RecruitingPhase 3

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

United States452 participantsStarted 2023-01-19

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female sex * Aged 18 years old or older * Diagnosed with Stage 0-III hormone receptor positive breast cancer * Completed primary cancer treatment (surgery, chemotherapy, and/or radiation therapy) * Postmenopausal * Currently taking AI therapy (letrozole, exemestane, or anastrozole) * Reporting musculoskeletal pain that developed or worsened since starting AI therapy * Reporting at least 15 days of pain in the past 30 days * A worst pain rating of 4 or more on an 11 point (0-10) numerical rating scale in the past week * Based on known factors affecting their prognosis, patient is likely to be able to complete the study protocol * ECOG performance status of 0-2 * English proficient * If participants are taking analgesics, they must be on a stable analgesic regimen for at least 14 days prior to enrollment and should not have planned upward dose titration of their analgesics during the study period. (Note: Patients may elect to decrease their analgesic use during the study as per discussion with their provider. Unexpected dose adjustments including dose escalations due to unforeseen clinical need is allowed. Cannabis taken for pain relief would qualify as an analgesic) * Comfortable using a tablet computer, a computer, or a smartphone to access online training Exclusion Criteria: * Evidence of metastatic disease * Other active cancer (with the exception of non-melanoma skin cancer) * Completed chemotherapy or radiation therapy less than four weeks prior t…

What they're measuring

Change in Brief Pain Inventory pain severity subscale

Timeframe: Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)

Change in Brief Pain Inventory pain interference subscale

Timeframe: Change in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)

Trial details

NCT IDNCT05703178

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Christine Rini, PhD

312-503-7715 christine.rini@northwestern.edu

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