POSTCare-O: A Protocol for a Randomized Controlled Trial of Survivorship Transition Care in Ovarian Cancer (Preprint)

Abstract

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 delivery of survivorship care for individuals living with ovarian cancer. We developed the POSTCare survivorship platform with input from ovarian cancer survivors and care partners as a means of delivering patient-centered survivorship care. This process is framed on the chronic care model and relevant behavioral theory.

The overall goal of this study is to test processes of care that support quality of life in survivorship. The specific aims are three-fold; first to test the efficacy of the POSTCare platform in supporting quality of life, 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 potential for dissemination.

We will enroll 120 ovarian cancer survivors in a randomized controlled trial and collect data at 12 and 24 weeks. Each subject will be randomized to either the POSTCare platform or standard of care process for survivorship. Our subject population will be derived from 3 clinics in Texas; each subject will have received some combination of treatment modalities ; continued maintenance therapy is not exclusionary.

We will examine the impact of the POSTCare-O platform on quality of life at 12 weeks after intervention as the primary endpoint. 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 study.

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 ovarian cancer patients. Accomplishment of this project will help shift the paradigm of survivorship care to include persons living with cancer.

ClincalTrials.gov