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

Duke University

Status: Completed

Conditions: Ductal Carcinoma in Situ

Treatments: Behavioral: Decision Support Tool without Active Monitoring; Behavioral: Decision Support Tool with Active Monitoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03775213

4R00CA207872-03 (U.S. NIH Grant/Contract)

Pro00101109

Details and patient eligibility

About

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

Full 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?

Enrollment: 322 patients

Sex: Female

Ages: 50 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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322 participants in 2 patient groups

Standard Treatment Options + Active Monitoring

Experimental group

Description:

Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.

Treatment:

Behavioral: Decision Support Tool with Active Monitoring

Standard Treatment Options

Active Comparator group

Description:

Participants explore decision support tool that includes current standard treatment options for DCIS.

Treatment:

Behavioral: Decision Support Tool without Active Monitoring