Administrative supplement to: “Implementing and evaluating mHealth pain coping skills training interventions to improve self-management of chronic pain in cancer survivors in “real world” clinical practice settings: 3UG1CA189824-06
ABSTRACT Pain is one of the most common symptoms reported among cancer survivors, and yet it often remains inadequately treated. Persistent and poorly managed pain is commonplace among cancer treatment survivors. Treatment guidelines state patients should have access to pain coping skills training (PCST) interventions that teach patients cognitive and behavioral coping skills to reduce pain and pain interference and enhance quality of life. When delivered in-person, PCST can improve pain and functioning in people with cancer, and yet, these interventions are underused in clinical care due to barriers such as high resource costs, shortage of trained therapists, travel requirements, and costs of clinic visits. To address barriers, we developed a web-based PCST program using an expert systems approach designed to retain therapeutically critical features of in-person PCST that does not require therapist involvement. This program (painTRAINER) mimics in-person PCST via tailoring algorithms and a knowledge database that applies our team’s specialized training and experience in delivering PCST. The parent trial is evaluating whether painTRAINER is effective for self-management of cancer-related persistent pain among cancer survivors who have completed treatment as compared to usual medical care. The trial will be conducted at community sites across the country through the NCI’s National Community Oncology Research Program (NCORP). IMPACTS is in its Year 1 (UG3) milestone-driven planning phase and in preparation for transition to the trial implementation phase (UH3). The IMPACTS study entails a pragmatic, randomized controlled clinical trial to determine whether painTRAINER plus usual care yields significant improvements in pain severity and pain interference (Brief Pain Inventory) as well as in related symptom outcomes from baseline to post-intervention for cancer survivors with persistent pain (as compared to usual care alone). This administrative supplement requests funding to support initially unforeseen administrative and study design modifications that developed during the UG3 phase of the IMPACTS trial and under the advisement of NCI staff, including the following: 1) Provide additional funding to pay site accrual fees resulting from the approved increase in sample size (from 438 to 456; n=18 additional participants) that was implemented to account for changes in standard deviation estimates and effect sizes in power analyses (totaling $54,000); 2) Provide additional funding to pay participant incentives resulting from the approved increase in sample size (from 438 to 456; n=18 additional participants) (totaling $1,800), and 3) Provide additional funding to pay the increase in the standard site accrual fees that has been implemented by NCORP in the time since the IMPACTS study was funded (an increase of $500 per participant) for the originally proposed n = 438 sample of participants (totaling $219,000).