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Well-Being ABCs (Well-Being After Breast Surgery) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test a skills training program that is designed to help people cope with pain. We want to know if this program can help people manage pain after breast surgery.

This is important because studies show that between 25% and 60% of people who have breast surgery for cancer or other medical conditions report having persistent pain afterward.

What is the Condition Being Studied?

People with persistent pain after breast surgery

Who Can Participate in the Study?

Adults age 18 and older who:

  • Were diagnosed with Stage 0 to III breast cancer
  • Had their first surgery (total or partial mastectomy or lumpectomy) for breast cancer, DCIS, or LCIS at least 3 months ago
  • Had pain in the area of their breast surgery in the past month

For more information about who can be in this study, please contact the study team at 919-681-8437 or Michael.W.Willis@duke.edu.

Age Group
Adults

What is Involved?

This study compares three different programs that aim to improve well-being after breast surgery:

  • The first program focuses on providing you with coping strategies and improving your well-being with the help of a coach
  • The second program focuses on providing you with healthy lifestyle information and strategies with the help of a coach
  • The third program focuses on providing you with healthy lifestyle information and strategies through a self-guided workbook

If you choose to join the study, you will:

  • Be randomly assigned (like drawing numbers from a hat) to one of the three programs
  • Have 8 video meetings, if you are in one of the programs with a coach
  • Answer questionnaires
  • Come to our clinic for 3 visits over the course of about 12 months
  • Perform physical function tests (like grip strength) and a short sensory test during the clinic visits
    •

    Study Details

    Full Title
    Improving Well-Being for Individuals with Persistent Pain after Surgery for Breast Cancer, Lobular Carcinoma in Situ, or Ductal Carcinoma in Situ: A Randomized Clinical Trial that Compares Three Behavioral Intervention Strategies and Examines Psychological Factors as Drivers of the Continuing Burden of Persistent Pain
    Principal Investigator
    Rebecca Shelby
    Protocol Number
    IRB: PRO00104214
    NCT: NCT04225585
    ClinicalTrials.gov
    Enrollment Status
    Open for Enrollment
    Participate
    Contact the Duke Recruitment Innovation Center
    MyResearchPartners@duke.edu
    or
    919-681-5698

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