Ductal Carcinoma in Situ
Conditions
Keywords
Ductal carcinoma in situ, Decision support tool, Informed decision-making, Overtreatment, Active surveillance, Active monitoring
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?
Interventions
BEHAVIORALDecision Support Tool with Active Monitoring
The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
BEHAVIORALDecision Support Tool without Active Monitoring
The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Sponsors
National Cancer Institute (NCI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Chose Active Monitoring (AM). | Up to 1 hour | Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Found the Treatment Option Acceptable. | Up to 1 hour | 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. |
| Number of Participants Who Perceived Active Monitoring as Risky. | Up to 1 hour | 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. |
| Number of Participants Who Chose Mastectomy. | Up to 1 hour | Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy. |
| Change in Self-perceived Knowledge About DCIS. | Baseline and 1 hour | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Knowledge Scale (De Novo) | Up to 1 hour | Measured post-tool (3 questions). |
| Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019) | Up to 1 hour | Measured post-tool (9 questions). |
| Preparation for Decision Making (PDMS) (Bennett, et al., 2010) | Up to 1 hour | 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. |
| Usability Question | Up to 1 hour | Measured post-tool as an open text field. |
| Aspects of Health Literacy Scale (AAHLS) (Chinn et al., 2013) | Up to 1 hour | Measured post-tool as a 7-item scale, each item elicited on a scale from Rarely (1) to Often (3). |
| Short Graph Literacy (Okan et al., 2019) | Up to 1 hour | 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). |
| Attitude Toward Risk (Zhang et al., 2019) | Up to 1 hour | 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). |
| Pain Tolerance (McCracken et al., 1992; Two Questions From Each Subscale) | Up to 1 hour | Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from Never (0) to Always (5). |
| Importance of Appearance (Borzekowski et al., 2000) | Up to 1 hour | 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). |
| Cancer Fear (Lerman Worry Scale, 1991) | Up to 1 hour | 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) |
| Current Health: Visual Analog Scale (Adapted From EQ-5D-3L, EuroQol Group, 1990) | Up to 1 hour | Self-reported health status (visual analog scale, 0-100). |
| Medical Maximizer Minimizer Scale (Scherer et al., 2020) | Up to 1 hour | 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. |
| Self-reported Breast Cancer Knowledge | Up to 1 hour | 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. |
| Treatment Choice Reason | Up to 1 hour | Measured post-tool as an open text field. |
| Choice Confidence (Chambers et al., 2012) | Up to 1 hour | Measured post-tool as categorical 5-point Likert scale from Not at all confident (1) to Very confident (5); analyzed as continuous variable. |
| Information Needs Satisfaction (Adapted From Hess, 2012) | Up to 1 hour | Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment Options + Active Monitoring 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. | 102 |
| Standard Treatment Options 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. | 102 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete Survey | 7 | 7 |
| Overall Study | Withdrawal by Subject | 51 | 53 |
Baseline characteristics
| Characteristic | Standard Treatment Options | Total | Standard Treatment Options + Active Monitoring |
|---|---|---|---|
| Age, Continuous | 62 years | 62 years | 64 years |
| Age, Customized 50-64 years | 61 Participants | 116 Participants | 55 Participants |
| Age, Customized 65-79 years | 41 Participants | 88 Participants | 47 Participants |
| Education Bachelor's Degree | 40 Participants | 87 Participants | 47 Participants |
| Education Doctorate Degree (e.g., PhD) | 3 Participants | 8 Participants | 5 Participants |
| Education High School | 19 Participants | 33 Participants | 14 Participants |
| Education Master's Degree | 30 Participants | 59 Participants | 29 Participants |
| Education Professional Degree (e.g., MD, JD) | 9 Participants | 14 Participants | 5 Participants |
| Education Some High School | 1 Participants | 3 Participants | 2 Participants |
| Family Cancer History | 81 Participants | 167 Participants | 86 Participants |
| Graph Literacy Score (0-3), Median (Q1, Q3) | 2.0 units on a scale | 2.0 units on a scale | 2.0 units on a scale |
| Household Finances Cut back to pay bills | 3 Participants | 11 Participants | 8 Participants |
| Household Finances Difficulty paying bills | 4 Participants | 4 Participants | 0 Participants |
| Household Finances Extra for special | 72 Participants | 150 Participants | 78 Participants |
| Household Finances Just enough | 23 Participants | 39 Participants | 16 Participants |
| Marital Status Divorced | 13 Participants | 21 Participants | 8 Participants |
| Marital Status In Relationship | 8 Participants | 14 Participants | 6 Participants |
| Marital Status Married | 60 Participants | 133 Participants | 73 Participants |
| Marital Status Other | 4 Participants | 5 Participants | 1 Participants |
| Marital Status Separated | 2 Participants | 2 Participants | 0 Participants |
| Marital Status Single | 15 Participants | 29 Participants | 14 Participants |
| Maximizer Minimizer Scale, Median (Q1, Q3) | 4.0 units on a scale | 4.0 units on a scale | 4.0 units on a scale |
| Personal Cancer History | 25 Participants | 54 Participants | 29 Participants |
| Pre-tool Knowledge (1-5): Breast Cancer | 3.0 units on a scale | 3.0 units on a scale | 3.0 units on a scale |
| Pre-tool Knowledge (1-5): DCIS | 1.0 units on a scale | 1.0 units on a scale | 1.0 units on a scale |
| Race/Ethnicity, Customized Black | 37 Participants | 66 Participants | 29 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 63 Participants | 132 Participants | 69 Participants |
| Self-Reported Health Status, Median (Q1, Q3) | 85 units on a scale | 83.5 units on a scale | 83 units on a scale |
| Sex: Female, Male Female | 102 Participants | 204 Participants | 102 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Up to 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment Options + Active Monitoring | Number of Participants Who Chose Active Monitoring (AM). | 28 Participants |
| Standard Treatment Options | Number of Participants Who Chose Active Monitoring (AM). | 18 Participants |
95% CI: [0.91, 2.58]
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.
Time frame: Baseline and 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Treatment Options + Active Monitoring | Change in Self-perceived Knowledge About DCIS. | 2 Units on a scale |
| Standard Treatment Options | Change in Self-perceived Knowledge About DCIS. | 2.5 Units on a scale |
95% CI: [-0.2, 0.38]
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.
Time frame: Up to 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment Options + Active Monitoring | Number of Participants Who Chose Mastectomy. | 14 Participants |
| Standard Treatment Options | Number of Participants Who Chose Mastectomy. | 15 Participants |
95% CI: [0.65, 1.45]
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.
Time frame: Up to 1 hour
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Treatment Options + Active Monitoring | Number of Participants Who Found the Treatment Option Acceptable. | Active Monitoring | 32 Participants |
| Standard Treatment Options + Active Monitoring | Number of Participants Who Found the Treatment Option Acceptable. | Lumpectomy | 50 Participants |
| Standard Treatment Options + Active Monitoring | Number of Participants Who Found the Treatment Option Acceptable. | Mastectomy | 18 Participants |
| Standard Treatment Options + Active Monitoring | Number of Participants Who Found the Treatment Option Acceptable. | Lumpectomy with Radiation | 34 Participants |
| Standard Treatment Options | Number of Participants Who Found the Treatment Option Acceptable. | Lumpectomy with Radiation | 38 Participants |
| Standard Treatment Options | Number of Participants Who Found the Treatment Option Acceptable. | Active Monitoring | 32 Participants |
| Standard Treatment Options | Number of Participants Who Found the Treatment Option Acceptable. | Mastectomy | 22 Participants |
| Standard Treatment Options | Number of Participants Who Found the Treatment Option Acceptable. | Lumpectomy | 47 Participants |
Comparison: Active Monitoring95% CI: [0.49, 1.88]
Comparison: Lumpectomy95% CI: [0.79, 1.41]
Comparison: Lumpectomy with Radiation95% CI: [0.62, 1.3]
Comparison: Mastectomy95% CI: [0.48, 1.47]
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.
Time frame: Up to 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment Options + Active Monitoring | Number of Participants Who Perceived Active Monitoring as Risky. | 18 Participants |
| Standard Treatment Options | Number of Participants Who Perceived Active Monitoring as Risky. | 17 Participants |
95% CI: [0.59, 1.98]
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)
Measured post-tool (9 questions).
Time frame: Up to 1 hour
Other Pre-specified
Knowledge Scale (De Novo)
Measured post-tool (3 questions).
Time frame: Up to 1 hour
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
Treatment Choice Reason
Measured post-tool as an open text field.
Time frame: Up to 1 hour
Other Pre-specified
Usability Question
Measured post-tool as an open text field.
Time frame: Up to 1 hour