Neoplasms

Skin and Connective Tissue Diseases

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Symptoms and General Pathology

Musculoskeletal Diseases

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Pain

Arthralgia

Chronic Pain

Breast Diseases

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Neurologic Manifestations

Joint Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Aromatase Inhibitors

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.

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.

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.

Online Pain Coping Skills Training

Education

Christine Rini, PhD

Zahra Hosseinian

Tamara Somers

Shannon Miller

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.

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

Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence Caused by Aromatase Inhibitor-Associated Arthralgia In Breast Cancer Survivors (SKIP-Arthralgia): A Randomized Controlled Trial

Data will be shared according to the most recent NIH guidelines for sharing research data (https://grants.nih.gov/grants/policy/data_sharing/). Findings will be disseminated through presentations at national scientific meetings and peer-reviewed manuscripts. We will make our data available for review and/or research to qualified individuals after the main findings from the final dataset are accepted for publication. Individuals requesting data will be asked to describe their goals, data needs and planned analyses including statistical power. Requests will be reviewed by a Data Access Committee made up of the project's key personnel. This committee will evaluate scientific validity, statistical power, overlap with other analyses/publications, and ethical aspects of the proposed use of the data. We will protect the rights and privacy of our study participants by de-identifying the data and taking any other steps necessary to eliminate potential deductive disclosure.

Using standard scoring procedures, we will calculate the mean of responses to this subscale's 5 items to yield a total score ranging from 10-100, where higher scores indicate greater self-efficacy for managing chronic pain. Analyses will examine change in pain self-efficacy.

Using standard scoring methods, we will sum responses for the 13 items on this scale to yield a score ranging from 0-52, where higher scores indicate greater pain catastrophizing. Analyses will examine change in pain catastrophizing from baseline; change from baseline to post-intervention (follow up 1) will also be examined as a potential mediator of changes in pain severity and interference.

Using standard scoring methods, we will sum responses for the 13 items on this scale to yield a score ranging from 0-52, where higher scores indicate greater pain catastrophizing. Analyses will examine change in pain catastrophizing.

Using standard scoring procedures for this scale, we will sum responses and calculate T-scores that rescale raw scores into a standardized score with a mean of 50 and a standard deviation of 10; higher scores indicate greater sleep disturbance. Analyses will examine group differences in change in sleep disturbance.

Using standard scoring procedures for this scale, we will sum responses and calculate T-scores that rescale raw scores into a standardized score with a mean of 50 and a standard deviation of 10; higher scores indicate greater sleep-related impairment. Analyses will examine group differences in change in sleep-related impairment.

Using standard scoring procedures for the 3-item vasomotor subscale, we will calculate the mean of responses to yield a score ranging from 1 to 8; higher scores indicated higher vasomotor symptoms. Analyses will examine change in vasomotor symptoms.

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.

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.

We will reverse score items as necessary, and then sum responses to the measure's 14 items to yield a total score ranging from 0 to 42; higher scores indicate greater emotional distress. Analyses will examine group differences in change in emotional distress.

We will use the total score for the FACT-B, normalizing scores according to standard scoring methods to yield a score from 0-100; higher scores indicate greater Health-Related Quality of Life (HRQoL). Analyses will examine group differences in change in HRQoL.

Using standard scoring instructions, we will first rescore each of the 10 items on this scale to indicate adherence (=1) or non-adherence (=0), then sum them to yield a score from 0 to 10; higher scores indicate better self-reported medication adherence. Analyses will examine group differences in change in adherence.

We will use data from these pill bottles, gathered daily throughout the study, to compute an adherence score (percentage of days on which the prescribed dose of medication was taken) and evaluate group differences in change in adherence from baseline to each of the post-intervention assessments.

We will use data from these pill bottles, gathered daily throughout the study, to compute an adherence score (percentage of days on which the prescribed dose of medication was taken) and evaluate group differences in probability of optimal adherence, using a dichotomous variable using a cutoff of \<80% to identify sub-optimal adherence (where 80% or greater adherence is optimal).

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