Actively Recruiting
Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence Caused by Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors
Led by Northwestern University · Updated on 2025-07-25
452
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the benefits of an online pain coping skills training program for women diagnosed with stage I-III breast cancer who have completed their primary treatment, are taking aromatase inhibitor (AI) medication, and experience arthralgia. Arthralgia, a common side effect of AI medications, causes joint, bone, and muscle pain. The study seeks to determine if this online program can reduce pain severity and interference, improve emotional distress, quality of life, and medication adherence, and positively affect sleep problems and menopause symptoms such as hot flashes and night sweats. Participants will be randomly assigned to one of two groups: one receiving education about AIs and arthralgia alone, and the other receiving this education plus access to the online pain coping skills training. The training consists of eight interactive sessions completed weekly over 8 to 10 weeks, each lasting 35 to 45 minutes. Participants will continue their usual medical care and receive an educational booklet. Those without a device to access the program may be loaned a tablet computer. During the study, participants will complete four sets of questionnaires over about 9 to 10 months and attend three video conference meetings in the first month. Their AI medication use will be tracked using an electronic pill bottle. Researchers will measure changes in pain severity and interference, emotional distress, quality of life, medication adherence, and related symptoms. The main outcomes focus on changes in pain severity and interference within 10 to 14 weeks after starting the study.
CONDITIONS
Brief Title
Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Likely to be able to complete the study protocol based on known prognosis factors
- ECOG performance status of 0-2
- English proficient
- If taking analgesics, must be on a stable dose for at least 14 days prior to enrollment with no planned increases during the study
- Comfortable using a tablet, computer, or smartphone to access online training
You will not qualify if you...
- Evidence of metastatic disease
- Other active cancer except non-melanoma skin cancer
- Completed chemotherapy or radiation therapy less than four weeks before enrollment
- Completed surgery less than 8 weeks before enrollment (minor surgeries may be exceptions)
- Diagnosed or suspected condition that would interfere with consent or study completion such as significant cognitive impairment or uncorrected hearing/vision problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 10 weeks
Participants complete an online pain coping skills training program at home over 8 to 10 weeks, which includes eight interactive sessions teaching different pain coping skills. Participants are also given an educational booklet about Aromatase Inhibitors and managing arthralgia. Sessions take about 35 to 45 minutes each and participants can review them anytime.
Approximately 8 online sessions completed at home
Duration - 8 to 10 weeks
Participants receive usual medical care and an educational booklet about Aromatase Inhibitors and managing arthralgia without access to the online training program.
No additional visits beyond routine care
Duration - Up to 34 to 38 weeks post-baseline
Participants are followed for ongoing assessments of pain, adherence, mood, and quality of life up to 34 to 38 weeks post-baseline.
3 follow-up assessments at 10-14 weeks, 22-26 weeks, and 34-38 weeks post-baseline
Trial Site Locations
Total: 2 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
Research Team
C
Christine Rini, PhD
Z
Zahra Hosseinian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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