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

NCT05703178 | Recruiting Phase 3 DMC

• 1 other identifier: STU00216520
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 2

Brief 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. 1.Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives.
2. 2.Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications.
3. 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. 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.
5. 5.Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months.
6. 6.Attend 3 meetings in the first month of the study, all of which can be held via a video conference.
7. 7.Use an electronic pill bottle to track their use of their AI medication.
8. 8.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.

Conditions

Breast Cancer; Arthralgia; Pain, Chronic

Keywords

Breast Cancer, Arthralgia, Aromatase Inhibitors, Pain Coping Skills Training, Cognitive Behavioral Therapy, Non-Pharmacologic Pain Treatments

Outcome Measures

Primary Outcomes (2)

• Change in Brief Pain Inventory pain severity subscale

  We will calculate the mean of the four items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate more severe pain. Analyses will examine group differences in change in pain severity.

  Change in BPI pain severity from baseline to 10-14 weeks post-baseline (Follow up 1)

• Change in Brief Pain Inventory pain interference subscale

  We will calculate the mean of the seven items on this subscale, as recommended by the scale's developers, to yield a score ranging from 0 to 10; higher scores indicate greater interference. Analyses will examine group differences in change in pain interference.

  Change in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)

Secondary Outcomes (15)

• Change in Brief Pain Inventory pain severity subscale

  Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)

• Change in Brief Pain Inventory pain severity subscale

  Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)

• Change in Brief Pain Inventory pain interference subscale

  Change in BPI pain severity score from baseline to 22-26 weeks post-baseline (Follow up 2)

• Change in Brief Pain Inventory pain interference subscale

  Change in BPI pain severity score from baseline to 34-38 weeks post-baseline (Follow up 3)

• Change in Hospital Anxiety and Depression Scale

  Change in HADS score from baseline to 10-14 weeks post-baseline (Follow up 1)

Other Outcomes (15)

• Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale

  Change in Self-efficacy for pain management from baseline to 10-14 weeks post-baseline (Follow up 1)

• Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale

  Change in Self-efficacy for pain management from baseline to 22-26 weeks post-baseline (Follow up 2)

• Change in Chronic Pain Self-Efficacy Scale Pain Management Subscale

  Change in Self-efficacy for pain management from baseline to 34-38 weeks post-baseline (Follow up 3)

Study Arms (2)

Education + Online Pain Coping Skill Training

EXPERIMENTAL

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.

Behavioral: Online Pain Coping Skills Training; Other: Education

Education

ACTIVE COMPARATOR

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.

Other: Education

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 + Online Pain Coping Skill Training

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.

Education; Education + Online Pain Coping Skill Training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex
• Aged 18 years old 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)
• Reporting musculoskeletal pain that developed or worsened since starting AI therapy
• Reporting at least 15 days of pain in the past 30 days
• A worst pain rating of 4 or more on an 11 point (0-10) numerical rating scale in the past week
• Based on known factors affecting their prognosis, patient is likely to be able to complete the study protocol
• ECOG performance status of 0-2
• English proficient
• If participants are taking analgesics, they must be on a stable analgesic regimen for at least 14 days prior to enrollment and should not have planned upward dose titration of their analgesics during the study period. (Note: Patients may elect to decrease their analgesic use during the study as per discussion with their provider. Unexpected dose adjustments including dose escalations due to unforeseen clinical need is allowed. Cannabis taken for pain relief would qualify as an analgesic)
• Comfortable using a tablet computer, a computer, or a smartphone to access online training

You may not qualify if:

• Evidence of metastatic disease
• Other active cancer (with the exception of non-melanoma skin cancer)
• Completed chemotherapy or radiation therapy less than four weeks prior to enrollment (these treatments can cause temporary exacerbation of musculoskeletal symptoms that typically resolve spontaneously)
• Completed surgery less than 8 weeks prior to enrollment (because surgery can cause temporary post-surgical pain that typically resolves in this period of time); minor surgeries may be allowed more recently than 8 weeks at the discretion of the study team
• Have diagnosed or suspected condition that would interfere with informed consent or completion of study activities (e.g., significant impairment in cognition or uncorrected hearing/vision)

Sponsors & Collaborators

• Northwestern University: lead
• Duke University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia; Chronic Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Christine Rini, PhD

CONTACT

312-503-7715; christine.rini@northwestern.edu

Zahra Hosseinian

CONTACT

Zahra.Hosseinian@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 27, 2023
• Study Start: January 19, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)