Clinical Trial

Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia

Active, Not Recruiting Phase 3
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Summary
The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main questions it aims to answer are: 1. Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives. 2. Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications. 3. Whether benefits of online pain coping skills training are at least partially caused by women's increased confidence that they can manage their pain and a reduction in unhelpful thinking patterns about pain. 4. Whether online pain coping skills training improves effects of AI medications on sleep problems and symptoms of menopause like hot flashes and night sweats. Participants can complete all parts of the study at home. They will: 1. Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months. 2. Attend 3 meetings in the first month of the study, all of which can be held via a video conference. 3. Use an electronic pill bottle to track their use of their AI medication. 4. Be randomized (like flipping a coin) to one of two study arms: They will either receive education about AIs and arthralgia or they will receive this education along with access to an online pain coping skills training program. Research will compare the education group to the education plus online pain coping skills training group to see if online pain coping skills training has the benefits mentioned above.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-01-19; most recent amendment 2026-07-07.
Status change: Recruiting → Active, Not Recruiting 2026-07-07
Trial Details
NCT Number NCT05703178
Lead Sponsor Northwestern University
Collaborators: Duke University, National Cancer Institute (NCI)
Conditions Breast Cancer, Arthralgia, Pain, Chronic
Enrollment 452 participants
Start Date 2023-01-19
Primary Completion 2026-11-30 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-08