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

Launched by NORTHWESTERN UNIVERSITY · Jan 19, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether an online program that teaches pain coping skills can help women who have been treated for stage I-III breast cancer and are experiencing joint pain from hormone therapy medications called aromatase inhibitors (AIs). The study aims to find out if this training can reduce pain, improve daily life, enhance emotional well-being, and help women stick to their medication schedules. It will also look at whether the training can ease sleep problems and menopausal symptoms, like hot flashes.

To participate, women need to be at least 18 years old, have completed their primary cancer treatment, and currently be taking an AI medication while experiencing significant joint pain. Participants will complete questionnaires over about 9 to 10 months and attend a few virtual meetings. They will be randomly assigned to either receive information about AIs and joint pain or receive this information plus access to the online training. This study can be done from home, making it convenient for those who might want to join.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female sex
• • Aged 18 years old or older
• • Diagnosed with Stage I-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)