Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled trial

Background: Women with breast cancer in medically underserved areas are particularly vulnerable to persistent pain and disability. Behavioral pain interventions reduce pain and improve outcomes. Cancer patients in medically underserved areas receive limited adjunctive cancer care, as many lack access to pain therapists trained in behavioral interventions, face travel barriers to regional medical centers, and may have low literacy and limited resources. mHealth technologies have the potential to decrease barriers but must be carefully adapted for, and efficacy-tested with, medically underserved patients. We developed an mHealth behavioral pain coping skills training intervention (mPCST-Community). We now utilize a multisite randomized controlled trial to: 1) test the extent mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress; 2) examine potential mediators of intervention effects; and 3) evaluate the intervention's cost and cost-effectiveness. Methods/design: Breast cancer patients (N = 180) will be randomized to mPCST-Community or an attention control. mPCST-Community's four-session protocol will be delivered via videoconferencing at an underserved community clinic by a remote pain therapist at a major medical center. Videoconference sessions will be supplemented with a mobile application. Participants will complete self-report measures at baseline, post-intervention, and 3- and 6-month follow-ups. Conclusions: mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas. This is one of the first trials to test an mHealth behavioral cancer pain intervention developed specifically for medically underserved communities. If successful, it could lead to widespread implementation and decreased health disparities.