Improving family caregiver and patient outcomes in lung cancer surgery: Study protocol for a randomized trial of the multimedia self-management (MSM) intervention

Abstract

ObjectiveTo describe the study protocol of the Multimedia Self-Management (MSM) intervention to prepare patients and family caregivers (FCGs) for lung cancer surgery. DesignThe study is a five-year, single site, randomized controlled trial of 160 lung cancer surgery FCG and patient dyads (320 total participants), comparing intervention and attention control arms. SettingOne National Cancer-Institute (NCI) designated comprehensive cancer center in Southern California. ParticipantsPatients who are scheduled to undergo lung cancer surgery and their FCGs are enrolled as dyads only. InterventionBased on the Chronic Care Self-Management Model (CCM), the intervention is a nurse-led, caregiver-based, multimedia care program for lung cancer surgery. Its primary focus is to help FCGs develop self-management skills related to their caregiving role through goal setting, proactive planning, building problem-solving skills, and accessing family support services. The intervention also supports dyads to prepare for surgery and post-operative recovery at home. It includes videos, print, web-based, and post-discharge telephone support. Main outcome measuresFCG and patient psychological distress and QOL; FCG burden and preparedness for caregiving; FCG and patient healthcare resource use (in-home nursing care, urgent care/ER visits, readmissions). AnalysisRepeated measures ANCOVA statistical design will be used, removing variances prior to examining mean squares for the group by occasion interactions, and co-varying the baseline scores. In addition, structured equation modeling (SEM) will assess whether mediating and moderating factors are associated with outcomes.ClinicalTrials.gov Identifier: NCT03686007