Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 31, 2022
Date Accepted: Dec 14, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited.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.
Enhancing Self Care Among Oral Cancer Survivors: Protocol for the Empowered Survivor Trial
ABSTRACT
Background:
Oral cavity and oropharyngeal cancer survivors frequently experience difficulties in the ability to swallow, taste, speak, chew, and maintain comfortable movement of the head, neck, and shoulder. Engagement in regular self-care can reduce further loss of function and mitigate late effects. Despite the significant self-care requirements, there are no empirically-based interventions to enhance skills and confidence to manage survivors’ ongoing care.
Objective:
The aim of this study is to describe the rationale and methodology for a randomized controlled trial evaluating Empowered Survivor (ES) versus Springboard Beyond Cancer, a general online program for cancer survivors, on self-efficacy in managing care, preparedness for managing survivorship, and health-related QOL.
Methods:
This study is recruiting 600 individuals diagnosed with oral cavity or oropharyngeal cancer between one and three years ago and are currently cancer-free primarily from state cancer registries who are randomly assigned to either the ES or Springboard Beyond Cancer condition. Participants complete measures of self-efficacy in managing care, preparedness for survivorship, and health-related quality of life, as well as engagement in oral self-exam and head and neck strengthening and flexibility exercises at baseline, 2 months, and 6 months after baseline. The primary aim is to evaluate the impact of ES versus Springboard Beyond Cancer on self-efficacy, preparedness, and quality of life. Secondary aims examine mediators and moderators of ES’s impact on self-efficacy in managing care, preparedness, and health-related quality of life at 6-months. The exploratory aim is a process evaluation of ES to identify potential oncology or community settings for future implementation.
Results:
Multilevel modeling will be used to examine whether there are significant differences between the ES versus Springboard Beyond Cancer intervention over time. Mediational models will evaluate indirect effects of ES on outcomes. Quantitative analyses will evaluate predictors of ES usage and qualitative analyses will evaluate preferred timing and settings for implementation of ES.
Conclusions:
This trial has the potential to improve self-care and health-related quality of life among oral cavity and oropharyngeal cancer survivors. If efficacious, ES could be implemented in oncology care and non-profit organizations focused on oral cancers. The team will create a website that serves as a storing house for all materials where a free information about how to access ES, methods to enhance ES use, information on hard-to-reach survivors, and our publications and presentations.
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