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
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Northwestern University
- Enrollment
- 452
- Locations
- 2
- Primary Endpoint
- Change in Brief Pain Inventory pain severity subscale
Study Overview
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:
- Whether online pain coping skills training reduces the severity of pain and the interference it causes in women's daily lives.
- Whether online pain coping skills training improves emotional distress, quality of life, and adherence to AI medications.
- 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.
- 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:
- Complete four sets of questionnaires throughout the study, which will take about 9 to 10 months.
- Attend 3 meetings in the first month of the study, all of which can be held via a video conference.
- Use an electronic pill bottle to track their use of their AI medication.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Online Pain Coping Skills Training (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: Education (Other)
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.
Intervention: Education (Other)
Outcomes
Primary Outcomes
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)
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 Brief Pain Inventory pain interference subscale
Time Frame: Change in BPI pain interference from baseline to 10-14 weeks post-baseline (Follow up 1)
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.
Secondary Outcomes
- 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 Functional Assessment of Cancer Therapy-Lymphedema (FACT-B)(Change in FACT-B total 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 34-38 weeks post-baseline (Follow up 3))
- Probability of optimal adherence using event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)(Probability of MEMS-recorded optimal adherence from baseline to 10-14 weeks post-baseline (Follow up 3))
- Change in Medication Adherence Rating Scale(Change in MARS scores from baseline to 34-38 weeks post-baseline (Follow up 3))
- Change in Use event data from electronic pill bottle (Medication Event Monitoring System or MEMS Cap pill bottles)(Change in MEMS-recorded adherence from baseline to 10-14 weeks post-baseline (Follow up 1))
- 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))
Investigators
Christine Rini, PhD
Professor
Northwestern University