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

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 30, 2026 to May 1, 2027
    • Site details revised at 2 of 2 sites
    v7
  2. Minor Eligibility criteria revisedv6
  3. Minor Secondary endpoints: 17 to 15v5
  4. Minor Eligibility criteria shortened, about 10 wordsv4
  5. Minor Site contacts updated at 1 of 2 sitesv3
  6. Minor Start date changed from estimate of Jan 21, 2023 to Jan 19, 2023
    • Study title revised
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05703178
Lead Sponsor Northwestern University
Collaborators: Duke University, National Cancer Institute (NCI)
Conditions
(from sponsor)
Breast Cancer, Arthralgia, Pain, Chronic
Related terms Arthralgia, Breast Neoplasms, Chronic Pain
Enrollment 452 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov