Acceptability of Active Monitoring as a Treatment Option for Ductal Carcinoma in Situ (DCIS)
Study Details
Study Description
Brief Summary
The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Today, guideline concordant care options for patients diagnosed with 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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Post-tool choice of active monitoring (AM). [Up to 1 hour]
Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.
Secondary Outcome Measures
- Post-tool acceptability of the different treatment options. [Up to 1 hour]
Measured as categorical 5-point Likert scale from "Not at all comfortable" (1) to "Very comfortable" (5); analyzed as continuous variable.
- Subjective perception of active monitoring riskiness. [Up to 1 hour]
Measured as categorical 5-point Likert scale from "Not at all likely" (1) to "Very likely" (5); analyzed as continuous variable.
- Post-tool mastectomy choice. [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. [Up to 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 Outcome Measures
- 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.
- 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).
- 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.
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Sex: Female
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Age: 50-79 years
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Has had a negative mammographic screen in the past 12 months
Exclusion Criteria:
- Personal history of breast cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Mammography Clinic | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Marc D Ryser, PhD, Duke University
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00101109
- 4R00CA207872-03