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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00CA207872-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment Options + Active Monitoring | Experimental | Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. |
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| Standard Treatment Options | Active Comparator | Participants explore decision support tool that includes current standard treatment options for DCIS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Support Tool with Active Monitoring | Behavioral | The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc D Ryser, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Mammography Clinic | Durham | North Carolina | 27710 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment Options + Active Monitoring (AM) | 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. |
| FG001 | Standard Treatment Options | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 1 hour |
|
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Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc D. Ryser | Duke University | (919) 684 8294 | marc.ryser@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2022 | Nov 11, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2021 | Aug 25, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2021 | Apr 4, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Decision Support Tool without Active Monitoring | Behavioral | The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only. |
|
| 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 |
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 |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Household Finances | Count of Participants | Participants |
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| Self-Reported Health Status, Median (Q1, Q3) | Self-Reported Health Status measured on a visual analog scale (0-100%), with 0 being the worst outcome and 100 being the best outcome. | Median | Inter-Quartile Range | units on a scale |
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| Personal Cancer History | Count of Participants | Participants |
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| Family Cancer History | Count of Participants | Participants |
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| Maximizer Minimizer Scale, Median (Q1, Q3) | 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. | Median | Inter-Quartile Range | units on a scale |
|
| Graph Literacy Score (0-3), 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. | Median | Inter-Quartile Range | units on a scale |
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| Pre-tool Knowledge (1-5): Breast Cancer | 5-point Likert scale from "I know very little about breast cancer" (1) to "I know a lot about breast cancer" (5). | Median | Inter-Quartile Range | units on a scale |
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| Pre-tool Knowledge (1-5): DCIS | 5-point Likert scale from "I know very little about DCIS" (1) to "I know a lot about DCIS" (5). | Median | Inter-Quartile Range | units on a scale |
|
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.
|
|
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| 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". | Posted | Count of Participants | Participants | Up to 1 hour |
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| 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". | Posted | Count of Participants | Participants | Up to 1 hour |
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| 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. | Posted | Count of Participants | Participants | Up to 1 hour |
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| 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. | Posted | Median | Inter-Quartile Range | Units on a scale | Baseline and 1 hour |
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| 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. | Not Posted | Up to 1 hour | Participants |
| Other Pre-specified | Treatment Choice Reason | Measured post-tool as an open text field. | Not Posted | Up to 1 hour | Participants |
| 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. | Not Posted | Up to 1 hour | Participants |
| 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. | Not Posted | Up to 1 hour | Participants |
| Other Pre-specified | Knowledge Scale (De Novo) | Measured post-tool (3 questions). | Not Posted | Up to 1 hour | Participants |
| Other Pre-specified | Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019) | Measured post-tool (9 questions). | Not Posted | Up to 1 hour | Participants |
| 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. | Not Posted | Up to 1 hour | Participants |
| Other Pre-specified | Usability Question | Measured post-tool as an open text field. | Not Posted | Up to 1 hour | Participants |
| 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). | Not Posted | Up to 1 hour | Participants |
| 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). | Not Posted | Up to 1 hour | Participants |
| 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. | Not Posted | Up to 1 hour | Participants |
| 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). | Not Posted | Up to 1 hour | Participants |
| 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). | Not Posted | Up to 1 hour | Participants |
| 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). | Not Posted | Up to 1 hour | Participants |
| 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) | Not Posted | Up to 1 hour | Participants |
| 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). | Not Posted | Up to 1 hour | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| Lumpectomy with Radiation |
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| Mastectomy |
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| Risk Ratio (RR) |
| 1.06 |
| 2-Sided |
| 95 |
| .79 |
| 1.41 |
| Superiority |
| Lumpectomy with Radiation | Risk Ratio (RR) | .90 | 2-Sided | 95 | .62 | 1.30 | Superiority |
| Mastectomy | Risk Ratio (RR) | .84 | 2-Sided | 95 | .48 | 1.47 | Superiority |