卵巢癌存活者护理：一项随机对照试验方案

Survivorship Care for Women Living With Ovarian Cancer: Protocol for a Randomized Controlled Trial.

作者信息

Kvale Elizabeth, Phillips Farya, Ghosh Samiran, Lea Jayanthi, Hoppenot Claire, Costales Anthony, Sunde Jan, Badr Hoda, Nwogu-Onyemkpa Eberechi, Saleem Nimrah, Ward Rikki, Balasubramanian Bijal

机构信息

Section of Geriatrics and Palliative Medicine, Department of Medicine, Baylor College of Medicine, Houston, TX, United States.

Steve Hicks School of Social Work, The University of Texas at Austin, Austin, TX, United States.

出版信息

JMIR Res Protoc. 2024 Feb 9;13:e48069. doi: 10.2196/48069.

DOI:10.2196/48069

PMID:38335019

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10891493/

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.

摘要

背景

在美国女性癌症发病率中，卵巢癌排名第12位，在癌症相关死亡原因中排名第5位。卵巢癌的典型治疗主要集中在疾病管理上，很少关注患者的生存需求。定性研究表明生存护理存在差距；然而，缺乏证据支持为卵巢癌患者提供生存护理。我们在卵巢癌幸存者及其护理伙伴的参与下开发了POSTCare生存平台，作为提供以患者为中心的生存护理的一种方式。这一过程以慢性病护理模式和相关行为理论为框架。

目的

本研究的总体目标是测试支持生存质量（QOL）的护理过程。具体目标有三个：第一，测试POSTCare平台在支持生活质量、减轻抑郁症状负担和减轻复发担忧方面的效果。在第二个目标中，我们将研究介导干预效果的因素。我们的最终目标是了解护理平台设计和提供方面可能影响传播潜力的因素。

方法

我们将招募120名卵巢癌幸存者参加一项随机对照试验，并在12周和24周时收集数据。每位参与者将被随机分配到POSTCare平台或生存护理的标准流程中。我们的研究对象将来自德克萨斯州的3家诊所；每位参与者将接受过某种组合的治疗方式；持续维持治疗不排除在外。

结果

我们将以干预后12周时POSTCare - O平台对生活质量的影响作为主要终点进行研究。我们将观察次要结果，包括抑郁症状负担、复发焦虑和身体症状负担。我们将确定对干预效果重要的中介因素，为后续研究的干预修订提供信息。数据收集于2023年11月开始，将持续约2年。我们预计本研究结果将于2026年初发表。