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

Ductal Carcinoma in Situ Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775213
• Other study ID #: Pro00101109
• Secondary ID: 4R00CA207872-03
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ

Intervention

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

Locations

Country	Name	City	State
United States	Duke Mammography Clinic	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Treatment Choice Reason	Measured post-tool as an open text field.	Up to 1 hour
Other	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
Other	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
Other	Knowledge Scale (De Novo)	Measured post-tool (3 questions).	Up to 1 hour
Other	Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)	Measured post-tool (9 questions).	Up to 1 hour
Other	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
Other	Usability Question	Measured post-tool as an open text field.	Up to 1 hour
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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