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RecruitingInterventionalPhase 3

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

NCT ID: NCT05703178Sponsor: Northwestern UniversityLast updated: 2025-07-25

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.

Arms & interventions

  • BehavioralOnline Pain Coping Skills Training

    The intervention is completed online, using a personal computer, tablet computer, or smartphone. It includes 8 interactive sessions, each of which teaches users a different pain coping skill. Participants are asked to practice these skills in their daily lives to manage pain and pain-related symptoms and problems. Each session takes 35 to 45 minutes to complete. Participants can take breaks during the sessions and review them at any time after completing them.

  • OtherEducation

    Participants will receive their usual medical care and an educational booklet with information about Aromatase Inhibitors (AIs), side effects they cause including painful arthralgia, methods for managing arthralgia, and tips for talking with doctors about arthralgia and other AI side effects.

Outcome measures

Primary

  • Change in Brief Pain Inventory pain severity subscale

    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.

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

  • Change in Brief Pain Inventory pain interference subscale

    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.

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

Secondary

  • Change in Brief Pain Inventory pain severity subscale

    Time frame: Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)

  • Change in Brief Pain Inventory pain severity subscale

    Time frame: Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)

  • Change in Brief Pain Inventory pain interference subscale

    Time frame: Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)

  • Change in Brief Pain Inventory pain interference subscale

    Time frame: Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)

  • Change in Hospital Anxiety and Depression Scale

    Time frame: Change in HADS score from baseline to 10-14 weeks post-baseline (Follow up 1)

  • Change in Hospital Anxiety and Depression Scale

    Time frame: Change in HADS score from baseline to 22-26 weeks post-baseline (Follow up 2)

  • Change in Hospital Anxiety and Depression Scale

    Time frame: Change in HADS score from baseline to 34-38 weeks post-baseline (Follow up 3)

  • Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)

    Time frame: Change in FACT-B total score from baseline to 10-14 weeks post-baseline (Follow up 1)

  • Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)

    Time frame: Change in FACT-B total score from baseline to 22-26 weeks post-baseline (Follow up 2)

  • Change in Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)

    Time frame: Change in FACT-B total score from baseline to 34-38 weeks post-baseline (Follow up 3)

  • Change in Medication Adherence Rating Scale

    Time frame: Change in MARS scores from baseline to 10-14 weeks post-baseline (Follow up 1)

  • Change in Medication Adherence Rating Scale

    Time frame: Change in MARS scores from baseline to 22-26 weeks post-baseline (Follow up 2)

  • Change in Medication Adherence Rating Scale

    Time frame: Change in MARS scores from baseline to 34-38 weeks post-baseline (Follow up 3)

  • Change in Use event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)

    Time frame: Change in MEMS-recorded adherence from baseline to 10-14 weeks post-baseline (Follow up 1)

  • Probability of optimal adherence using event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)

    Time frame: Probability of MEMS-recorded optimal adherence from baseline to 10-14 weeks post-baseline (Follow up 3)

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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)

Study locations (2)

Northwestern University

Chicago, Illinois, 60611

Recruiting
Christine Rini, PhD · Contact
312-503-7715christine.rini@northwestern.edu
Zahra Hosseinian · Contact
zahra.hosseinian@northwestern.edu

Duke University

Durham, North Carolina, 27708

Recruiting
Tamara Somers · Contact
919-416-3408tamara.somers@duke.edu
Shannon Miller · Contact
shannon.n.miller@duke.edu

References

  • Hosseinian Z, Lehan A, Powers JM, Melendez A, Fisher HM, Shelby R, Somers T, Keefe F, Paice J, Kimmick G, Burns J, Flores AM, Fox RS, Kaiser K, Farrell D, Westbrook K, Rini C. Web-Based Pain Coping Skills Training (PCST) for Managing Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors: Randomized Controlled Trial Protocol. Contemp Clin Trials. 2025 Feb;149:107780. doi: 10.1016/j.cct.2024.107780. Epub 2024 Dec 18.(PubMed)
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia | Cancerify