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Pain Coping Skills Training to Improve Pain and Poor Adherence caused by Aromatase Inhibitory-Associated Arthralgia in Breast Cancer Survivors, SKIP-Arthralgia Trial
Trial Status: active
This clinical trial evaluates the effect of an online pain coping skills training program (painTRAINER) in combination with enhanced usual care, compared to enhanced usual care alone, for improving pain and poor treatment adherence caused by aromatase inhibitors. Aromatase inhibitors are a medicine that women take to reduce their chance of having breast cancer again after they finish their breast cancer treatment. However, they also cause significant side effects. The most frequently-reported side effect is arthralgia, which is musculoskeletal pain and stiffness. Arthralgia interferes with completion of daily tasks, reduces health-related quality of life, and increases emotional distress. It is also the side effect most strongly associated with aromatase inhibitor discontinuation (poor adherence). Pain coping skills training teaches patients cognitive and behavioral skills (e.g., relaxation, cognitive reappraisal, activity pacing) for managing pain and its effects on physical function. The information gained from this trial may help researchers evaluate whether the online painTRAINER program with enhanced usual care can improve painful arthralgia and related patient outcomes in breast cancer survivors taking aromatase inhibitors and whether reducing arthralgia can, in turn, also improve aromatase inhibitor adherence as compared to enhanced usual care alone.
Inclusion Criteria
Female
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
Aged 18 years or older
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
Diagnosed with stage I-III hormone receptor positive (HR+) breast cancer
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
Completed primary cancer treatment (surgery, chemotherapy, and/or radiation therapy)
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
* The indicated eligibility criterion may change over time, meaning that women who are not eligible at a given timepoint may become eligible later. When women are excluded based on one or more of these criteria, we will ask for their consent to recontact them for later potential enrollment
Currently taking AI therapy (letrozole, exemestane, or anastrozole)
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
* For determining eligibility, these data will be verified in screening interview (self-report)
Reporting musculoskeletal pain that developed or worsened since starting AI therapy
* For determining eligibility, these data will be verified in screening interview (self-report)
Reporting at least 15 days of pain in the past 30 days
* For determining eligibility, these data will be verified in screening interview (self-report)
* The indicated eligibility criterion may change over time, meaning that women who are not eligible at a given timepoint may become eligible later. When women are excluded based on one or more of these criteria, we will ask for their consent to recontact them for later potential enrollment
A worst pain rating of 4 or more on an 11 point (0-10) numerical rating scale in the past week
* For determining eligibility, these data will be verified in screening interview (self-report)
* The indicated eligibility criterion may change over time, meaning that women who are not eligible at a given timepoint may become eligible later. When women are excluded based on one or more of these criteria, we will ask for their consent to recontact them for later potential enrollment
Based on known factors affecting their prognosis, patient is likely to be able to complete the study protocol
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
English proficient
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
* For determining eligibility, these data will be verified in screening interview (self-report)
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)
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
* For determining eligibility, these data will be verified in screening interview (self-report)
* The indicated eligibility criterion may change over time, meaning that women who are not eligible at a given timepoint may become eligible later. When women are excluded based on one or more of these criteria, we will ask for their consent to recontact them for later potential enrollment
Comfortable using a tablet computer, a computer, or a smartphone to access online training
* For determining eligibility, these data will be verified in screening interview (self-report)
Exclusion Criteria
Evidence of metastatic disease
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
Other active cancer (with the exception of non-melanoma skin cancer)
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
* For determining eligibility, these data will be verified in screening interview (self-report)
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)
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
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
* For determining eligibility, these data will be verified in screening interview (self-report)
* The indicated eligibility criterion may change over time, meaning that women who are not eligible at a given timepoint may become eligible later. When women are excluded based on one or more of these criteria, we will ask for their consent to recontact them for later potential enrollment
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)
* For determining eligibility, these data will be ascertained with medical records (and, when appropriate, verification of treating clinician)
* For determining eligibility, these data will be verified in screening interview (self-report)
Additional locations may be listed on ClinicalTrials.gov for NCT05703178.
I. Determine whether painTRAINER reduces pain severity and pain interference at the post-intervention follow-up assessment (follow-up [FU]1; primary outcomes/endpoint) as well as at the 3-month and 6-month follow-up assessments (FU2 and FU3).
II. Determine whether painTRAINER improves emotional distress, health-related quality of life (HRQoL), and aromatase inhibitor (AI) adherence at the post-intervention, 3-month, and 6-month follow-up assessments (FU1, FU2, and FU3; secondary outcomes).
III. Determine whether effects of painTRAINER on primary and secondary outcomes are at least partially mediated by increases in pain self-efficacy and reductions in pain catastrophizing.
EXPLORATORY OBJECTIVE:
I. Explore indirect benefits of painTRAINER on other common AI adverse effects—sleep disturbance and vasomotor symptoms (hot flushes, hot flashes, night sweats).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ENHANCED USUAL CARE): Patients receive printed educational materials about AI therapy, arthralgia, and other AI symptoms at the baseline visit and receive usual care for 8-10 weeks.
ARM II (PAINTRAINER): Patients receive care as in arm I as well as complete the painTRAINER program consisting of eight weekly virtual, self-guided sessions over 35-45 minutes each for 8-10 weeks.
After completion of study intervention, patients are followed up at 12, 24, and 36 weeks after randomization.
