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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05703178
Study type	Interventional
Source	Northwestern University
Contact	Christine Rini, PhD
Phone	312-503-7715
Email	christine.rini@northwestern.edu
Status	Recruiting
Phase	Phase 3
Start date	January 19, 2023
Completion date	November 30, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms