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Communication of Personalized Cancer Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775213
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this research study is to develop a personalized decision support tool that will maximize informed decision-making and minimize overtreatment in patients diagnosed with ductal carcinoma in situ (DCIS).

Condition or disease Intervention/treatment Phase
Ductal Carcinoma in Situ Behavioral: Decision Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Decision aid acceptability [ Time Frame: Up to 1 hour ]
    Acceptability of the decision aid is measured using an existing validated tool.

  3. 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.

  4. Decisional conflict [ Time Frame: Up to 1 hour ]
    Decisional conflict is measured using an existing validated tool.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sex: Female
  • Age: 50-79 years
  • Has had a negative mammographic screen in the past 2 months
  • No personal history of breast cancer

Exclusion Criteria:

-


Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Grant, MPH 9196135953 jennifer.grant@duke.edu

Locations
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United States, North Carolina
Duke Mammography Clinic Recruiting
Durham, North Carolina, United States, 27710
Contact: Jennifer Grant, MPH    919-613-5953    jennifer.grant@duke.edu   
Principal Investigator: Marc Ryser, PhD         
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Marc D Ryser, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03775213    
Other Study ID Numbers: Pro00101109
4R00CA207872-03 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Ductal carcinoma in situ
Decision support tool
Informed decision-making
Overtreatment
Active surveillance
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ