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

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

Study Overview

• Status: Completed
• Conditions: Ductal Carcinoma in Situ
• Intervention / Treatment: Behavioral: Decision Support Tool with Active Monitoring; Behavioral: Decision Support Tool without Active Monitoring

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 Type: Interventional
• Enrollment (Actual): 322
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Mammography Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Treatment Options + Active Monitoring; Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.	Behavioral: 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.
Active Comparator: Standard Treatment Options; Participants explore decision support tool that includes current standard treatment options for DCIS.	Behavioral: Decision Support Tool without Active Monitoring; The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Breast Cancer Knowledge	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.	Up to 1 hour
Treatment Choice Reason	Measured post-tool as an open text field.	Up to 1 hour
Choice Confidence (Chambers et al., 2012)	Measured post-tool as categorical 5-point Likert scale from "Not at all confident" (1) to "Very confident" (5); analyzed as continuous variable.	Up to 1 hour
Information Needs Satisfaction (Adapted From Hess, 2012)	Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables.	Up to 1 hour
Knowledge Scale (De Novo)	Measured post-tool (3 questions).	Up to 1 hour
Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)	Measured post-tool (9 questions).	Up to 1 hour
Preparation for Decision Making (PDMS) (Bennett, et al., 2010)	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.	Up to 1 hour
Usability Question	Measured post-tool as an open text field.	Up to 1 hour
Aspects of Health Literacy Scale (AAHLS) (Chinn et al., 2013)	Measured post-tool as a 7-item scale, each item elicited on a scale from "Rarely" (1) to "Often" (3).	Up to 1 hour
Short Graph Literacy (Okan et al., 2019)	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).	Up to 1 hour
Medical Maximizer Minimizer Scale (Scherer et al., 2020)	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.	Up to 1 hour
Attitude Toward Risk (Zhang et al., 2019)	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).	Up to 1 hour
Pain Tolerance (McCracken et al., 1992; Two Questions From Each Subscale)	Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from "Never" (0) to "Always" (5).	Up to 1 hour
Importance of Appearance (Borzekowski et al., 2000)	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).	Up to 1 hour
Cancer Fear (Lerman Worry Scale, 1991)	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)	Up to 1 hour
Current Health: Visual Analog Scale (Adapted From EQ-5D-3L, EuroQol Group, 1990)	Self-reported health status (visual analog scale, 0-100).	Up to 1 hour

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Marc D Ryser, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Active surveillance; Ductal carcinoma in situ; Decision support tool; Informed decision-making; Overtreatment; Active monitoring
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Carcinoma; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: Pro00101109; 4R00CA207872-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No