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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Rachel Freedman, MD, MPH
Rachel_freedman@dfci.harvard.edu
617-632-4587
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 364
Treatments
Experimental: 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
No_intervention: 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
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov