The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-74
SponsorGeorgetown University

About this trial

The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

female

aged 18-74 years

self-identifying as Black and/or Latina

no personal history of breast cancer

Disqualifiers

aged <18 or ≥75

pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced Usual Care

    Behavioral

    Risk assessment and notification, referral to nurse practitioner (NP) at the Ralph Lauren Center (RLC)

  • Decision Support

    Behavioral

    The decision aid describes two different breast cancer screening plans: (1) annual mammography only; and (2) annual mammography plus annual breast MRI. The decision aid provides balanced information about breast MRI, including its risks, limitations, and benefits.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Enhanced Usual CareActive comparator 1 intervention
Group B: Decision SupportExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Informed decisions about breast MRI

According to the Multidimensional Measure of Informed Choice, an informed decision is made with adequate knowledge and consistent with the respondent's preferences. Thus, two groups are classified as having made an informed decision: (1) those with adequate MRI knowledge, whose preferences align with screening with mammogram + MRI, and who intend to undergo MRI; and (2) those with adequate MRI knowledge, whose preferences align with screening with mammogram only, and who do not intend to undergo MRI. The knowledge, preferences, and intentions scores collected at T1 will be used to identify informed decisions.

Time frame
1 month

Secondary outcomes

1

Decision Satisfaction

The Satisfaction With Decision (SWD) scale includes 6 items rated from "strongly disagree" (1) to "strongly agree" (5). Items are averaged to create a total score ranging from 1-5 (higher=greater satisfaction). Instructions will specify decisions about breast cancer screening.

Time frame
1 month
2

Decisional Conflict

The low-literacy version of the Decisional Conflict Scale (DCS) includes 10 items rated as "yes" (0), "unsure" (2), or "no" (4). Items are summed and transformed to create total scores ranging from 0-100 (higher=more conflict). Instructions will specify decisions about breast cancer screening.

Time frame
1 month

Other outcomes

1

MRI Knowledge

This breast MRI knowledge scale includes 10 true/false items based on the content of the breast MRI decision aid. Items are scored as correct (1) or incorrect (0); item scores are summed to create total scores (higher=greater knowledge). Adequate knowledge is specified as ≥50% correct.

Time frame
1 month
2

Screening Preferences

Respondents will rate factors that are viewed as important by people deciding about breast cancer screening (e.g., length of procedure, false positives, cost, etc.) on a 12-point scale ranging from "not at all important" (0) to "extremely important" (11). Items are averaged to create are averaged to create a total score ranging from 0-11 (lower=preference for screening with mammogram only, higher=preference for screening with mammogram + breast MRI).

Time frame
1 month
3

Screening Intentions

Participants will indicate screening intentions on a single item with a 7-point scale ranging from "mammogram only" (-3) to "mammogram + breast MRI" (3), with "unsure" as the mid-point (0).

Time frame
1 month
4

Enacted Decision

Receipt of MRI (yes/no) will be assessed via EMR review.

Time frame
6 months

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