Recruiting
Phase 2

Shared Decision-Making

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT07123649

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 70+

Healthy Volunteers: Accepted

Interventions

Shared Decision-Making Toolkit

Study Details

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

Study ID

NCT07123649

Start date

Sep 11, 2025

Status verified date

Apr, 2026

Completion date

Sep 11, 2029

Anticipated

Primary completion date

Sep 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

364 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • Mammography Rate [ Time Frame: Assessed at 2 years post-enrollment. ]

Central Contacts and Locations

Central contacts

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Rachel Freedman, MD, MPH

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Breast Cancer
  • Breast Cancer Survivor
  • Breast Cancer Survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-04-22.