Communication of Personalized Cancer Risk
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|ClinicalTrials.gov Identifier: NCT03775213|
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ductal Carcinoma in Situ||Behavioral: Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Mathematics of Breast Cancer Overtreatment: Improving Treatment Choice Through Effective Communication of Personalized Cancer Risk|
|Actual Study Start Date :||August 29, 2019|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||February 28, 2021|
Experimental: Standard Materials + Decision Aid
Participants receive standard materials used to communicate DCIS management choices, plus a decision aid.
Behavioral: Decision Aid
The decision aid will communicate trade-offs for different management strategies for DCIS, including active surveillance and active treatment.
No Intervention: Standard Materials
Participants receive standard materials used to communicate DCIS management choices.
- Acceptance of active surveillance [ Time Frame: Up to 1 hour ]Participants will report the probability of choosing active surveillance for their hypothetical diagnosis using a sliding visual scale; probability >50% will be classified as AS acceptance.
- Preferred management choice [ Time Frame: Up to 1 hour ]Participants report their preferred management choice among the following options: active surveillance, lumpectomy, lumpectomy with radiation, mastectomy.
- Decision aid acceptability [ Time Frame: Up to 1 hour ]Acceptability of the decision aid is measured using an existing validated tool.
- Comprehension of key decision aid content [ Time Frame: Up to 1 hour ]Understanding of key decision aid content is measured using an existing validated tool.
- Decisional conflict [ Time Frame: Up to 1 hour ]Decisional conflict is measured using an existing validated tool.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775213
|Contact: Jennifer Grant, MPHfirstname.lastname@example.org|
|United States, North Carolina|
|Duke Mammography Clinic||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Jennifer Grant, MPH 919-613-5953 email@example.com|
|Principal Investigator: Marc Ryser, PhD|
|Principal Investigator:||Marc D Ryser, PhD||Duke University|