An interventional study of Decision Support Tool with Active Monitoring and Decision Support Tool without Active Monitoring in Ductal Carcinoma in Situ, sponsored by Duke University. Completed at 1 site in United States. Open to female participants aged 50 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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?
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 322 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 active monitoring and surgery options.
The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
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.
Time frame: Up to 1 hour
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".
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 1 hour
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.
Time frame: Up to 1 hour
Treatment Choice Reason
Measured post-tool as an open text field.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 hour
Knowledge Scale (De Novo)
Measured post-tool (3 questions).
Time frame: Up to 1 hour
Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)
Measured post-tool (9 questions).
Time frame: 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.
Time frame: Up to 1 hour
Usability Question
Measured post-tool as an open text field.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: Up to 1 hour
Participants were recruited from Duke mammography clinics between October 2021 and January 2022. The first participant was enrolled on October 12th, 2021 and the last participant was enrolled on January 29th, 2022.
| Milestone | Standard Treatment Options + Active Monitoring (AM) | Standard Treatment Options |
|---|---|---|
| Started | 160 | 162 |
| Completed | 102 | 102 |
| Not completed | 58 | 60 |
| Withdrew: Withdrawal by subject | 51 | 53 |
| Withdrew: Incomplete survey | 7 | 7 |
Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.
| Participants | Standard Treatment Options + Active Monitoring | Standard Treatment Options |
|---|---|---|
| Number of Participants Who Chose Active Monitoring (AM). | 28 | 18 |
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".
| Participants | Standard Treatment Options + Active Monitoring | Standard Treatment Options |
|---|---|---|
| Active Monitoring | 32 | 32 |
| Lumpectomy | 50 | 47 |
| Lumpectomy with Radiation | 34 | 38 |
| Mastectomy | 18 | 22 |
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".
| Participants | Standard Treatment Options + Active Monitoring | Standard Treatment Options |
|---|---|---|
| Number of Participants Who Perceived Active Monitoring as Risky. | 18 | 17 |
Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.
| Participants | Standard Treatment Options + Active Monitoring | Standard Treatment Options |
|---|---|---|
| Number of Participants Who Chose Mastectomy. | 14 | 15 |
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.
| Units on a scale | Standard Treatment Options + Active Monitoring | Standard Treatment Options |
|---|---|---|
| Change in Self-perceived Knowledge About DCIS. | 2 (2 to 3) | 2.5 (2 to 3) |
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.
Results for this outcome have not been posted.
Measured post-tool as an open text field.
Results for this outcome have not been posted.
Measured post-tool as categorical 5-point Likert scale from "Not at all confident" (1) to "Very confident" (5); analyzed as continuous variable.
Results for this outcome have not been posted.
Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables.
Results for this outcome have not been posted.
Measured post-tool (3 questions).
Results for this outcome have not been posted.
Measured post-tool (9 questions).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Measured post-tool as an open text field.
Results for this outcome have not been posted.
Measured post-tool as a 7-item scale, each item elicited on a scale from "Rarely" (1) to "Often" (3).
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from "Never" (0) to "Always" (5).
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
Self-reported health status (visual analog scale, 0-100).
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Treatment Options + Active Monitoring | — | — | — |
| Standard Treatment Options | — | — | — |
| Age, Continuous(years) | Standard Treatment Options + Active Monitoring | Standard Treatment Options | Total |
|---|---|---|---|
| Median | 64 (57 to 69) | 62 (56 to 67) | 62 (57 to 68) |
| Age, Customized(Participants) | Standard Treatment Options + Active Monitoring | Standard Treatment Options | Total |
|---|---|---|---|
| 50-64 years | 55 | 61 | 116 |
| 65-79 years | 47 | 41 | 88 |
| Sex: Female, Male(Participants) | Standard Treatment Options + Active Monitoring | Standard Treatment Options | Total |
|---|---|---|---|
| Female | 102 | 102 | 204 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Standard Treatment Options + Active Monitoring | Standard Treatment Options | Total |
|---|---|---|---|
| White | 69 | 63 | 132 |
| Black | 29 | 37 | 66 |
| Other | 4 | 2 | 6 |
| Marital Status(Participants) | Standard Treatment Options + Active Monitoring | Standard Treatment Options | Total |
|---|---|---|---|
| In Relationship | 6 | 8 | 14 |
| Married | 73 | 60 | 133 |
| Divorced | 8 | 13 | 21 |
| Separated | 0 | 2 | 2 |
| Single | 14 | 15 | 29 |
| Other | 1 | 4 | 5 |
| Education(Participants) | Standard Treatment Options + Active Monitoring | Standard Treatment Options | Total |
|---|---|---|---|
| Some High School | 2 | 1 | 3 |
| High School | 14 | 19 | 33 |
| Bachelor's Degree | 47 | 40 | 87 |
| Master's Degree | 29 | 30 | 59 |
| Professional Degree (e.g., MD, JD) | 5 | 9 | 14 |
| Doctorate Degree (e.g., PhD) | 5 | 3 | 8 |
| Household Finances(Participants) | Standard Treatment Options + Active Monitoring | Standard Treatment Options | Total |
|---|---|---|---|
| Extra for special | 78 | 72 | 150 |
| Just enough | 16 | 23 | 39 |
| Cut back to pay bills | 8 | 3 | 11 |
| Difficulty paying bills | 0 | 4 | 4 |
| Self-Reported Health Status, Median (Q1, Q3)(units on a scale) | Standard Treatment Options + Active Monitoring | Standard Treatment Options | Total |
|---|---|---|---|
| Median | 83 (75 to 90) | 85 (75 to 90) | 83.5 (75 to 90) |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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