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.
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.
Who Can Participate?
Eligibility
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.
- 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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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
- 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
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Study Website
Principal Investigator
Rebecca
Shelby
Protocol Number
PRO00104214
NCT ID
NCT04225585
Enrollment Status
OPEN TO ACCRUAL