ABSTRACT
BACKGROUND: Ovarian cancer ranks 12th in cancer incidence among women in the United States and 5th among causes of cancer-related death. The typical treatment of ovarian cancer focuses on disease management, with little attention given to the survivorship needs of the patient. Qualitative work alludes to a gap in survivorship care; yet, evidence is lacking to support the delivery of survivorship care for individuals living with ovarian cancer. We developed the POSTCare survivorship platform with input from survivors of ovarian cancer and care partners as a means of delivering patient-centered survivorship care. This process is framed by the chronic care model and relevant behavioral theory. OBJECTIVE: The overall goal of this study is to test processes of care that support quality of life (QOL) in survivorship. The specific aims are threefold: first, to test the efficacy of the POSTCare platform in supporting QOL, reducing depressive symptom burden, and reducing recurrence worry. In our second aim, we will examine factors that mediate the effect of the intervention. Our final aim focuses on understanding aspects of care platform design and delivery that may affect the potential for dissemination. METHODS: We will enroll 120 survivors of ovarian cancer in a randomized controlled trial and collect data at 12 and 24 weeks. Each participant will be randomized to either the POSTCare platform or the standard of care process for survivorship. Our population will be derived from 3 clinics in Texas; each participant will have received some combination of treatment modalities; continued maintenance therapy is not exclusionary. RESULTS: We will examine the impact of the POSTCare-O platform on QOL at 12 weeks after intervention as the primary end point. We will look at secondary outcomes, including depressive symptom burden, recurrence anxiety, and physical symptom burden. We will identify mediators important to the impact of the intervention to inform revisions of the intervention for subsequent studies. Data collection was initiated in November 2023 and will continue for approximately 2 years. We expect results from this study to be published in early 2026. CONCLUSIONS: This study will contribute to the body of survivorship science by testing a flexible platform for survivorship care delivery adapted for the specific survivorship needs of patients with ovarian cancer. The completion of this project will contribute to the growing body of science to guide survivorship care for persons living with cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT05752448; https://clinicaltrials.gov/study/NCT05752448. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48069.
ABSTRACT
OBJECTIVE: People with diabetic peripheral neuropathy (DPN) have impaired gait and balance performance. The aim of this study is to investigate therapeutic effectiveness of mechanical stimulation through a wearable foot compression device equipped in a shoe insole on vibration perception, balance control and gait performance in people with DPN. METHODS: Using a single-arm 4-week intervention study design, we examined effectiveness of daily use of shoes equipped with the foot compression device (Footbeat™, AVEX, Grand Junction, CO, USA) on improving vibration perception threshold (VPTmax), skin perfusion pressure (SPP), ankle brachial index (ABI), lower extremities edema (circumferences in the calf and ankle), and motor performance (postural sway with eyes open and closed conditions, and gait performance during normal, dual-task and fast walking). Thirty people with type 2 diabetes and symptoms of PN completed the experimental protocol. RESULTS: Improvements in VPTmax (before = 27.4 V, after = 23.3 V, P = .007, d = 0.33, where d denotes effect size), center-of-mass sway in the mediolateral direction with both eyes open and closed conditions (before = 0.94 cm, after = 0.76 cm, P = .020, d = 0.47; before = 1.10 cm, after = 0.83 cm, P = .033, d = 0.66, respectively), and stride velocity for normal walking, dual-task walking and fast walking tasks (before = 0.87 m/s, after = 0.96 m/s, P = .017, d = 0.41; before = 0.75 m/s, after = 0.91 m/s, P = .001, d = 0.77; before = 1.10 m/s, after = 1.20 m/s, P = .043, d = 0.33, respectively) were found post treatment. There was no significant improvement in SPP, ABI, and circumferences in the calf and ankle. CONCLUSIONS: Our findings suggest the wearable foot compression device may be effective for reducing neuropathic symptoms and enhancing motor performances in people with DPN.