Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

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

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

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

Decision Support Tool with Active Monitoring

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

Decision Support Tool without Active Monitoring

Marc D Ryser, PhD

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?

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

The Mathematics of Breast Cancer Overtreatment: Improving Treatment Choice Through Effective Communication of Personalized Cancer Risk

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

Measured post-tool as an open text field.

Measured post-tool as categorical 5-point Likert scale from "Not at all confident" (1) to "Very confident" (5); analyzed as continuous variable.

Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables.

Measured post-tool as 9-item scale, each item elicited on a 5-point Likert scale from "Not at all" (1) to "A great deal" (5); for each participant, the average score across 9 items is recorded and analyzed as a continuous variable.

Measured post-tool as a 7-item scale, each item elicited on a scale from "Rarely" (1) to "Often" (3).

Measured post-tool. Single score derived from 4 items, each scored as correct or incorrect. Correct answers are summed for a total "graph literacy score" (0-4).

Measured post-tool as categorical 6-point Likert scale from "I strongly lean toward waiting and seeing" (1) to "I strongly lean toward taking action" (6); analyzed as continuous variable.

Measured post-tool as an 8-item scale, each item elicited on a 5-point Likert scale from "Strongly disagree" (1) to "Strongly agree" (5).

Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from "Never" (0) to "Always" (5).

Measured post-tool as a 4-item scale, each item elicited on a 6-point Likert scale from "Not at all important compared to other things in my life" (1) to "The very most important thing in my life" (6).

Measured post-tool as a 3-item scale, each item elicited on a 5-point Likert scale from "Not at all" (1) to "Almost all the time" (5)

Self-reported health status (visual analog scale, 0-100).

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

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".

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".

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

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.

National Cancer Institute (NCI)

Duke University

Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.

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

Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.

Standard Treatment Options + Active Monitoring

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

Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.

Standard Treatment Options

Total

Age, Continuous

50-64 years

65-79 years

Age, Customized

Sex: Female, Male

White

Black

Other

Race/Ethnicity, Customized

In Relationship

Married

Divorced

Separated

Single

Marital Status

Some High School

High School

Bachelor's Degree

Master's Degree

Professional Degree (e.g., MD, JD)

Doctorate Degree (e.g., PhD)

Education

Extra for special

Just enough

Cut back to pay bills

Difficulty paying bills

Household Finances

Self-Reported Health Status measured on a visual analog scale (0-100%), with 0 being the worst outcome and 100 being the best outcome.

Self-Reported Health Status, Median (Q1, Q3)

Personal Cancer History

Family Cancer History

This categorical 6-point Likert scale ranges from "I strongly lean toward waiting and seeing" (1) to "I strongly lean toward taking action" (6). The scale captures the extent to which individuals are "medical maximizers" who are predisposed to seek health care even for minor problems, versus "medical minimizers" who prefer to avoid medical intervention unless it is necessary.

Maximizer Minimizer Scale, Median (Q1, Q3)

Single score derived from 3 items, each scored as correct or incorrect. Correct answers are summed for a total "graph literacy score" (0-3). Lower scores indicate worse outcomes, and higher scores indicate better outcomes.

Graph Literacy Score (0-3), Median (Q1, Q3)

5-point Likert scale from "I know very little about breast cancer" (1) to "I know a lot about breast cancer" (5).

Pre-tool Knowledge (1-5): Breast Cancer

5-point Likert scale from "I know very little about DCIS" (1) to "I know a lot about DCIS" (5).

Pre-tool Knowledge (1-5): DCIS

Dr. Marc D. Ryser

Number of Participants Who Chose Active Monitoring (AM).

Active Monitoring

Lumpectomy

Lumpectomy with Radiation

Mastectomy

Number of Participants Who Found the Treatment Option Acceptable.

Number of Participants Who Perceived Active Monitoring as Risky.

Number of Participants Who Chose Mastectomy.

Change in Self-perceived Knowledge About DCIS.

Self-reported Breast Cancer Knowledge

Treatment Choice Reason

Choice Confidence (Chambers et al., 2012)

Information Needs Satisfaction (Adapted From Hess, 2012)

Knowledge Scale (De Novo)

Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)

Preparation for Decision Making (PDMS) (Bennett, et al., 2010)

Usability Question

Aspects of Health Literacy Scale (AAHLS) (Chinn et al., 2013)

Short Graph Literacy (Okan et al., 2019)

Medical Maximizer Minimizer Scale (Scherer et al., 2020)

Attitude Toward Risk (Zhang et al., 2019)

Pain Tolerance (McCracken et al., 1992; Two Questions From Each Subscale)

Importance of Appearance (Borzekowski et al., 2000)

Cancer Fear (Lerman Worry Scale, 1991)

Current Health: Visual Analog Scale (Adapted From EQ-5D-3L, EuroQol Group, 1990)

Participants explore decision support tool that includes current standard treatment options for ductal carcinoma in situ (DCIS), as well as active monitoring (AM).

Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.

Standard Treatment Options + Active Monitoring (AM)

Participants explore decision support tool that includes current standard treatment options for ductal carcinoma in situ (DCIS).

Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)	NCT03775213	Ductal Carcinom...	Decision Suppor... Decision Suppor...	50 Years - 79 Years	Duke University
Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)	NCT03775213	Ductal Carcinom...	Decision Suppor... Decision Suppor...	50 Years - 79 Years	Duke University

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