R01CA271220

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

Aromatase inhibitors (AIs) are standard post-treatment care for postmenopausal breast cancer survivors (BCS) with hormone-receptor positive (HR+) tumors. AIs improve survival and reduce the risk for cancer recurrence, but they also cause significant adverse effects. The most common adverse effect is arthralgia, which is joint pain and stiffness that affects about 50% of BCS soon after starting an AI. Painful arthralgia causes emotional distress and poor health-related quality of life (HRQOL). It is also the AI side effect most strongly linked to adherence problems, which are a critical medical concern.

Current medical and behavioral interventions for managing painful arthralgia help only a minority of BCS, cause toxicities that limit their use, or have weak evidence, revealing a critical gap limiting the ability to reduce the impact of painful arthralgia on BCS using AIs. We propose to fill this critical gap with pain coping skills training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention. To our knowledge, no study has evaluated PCST for the management of AI-associated painful arthralgia, although randomized controlled trials (RCTs) show that PCST and similar interventions delivered by trained therapists can improve pain and reduce disability in people with cancer, chronic musculoskeletal pain, and other pain conditions.

Despite its efficacy, PCST continues to be underused in clinical care due to barriers such as high resource costs, lack of availability in some geographic areas, travel requirements for patients, and a shortage of trained therapists. We have developed a web-based PCST program called PainTrainer to overcome these barriers, using a novel approach to optimize engagement and retain therapeutically critical features of therapist-delivered PCST in an "automated" program that does not require therapist involvement. PainTrainer mimics highly interactive and personalized therapist-delivered PCST. RCT evidence shows that PainTrainer is highly acceptable and engaging, and that it can reduce joint pain and stiffness in people with osteoarthritis (OA). We now seek to evaluate whether it can improve the severity of painful arthralgia and its associated interference and other adverse impacts on BCS on AI therapy.

The proposed multi-site RCT will randomize 452 BCS with AI-associated painful arthralgia to enhanced usual care (EUC) or PainTrainer+EUC. Assessments will occur at baseline, post-intervention (12 weeks after baseline), and 3- and 6-months post-intervention. The aims are to determine whether PainTrainer+EUC, compared to EUC, improves pain severity and pain interference (Aim 1, primary outcomes) as well as distress, HRQOL, and AI adherence (Aim 2, secondary outcomes). We will also determine whether these effects on primary and secondary outcomes are at least partially mediated by increases in pain self-efficacy and reductions in pain catastrophizing (Aim 3). Finally, for an exploratory aim, we will evaluate beneficial indirect effects on sleep problems and vasomotor symptoms in addition to gathering participant feedback on PainTrainer's fit for their unique needs.

This RCT could yield a highly disseminable intervention that could be quickly implemented clinically, including in geographic areas with limited access to PCST.

Northwestern University

NOT APPLICABLE

93.395 - Cancer Treatment Research

National Cancer Institute (NCI) [HHS - NIH]

Chicago, Illinois 606113180 United States

Single Zip Code

Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) (PAR-21-035)

Amendment Since initial award the total obligations have increased 382% from $653,640 to $3,151,824.