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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Arthralgia Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Online Pain Coping Skills Training

Intervention Type 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

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Education

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No