Lifestyle interventions after colorectal cancer surgery using a mobile digital device: a study protocol for a randomized clinical trial (Preprint)

BACKGROUND In treating colorectal cancer, surgical techniques and adjuvant treatments have advanced over the past century, but relatively less attention has been given to improve health-related quality of life (HRQOL). Recent studies report a significant association between cancer recurrence and patient lifestyle after surgery, hence emphasizing the need to assist patients to reduce this risk through appropriate lifestyle choices. OBJECTIVE The proposed study will evaluate the effects of digital interventions on lifestyle after surgery for colorectal cancer using mobile applications. METHODS A randomized controlled trial (RCT) design was proposed. A total of 320 patients diagnosed with colorectal cancer aged between 20 to 70 years were to be enrolled and randomized in equal numbers into four groups (three groups assigned to different mobile applications and a control group). Surveys that evaluate HRQOL, physical measurements, and metabolic parameters (fasting glucose, HbA1c, triglyceride, HDL cholesterol), and fat/muscle mass measurements by abdominal computed tomography (CT), will be conducted prior to surgery and every 6 months post-surgery for 18 months. Statistical analysis will be used to compare the outcomes between groups. RESULTS As of December 2021, enrollment of trial was completed with a total of 313 patients. Baseline clinicopathologic characteristics were comparable between the 4 randomized groups. CONCLUSIONS Results from this study could provide evidence that easily accessible mobile applications can influence patient lifestyles. Results showing minimal effects of such applications could also be constructive for improving healthcare-related applications. CLINICALTRIAL https://cris.nih.go.kr: KCT0005447. Registration date: June 23, 2020. This study protocol has been approved by the Institutional Review Board on July 8, 2021 (2020-1015).