Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT05703178

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

Led by Northwestern University · Updated on 2025-07-25

452

Participants Needed

2

Research Sites

201 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

D

Duke University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Age 18 years 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)
  • Experiencing musculoskeletal pain that developed or worsened since starting AI therapy
  • Reporting pain on at least 15 days in the past 30 days
  • Having a worst pain rating of 4 or higher on a 0-10 scale in the past week
  • Likely able to complete the study protocol based on prognosis factors
  • ECOG performance status of 0-2
  • Proficient in English
  • If using analgesics, must be on a stable regimen for at least 14 days before enrollment without planned dose increases during the study (dose decreases allowed; cannabis counts as analgesic)
  • Comfortable using a tablet, computer, or smartphone to access online training
Not Eligible

You will not qualify if you...

  • Evidence of metastatic disease
  • Having another active cancer except non-melanoma skin cancer
  • Completed chemotherapy or radiation less than 4 weeks before enrollment
  • Completed surgery less than 8 weeks before enrollment (minor surgeries may be allowed more recently at study team's discretion)
  • Diagnosed or suspected condition interfering with informed consent or study completion such as significant cognitive impairment or uncorrected hearing or vision problems

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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

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Research Team

C

Christine Rini, PhD

CONTACT

Z

Zahra Hosseinian

CONTACT

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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