Ductal Carcinoma in SituNCT03775213
Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)
A study testing Decision Support Tool with Active Monitoring and Decision Support Tool without Active Monitoring in people with Ductal Carcinoma in Situ, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS). Read more about this study
- Who is it for?
- Ages 50 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- Decision Support Tool with Active Monitoring and Decision Support Tool without Active Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: Female
- Age: 50-79 years
- Has had a negative mammographic screen in the past 12 months
Who cannot join
- Personal history of breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Mammography Clinic
Durham, North Carolina, 27710
About this study
Official title: The Mathematics of Breast Cancer Overtreatment: Improving Treatment Choice Through Effective Communication of Personalized Cancer Risk
The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS).
Read the 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?
- Conditions
- Ductal Carcinoma in Situ
- Being tested
- Decision Support Tool with Active Monitoring, Decision Support Tool without Active Monitoring
- Keywords
- Ductal carcinoma in situ, Decision support tool, Informed decision-making, Overtreatment, Active surveillance, Active monitoring
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support Tool with Active MonitoringBehavioural
The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Decision Support Tool without Active MonitoringBehavioural
The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment Options + Active Monitoring | Experimental | Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. Receives: Behavioral: Decision Support Tool with Active Monitoring |
| Standard Treatment Options | Active comparator | Participants explore decision support tool that includes current standard treatment options for DCIS. Receives: Behavioral: Decision Support Tool without Active Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 hour
Secondary outcomes (4)
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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Baseline and 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start12 Oct 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marc D Ryser, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775213
- Sponsor's protocol ID
- Pro00101109
- Other IDs
- 4R00CA207872-03
- Status last verified
- Jan 2023
- First submitted
- 11 Dec 2018
- Last updated
- 30 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mathematics of Breast Cancer Overtreatment: Improving Treatment Choice Through Effective Communication of Personalized Cancer Risk
- ClinicalTrials.gov ID
- NCT03775213
- Acronym / sponsor ID
- Pro00101109
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- Ductal carcinoma in situ, Decision support tool, Informed decision-making, Overtreatment, Active surveillance, Active monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Posted 30 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Options + Active Monitoring | Experimental | Behavioral: Decision Support Tool with Active MonitoringParticipants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring. |
| Standard Treatment Options | Active comparator | Behavioral: Decision Support Tool without Active MonitoringParticipants explore decision support tool that includes current standard treatment options for DCIS. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sex: Female
- Age: 50-79 years
- Has had a negative mammographic screen in the past 12 months
Key exclusion criteria (1 listed)
- Personal history of breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Support Tool with Active MonitoringThe decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options. | Behavioural | Standard Treatment Options + Active Monitoring |
| Decision Support Tool without Active MonitoringThe decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only. | Behavioural | Standard Treatment Options |
Primary outcome
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.
4 secondary outcomes
Number of Participants Who Found the Treatment Option Acceptable.
Time frame: Up to 1 hour
Number of Participants Who Perceived Active Monitoring as Risky.
Time frame: Up to 1 hour
Number of Participants Who Chose Mastectomy.
Time frame: Up to 1 hour
Change in Self-perceived Knowledge About DCIS.
Time frame: Baseline and 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc D Ryser, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support Tool with Active Monitoring and Decision Support Tool without Active Monitoring in people with Ductal Carcinoma in Situ, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Chose Active Monitoring (AM). (time frame: Up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.