NCT05703178

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Northwestern University
~452 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Online Pain Coping Skills TrainingEducation

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Brief Pain Inventory pain severity subscale
Measured over Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)
+1 more outcome measured
Breast Cancer
Arthralgia
Pain, Chronic
2 sites across 2 states
Illinois1
North Carolina1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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 to enrollment (these treatments can cause temporary exacerbation of musculoskeletal symptoms that typically resolve spontaneously)
Completed surgery less than 8 weeks prior to enrollment (because surgery can cause temporary post-surgical pain that typically resolves in this period of time); minor surgeries may be allowed more recently than 8 weeks at the discretion of the study team
Have diagnosed or suspected condition that would interfere with informed consent or completion of study activities (e.g., significant impairment in cognition or uncorrected hearing/vision)
  • Change in Brief Pain Inventory pain severity subscaleChange in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)

    We will calculate the mean of the four items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate more severe pain. Analyses will examine group differences in change in pain severity.

  • Change in Brief Pain Inventory pain interference subscaleChange in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)

    We will calculate the mean of the seven items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate greater interference. Analyses will examine group differences in change in pain interference.