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

Not Applicable

Completed

• Conditions: Ductal Carcinoma in Situ
• Interventions: Behavioral: Decision Support Tool without Active Monitoring; Behavioral: Decision Support Tool with Active Monitoring

• Registration Number: NCT03775213
• Lead Sponsor: Duke University

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Study Start: 2021-10-12
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Results First Submitted: 2022-12-02
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-04
• Last Update Submitted: 2023-01-04
• Results First Posted: 2023-01-30
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 322

Inclusion Criteria

• Sex: Female
• Age: 50-79 years
• Has had a negative mammographic screen in the past 12 months

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Exclusion Criteria

• Personal history of breast cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment Options	Decision Support Tool without Active Monitoring	Participants explore decision support tool that includes current standard treatment options for DCIS.
Standard Treatment Options + Active Monitoring	Decision Support Tool with Active Monitoring	Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Chose Active Monitoring (AM).	Up to 1 hour	Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Perceived Active Monitoring as Risky.	Up to 1 hour	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".
Number of Participants Who Chose Mastectomy.	Up to 1 hour	Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.
Change in Self-perceived Knowledge About DCIS.	Baseline and 1 hour	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.
Number of Participants Who Found the Treatment Option Acceptable.	Up to 1 hour	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".

Trial Locations

Locations (1)

Duke Mammography Clinic; 🇺🇸 Durham, North Carolina, United States