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

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.

Conditions

• Breast Cancer
• Arthralgia
• Pain, Chronic

Interventions

OTHER

Education

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.

BEHAVIORAL

Online 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.

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Northwestern University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-19

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• United States

Study Locations