 80 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rachel Freedman, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Freedman, MD, MPH

CONTACT

617-632-4587; Rachel_freedman@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomized to having educational material or not.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized at the clinician level in a 1:1 fashion, stratified by site

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): September 11, 2027
• Study Completion (Estimated): September 11, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)