Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)

Duke University322 enrolled

Overview

The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS).

Today, guideline concordant care options for patients diagnosed with ductal carcinoma in situ (DCIS) are lumpectomy (with or without radiation treatment) and mastectomy, with optional endocrine therapy. Several ongoing trials are evaluating the safety of active monitoring (AM) as an alternative to immediate surgery for select patient groups. Little is known about women's acceptability of AM after a diagnosis with DCIS. Here the study team seeks to answer the question: if AM is found to be a safe alternative to immediate surgery, how likely are women to choose it as their first course of treatment? In this study, women are asked to imagine having recently been diagnosed with DCIS. For some in the intervention arm, in-depth information about surgical options and AM are presented with a web-based decision support tool. After exploring the decision support tool, participants are asked to make a hypothetical treatment choice and to answer a series of additional questions about their decision-making process and personal preferences. Women in the control arm receive a reduced version of the decision support tool that only provides in-depth information about the surgical options (AM is mentioned as an experimental approach). The overarching hypothesis of this study is that patients who are offered AM as a guideline-concordant care option (a potential future scenario if ongoing trials confirm the safety of AM) are more likely to choose it compared to women in current clinical practice (who receive information about surgical options only). Primary research question: Compared to presenting active monitoring (AM) as an experimental option, does presenting AM as a guideline-concordant care option increase its uptake as treatment choice? Secondary research questions: Compared to presenting active monitoring (AM) as an experimental option, does presenting active monitoring as a guideline-concordant care option increase AM acceptability, decrease perceived AM riskiness, and decrease uptake of mastectomy as treatment choice?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

322

Conditions

Ductal Carcinoma in Situ

Interventions

Decision Support Tool with Active MonitoringBEHAVIORAL

The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.

Decision Support Tool without Active MonitoringBEHAVIORAL

The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Sex: Female * Age: 50-79 years * Has had a negative mammographic screen in the past 12 months Exclusion Criteria: * Personal history of breast cancer

Locations (1)

Duke Mammography Clinic

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Number of Participants Who Chose Active Monitoring (AM).

Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.

Time frame: Up to 1 hour

Secondary Outcomes

Number of Participants Who Found the Treatment Option Acceptable.

Acceptability was ascertained using 1-5 Likert scale. Acceptability, asked in terms of comfort with a given treatment choice, was anchored at 1="Not at all comfortable" and 5="Very comfortable." The outcome was dichotomized using responses of 4 or 5 to represent "Acceptable".

Time frame: Up to 1 hour

Number of Participants Who Perceived Active Monitoring as Risky.

Perceived risk outcome was ascertained using 1-5 Likert scale. Perceived risk was asked for active monitoring only, and was anchored at 1="Not at all risky" and 5="Very risky". The outcome was dichotomized using responses of 4 or 5 to represent "Risky".

Time frame: Up to 1 hour

Number of Participants Who Chose Mastectomy.

Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.

Time frame: Up to 1 hour

Change in Self-perceived Knowledge About DCIS.

Measured pre- and post-tool as a categorical 5-point Likert scale from "I know very little about DCIS" (1) to "I know a lot about DCIS" (5); analyzed as continuous variable.

Time frame: Baseline and 1 hour

Data from ClinicalTrials.gov

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