Online pain coping skills training for breast cancer survivors with joint pain
Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence Caused by Aromatase Inhibitor-Associated Arthralgia In Breast Cancer Survivors (SKIP-Arthralgia): A Randomized Controlled Trial
This study is testing an online program to help women with breast cancer who have joint pain from their treatment learn skills to manage their pain and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 452 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05703178 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an online pain coping skills training program for women diagnosed with stage I-III breast cancer who are experiencing joint pain due to aromatase inhibitor medications. The study will assess whether this training can reduce pain severity, improve emotional well-being, enhance quality of life, and increase adherence to medication. Participants will engage in cognitive behavioral therapy techniques to help manage their pain and improve their confidence in coping with it. The trial will also explore the impact of this training on sleep issues related to medication side effects.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 18 and older with stage I-III hormone receptor positive breast cancer who are currently taking aromatase inhibitors and experiencing significant musculoskeletal pain.
Not a fit: Patients who are not postmenopausal, have not completed primary cancer treatment, or do not report significant pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve pain management and quality of life for breast cancer survivors experiencing joint pain.
How similar studies have performed: Other studies have shown promise in using cognitive behavioral therapy and pain coping strategies for chronic pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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)
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Christine Rini, PhD
- Email: christine.rini@northwestern.edu
- Phone: 312-503-7715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.