My Surgical Success: A Randomized Controlled Pilot Study of a Pre-surgical Psychological Intervention

Pre-surgical patients are identified by their breast surgeon. The entire study is conducted remotely with no in-person contact with study staff. Study staff call patients and invite them to enroll in the study; informed consent is obtained online. All participants are asked to provide baseline demographic information, as well as self-reported measures assessing mood, pain, cognitive and emotional responses to pain, catastrophizing, self-efficacy, and medications. All measures are administered via a secure, HIPAA compliant, online system (REDCap). Participants are then randomized to either the Internet-based pain psychology intervention (My Surgical Success) or to brief online health education (HE Control). Prior to surgery, participants who have been randomized to the HE control group will receive patient handouts online about health and nutrition and are oriented that the information is relevant for improving recovery from surgery. The Internet-based pain psychology intervention emphasizes treatment content that targets pain catastrophizing. My Surgical Success includes a psychoeducational video, a downloadable audio file, and a downloadable PDF Personalized Plan for Success. After viewing the online treatment video, participants randomized to My Surgical Success complete questions regarding participant satisfaction with the video, perceived usefulness of information, and likelihood to use the skills learned. Pain catastrophizing scores are collected from all study participants prior to surgery. All participants are tracked daily post-surgically to assess pain, opioid use, distress, and use of skills learned from treatment; data are captured daily for 30 days, then weekly for 2 weeks, then every 2 weeks for 4 weeks to pain and opioid cessation (or the end of 12 weeks). Psychosocial data are collected post-surgically at weeks 2, 4, 8, and 12. Post-treatment questions: Participants in the My Surgical Success group complete the following questions at the end of the video: how understandable the video was, its relevance, usefulness, their satisfaction, how likely they are to use the information, and what they learned from the video. Participants in HE Control are asked how understandable the health information packet was, its relevance, usefulness, their satisfaction, how likely they are to use the information, and what they learned from the packet. The pain catastrophizing scale (PCS) is administered following treatment and before surgery to all participants. Following surgery, all participants fill out online daily measures to assess pain and medication use. Daily measures continue until the participant reports 3 consecutive reports of zero average pain and zero opiate use and has indicated they have recovered from surgery. Until reaching this endpoint, daily measures are collected for 30 days, then bi-weekly for an additional 2 weeks, and then weekly for a period of between 2-6 additional weeks.