Clinical trial NCT03775213: Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)
Official title: The Mathematics of Breast Cancer Overtreatment: Improving Treatment Choice Through Effective Communication of Personalized Cancer Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ductal Carcinoma in Situ
Keywords: Ductal carcinoma in situ
Decision support tool
Informed decision-making
Overtreatment
Active surveillance
Active monitoring
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-12-13
Enrollment: 322
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Chose Active Monitoring (AM).
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Number of Participants Who Found the Treatment Option Acceptable.
timeFrame: Up to 1 hour
measure: Number of Participants Who Perceived Active Monitoring as Risky.
timeFrame: Up to 1 hour
measure: Number of Participants Who Chose Mastectomy.
timeFrame: Up to 1 hour
measure: Change in Self-perceived Knowledge About DCIS.
timeFrame: Baseline and 1 hour
Other outcomes:
measure: Self-reported Breast Cancer Knowledge
timeFrame: Up to 1 hour
measure: Treatment Choice Reason
timeFrame: Up to 1 hour
measure: Choice Confidence (Chambers et al., 2012)
timeFrame: Up to 1 hour
measure: Information Needs Satisfaction (Adapted From Hess, 2012)
timeFrame: Up to 1 hour
measure: Knowledge Scale (De Novo)
timeFrame: Up to 1 hour
measure: Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)
timeFrame: Up to 1 hour
measure: Preparation for Decision Making (PDMS) (Bennett, et al., 2010)
timeFrame: Up to 1 hour
measure: Usability Question
timeFrame: Up to 1 hour
measure: Aspects of Health Literacy Scale (AAHLS) (Chinn et al., 2013)
timeFrame: Up to 1 hour
measure: Short Graph Literacy (Okan et al., 2019)
timeFrame: Up to 1 hour
measure: Medical Maximizer Minimizer Scale (Scherer et al., 2020)
timeFrame: Up to 1 hour
measure: Attitude Toward Risk (Zhang et al., 2019)
timeFrame: Up to 1 hour
measure: Pain Tolerance (McCracken et al., 1992; Two Questions From Each Subscale)
timeFrame: Up to 1 hour
measure: Importance of Appearance (Borzekowski et al., 2000)
timeFrame: Up to 1 hour
measure: Cancer Fear (Lerman Worry Scale, 1991)
timeFrame: Up to 1 hour
measure: Current Health: Visual Analog Scale (Adapted From EQ-5D-3L, EuroQol Group, 1990)
timeFrame: Up to 1 hour
Locations:
city: Durham
country: United States
facility: Duke Mammography Clinic
state: North Carolina
Study officials:
affiliation: Duke University
name: Marc D Ryser, PhD
role: PRINCIPAL_INVESTIGATOR
References: