Virginia Sun1, Dan J Raz2, Loretta Erhunmwunsee2, Nora Ruel3, Jacqueline Carranza4, Rosemary Prieto4, Betty Ferrell4, Robert S Krouse5, Ruth McCorkle6, Jae Y Kim2. 1. Division of Nursing Research and Education, Department of Population Sciences, United States of America. Electronic address: vsun@coh.org. 2. Division of Thoracic Surgery, Department of Surgery, United States of America. 3. Biostatistics and Mathematical Modeling Core City of Hope, Duarte, CA, United States of America. 4. Division of Nursing Research and Education, Department of Population Sciences, United States of America. 5. Surgical Services, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, United States of America; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America. 6. School of Nursing, Yale University, New Haven, CT, United States of America.
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.
RCT Entities:
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.
Authors: K M Carroll; C Nich; R L Sifry; K F Nuro; T L Frankforter; S A Ball; L Fenton; B J Rounsaville Journal: Drug Alcohol Depend Date: 2000-01-01 Impact factor: 4.492
Authors: David Cella; David T Eton; Diane L Fairclough; Philip Bonomi; Anne E Heyes; Cheryl Silberman; Michael K Wolf; David H Johnson Journal: J Clin Epidemiol Date: 2002-03 Impact factor: 6.437
Authors: John R Handy; James W Asaph; Laurie Skokan; Carolyn E Reed; Sydney Koh; Gladney Brooks; E Charles Douville; Andrew C Tsen; Gary Y Ott; Gerard A Silvestri Journal: Chest Date: 2002-07 Impact factor: 9.410