ABSTRACT
OBJECTIVE: To describe the study protocol of the Multimedia Self-Management (MSM) intervention to prepare patients and family caregivers (FCGs) for lung cancer surgery. DESIGN: The 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. SETTING: One National Cancer-Institute (NCI) designated comprehensive cancer center in Southern California. PARTICIPANTS: Patients who are scheduled to undergo lung cancer surgery and their FCGs are enrolled as dyads only. INTERVENTION: Based 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 MEASURES: FCG 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). ANALYSIS: Repeated 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.
