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

NCT ID: NCT07123649

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Shared-Decision Making Toolkit

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

Group Type: EXPERIMENTAL

Shared Decision-Making Toolkit

Intervention Type: 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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Shared Decision-Making 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SDM Toolkit

Eligibility Criteria

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.

• 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

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Rachel Freedman, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Freedman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Rachel Freedman, MD, MPH

Role: CONTACT

Rachel_freedman@dfci.harvard.edu

617-632-4587

Facility Contacts

Rachel Freedman, MD, MPH

Role: primary

Rachel_freedman@dfci.harvard.edu

617-632-4587

Other Identifiers

1R01AG089237-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-122

Identifier Type: -

Identifier Source: org_study_id