RecruitingPhase 3NCT05703178

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

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


Sponsor

Northwestern University

Enrollment

452 participants

Start Date

Jan 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an online pain coping skills program for women with breast cancer who are experiencing joint and muscle pain caused by hormone-blocking medications called aromatase inhibitors (like letrozole, anastrozole, or exemestane), which are commonly used after breast cancer treatment. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with Stage 0–III hormone receptor-positive breast cancer - You have completed primary treatment (surgery, chemo, and/or radiation) - You are postmenopausal and currently taking an aromatase inhibitor - You have developed or worsened joint/muscle pain since starting the medication - You have had pain on at least 15 days in the past month, with a severity of 4 or higher out of 10 - You are comfortable using a tablet, computer, or smartphone **You may NOT be eligible if...** - Your cancer has spread (metastatic disease) - You have another active cancer - You finished chemotherapy or radiation fewer than 4 weeks ago - You do not speak English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(2)

Northwestern University

Chicago, Illinois, United States

Duke University

Durham, North Carolina, United States

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NCT05703178


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