Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survivor Trial

NIH RePORTER · NIH · R01 · $613,271 · view on reporter.nih.gov ↗

Abstract

Abstract The diagnosis and treatment of oral and oropharyngeal cancers adversely affects the ability to swallow, taste, speak, chew, and maintain movement of the head, neck, and shoulder. To preserve function and reduce late effects, survivors coordinate their long-term medical and psychosocial needs, manage a significant number of daily care routines, and address comorbidities. Despite the significant long-term survivorship care requirements, there are no empirically-based interventions to assist survivors in building skills and confidence to effectively manage their care. We have evaluated the information and support needs of survivors recruited via the New Jersey State Cancer Registry and, using this feedback, designed, and tested the feasibility and preliminary efficacy of Empowered Survivor (ES), an innovative and interactive online intervention. Our results indicated that Empowered Survivor was well-utilized and resulted in significant improvements in self-efficacy in managing care, greater preparedness for managing survivorship, and head and neck specific quality of life (QOL). Engagement in three self-care behaviors (oral self-exam, swallowing and head and neck mobility exercises) increased. The goal of the proposed study is to bolster the ES intervention by enhancing modules and adding two modules based on participant input: Calm and Connect, which focuses on managing psychological concerns, and Maintaining, which focuses on maintaining self-care routines. We will evaluate ES against a free online self-management intervention, Springboard Beyond Cancer (Springboard), which was developed for cancer survivors by the National Cancer Institute and the American Cancer Society. Six hundred patients who have completed treatment between one and three years ago and are currently cancer-free will be recruited via the New Jersey State Cancer Registry or the Cancer Registry of Greater California and randomly assigned to ES or Springboard. Participants will complete measures at baseline, 2, and 6-months post- baseline. Finally, we will engage in a process evaluation of Empowered Survivor to inform future implementation. This single site clinical trial study has four aims. Aim 1 evaluates the impact of ES versus Springboard on the primary outcomes of self-efficacy, preparedness, and head and neck specific QOL. Aim 2 examines mediators (planning, information needs, support needs, activation, fear of recurrence) and moderators (age, race/ethnicity, sex, HPV status, baseline self-efficacy and preparedness) of ES's impact on self-efficacy in managing care, preparedness, and head and neck specific QOL. Aim 3 evaluate the impact of ES versus Springboard Beyond Cancer on the secondary outcomes of engagement in oral self-exams and head and neck mobility exercises. The Exploratory Aim conducts a process evaluation of ES to inform future implementation. Although cancer survivors have many long-term self-care needs, there are few empirically- based self-manageme...

Key facts

NIH application ID
10347328
Project number
5R01CA240344-03
Recipient
RBHS -CANCER INSTITUTE OF NEW JERSEY
Principal Investigator
Sharon L Manne
Activity code
R01
Funding institute
NIH
Fiscal year
2022
Award amount
$613,271
Award type
5
Project period
2020-03-15 → 2023-02-28