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Completed

NCT Number: NCT03775213

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

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

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Key information

Conditions

Ductal Carcinoma in Situ Adenocarcinoma Breast Carcinoma In Situ Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial

Age range

50 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke Mammography Clinic

Durham, North Carolina, 27710, United States

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Decision Support Tool without Active Monitoring

Behavioral

The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.

Primary outcomes

  1. Number of Participants Who Chose Active Monitoring (AM).

    Time frame: 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 outcomes

  1. Number of Participants Who Found the Treatment Option Acceptable.

    Time frame: 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".

  2. Number of Participants Who Perceived Active Monitoring as Risky.

    Time frame: 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".

  3. Number of Participants Who Chose Mastectomy.

    Time frame: 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.

  4. Change in Self-perceived Knowledge About DCIS.

    Time frame: 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 outcomes

  1. Self-reported Breast Cancer Knowledge

    Time frame: 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.

  2. Treatment Choice Reason

    Time frame: Up to 1 hour

    Measured post-tool as an open text field.

  3. Choice Confidence (Chambers et al., 2012)

    Time frame: 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.

  4. Information Needs Satisfaction (Adapted From Hess, 2012)

    Time frame: 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.

  5. Knowledge Scale (De Novo)

    Time frame: Up to 1 hour

    Measured post-tool (3 questions).

  6. Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)

    Time frame: Up to 1 hour

    Measured post-tool (9 questions).

  7. Preparation for Decision Making (PDMS) (Bennett, et al., 2010)

    Time frame: 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.

  8. Usability Question

    Time frame: Up to 1 hour

    Measured post-tool as an open text field.

  9. Aspects of Health Literacy Scale (AAHLS) (Chinn et al., 2013)

    Time frame: Up to 1 hour

    Measured post-tool as a 7-item scale, each item elicited on a scale from "Rarely" (1) to "Often" (3).

  10. Short Graph Literacy (Okan et al., 2019)

    Time frame: 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).

  11. Medical Maximizer Minimizer Scale (Scherer et al., 2020)

    Time frame: 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.

  12. Attitude Toward Risk (Zhang et al., 2019)

    Time frame: 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).

  13. Pain Tolerance (McCracken et al., 1992; Two Questions From Each Subscale)

    Time frame: 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).

  14. Importance of Appearance (Borzekowski et al., 2000)

    Time frame: 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).

  15. Cancer Fear (Lerman Worry Scale, 1991)

    Time frame: 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)

  16. Current Health: Visual Analog Scale (Adapted From EQ-5D-3L, EuroQol Group, 1990)

    Time frame: Up to 1 hour

    Self-reported health status (visual analog scale, 0-100).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2018
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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