Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)
Condition: Ductal Carcinoma in Situ
MeSH terms: Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Study type: Interventional

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?
    

Intervention name(s): Decision Support Tool with Active Monitoring; Decision Support Tool without Active Monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.; The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Ductal carcinoma in situ; Decision support tool; Informed decision-making; Overtreatment; Active surveillance; Active monitoring