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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05703178
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Online Pain Coping Skills Training — BEHAVIORAL
    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.
  • Education — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 19, 2023
Status verified
Jul 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
452 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Education + Online Pain Coping Skill Training
    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. They will also be given access to an online pain coping skills training program and asked to complete it at home over 8 to 10 weeks. This interactive, web-based program teaches cognitive and behavioral skills that research has shown can reduce pain and pain-related interference with daily activities. The program includes eight sessions that participants will complete at a rate of about 1 per week. Each session takes 35-45 minutes. Participants will be shown how to use the program and can contact the study team if they have any problems with it. Participants who do not have a device capable of accessing the program will be loaned a tablet computer for the study.
  • Active Comparator: 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.

Primary Outcome Measure

Change in Brief Pain Inventory pain severity subscale [ Time Frame: Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Christine Rini, PhD
[email protected]
312-503-7715
Zahra Hosseinian
[email protected]
Duke UniversityDurhamNorth Carolina27708
Tamara Somers
[email protected]
919-416-3408
Shannon Miller
[email protected]

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Northwestern University· Chicago, ILDuke University· Durham, NC

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