Previously submitted to: JMIR mHealth and uHealth (no longer under consideration since May 16, 2022)
Date Submitted: Apr 26, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Lifestyle interventions after colorectal cancer surgery using a mobile digital device: a study protocol for a randomized clinical trial
ABSTRACT
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. Clinical Trial: 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).
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