跳至主要内容
临床试验/NCT03122249
NCT03122249撤回不适用

Use of Telehealth Technologies for Symptom Management Support for People With Advanced Cancer Living in Rural Communities

Stephanie Gilbertson-White2 个研究点 分布在 1 个国家开始时间: 2017年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Measuring change in QOL (FACT-G)

研究概览

简要总结

Nearly 20% of Americans and 41% of Iowans live in rural or non-metropolitan areas.(1) Lack of access to providers, long travel distances, and a disconnected health system contribute to increased distress and lower quality-of-life (QOL) in people with advanced cancer living in rural areas. (2) In the state of Iowa, 94% of rural residents have high-speed internet access. (3) The University of Iowa Health Care (UIHC) eHealth eNovation Center has developed the infrastructure to address the health care access gap in Iowa. The combination of wide availability of high-speed internet and the eHealth network provides an opportunity to develop and test interventions that leverage this infrastructure in order to address this important palliative care gap.

This is a pilot study to evaluate the feasibility of an eHealth self-management intervention for cancer symptom management. The intervention consists of a web-application that provides tailored educational information about cancer symptoms and a monitoring platform to track symptom distress and strategies used to manage them. Participants will also receive e-visits from a research nurse or research assistant via UIHC eHealth and eNovation video platform. The purpose of this study is obtain feasibility data about the intervention for a future RCT and to evaluate the OASIS intervention with patients living in rural Iowa receiving treatment for advanced cancer. The specific aims are:

  1. to evaluate the feasibility of the OASIS intervention to self-manage symptoms of rural patients with advanced cancer, including a) recruitment and retention, b) use patterns, c) usability of each component of the intervention (i.e., the e-visit platform and the web-application), d) acceptability of the intervention and study (i.e., satisfaction, barriers and facilitators to use, burden); and
  2. to determine preliminary effects of the intervention on self-management behaviors and symptom severity, symptom distress, and symptom interference.

详细描述

Overview of study procedures - Participation in the study last for 12 weeks. Phase 1: baseline data collection and orientation to the intervention (week 0); Phase 2: 8 weeks of daily tracking on website and weekly eHealth visits from a nurse and two data collection points (week 4 and week 8); Phase 3: Optional continuation of tracking on website and as needed eHealth visits from a nurse and final data collection (week 12)

Description of the intervention: For a period of eight weeks patients will use the OASIS web-application daily to help them get better control of their cancer symptoms. In addition, to daily symptom and strategy tracking, participants will have eight e-visits with the nurse-coach via the Zoom application through the UIHC eHealth and eNovation Center to evaluate their progress with managing their symptoms, assess for barriers to implementing strategies, and offering coaching on how to improve symptom management. Questionnaires and blood samples will be collected at baseline (week 0) and follow-up (weeks 4, 8, and 12).

Part 1: OASIS web-application. The web-application is a secure web-site developed by The University of Iowa ITS that contains a number of features participants can use to improve their ability to monitor and manage their physical and emotional symptoms. The daily check-in allows participants to keep track of their symptoms and strategies on a day-to-day basis. A data visualization tool provides visual summary of their symptom distress and strategy use over time. A symptom library describes the pathophysiology (in lay language) of 16 common cancer symptoms. A strategy library contains written descriptions and videos of how to implement 47 common symptom management strategies. The contact nurse-coach feature lists the next scheduled coaching visit as well as provides a way to request an extra e-visit sooner if needed. And finally, other resources will provide phone numbers and web links to resources such as the American Cancer Society, the National Cancer Institute, and Patients Like Me. The personal data participants enter into the OASIS web-application is considered level 3 data and will be handled according to The University of Iowa policies and procedure (See X.4 Electronic Records). After baseline data collection, the web-application will guide participants through the web-application to set up their tailored symptom management plan.

Step 1: On the initial login participants will complete an orientation to the intervention that consists of a video and values exercise. The video will briefly describe how physical and emotional symptoms develop during cancer and why symptom management is critically important for patients with advanced cancer. They will then complete a brief values exercise asking them to think about what is important in their lives. The purpose of the values exercise is to help participants make the cognitive connection about how cancer symptoms may be interfering with aspects of their lives they value most.

Step 2: Next the patient will complete a brief profile (first name, age, gender, type of cancer, current cancer treatment) and select an image or avatar for their profile. Going forward computer algorithms that are driven by information provided by the participant will tailor the experience. For example, the cancer ribbon in the OASIS logo will then change to the color associated with their cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18 yrs or older) with a current diagnosis of advanced cancer of solid tumor (stage 3 or 4) origin considered incurable by the treating oncologist,
  • Experiencing with at least one distressing symptoms (rated 3 or greater on 0-10 numeric rating scale for symptom distress),
  • Able to read and write in English
  • Have a laptop, mobile phone and/or tablet with a video camera that can use to access the internet
  • Have high-speed internet connection in his/her home

排除标准

  • Patients who are not able to complete the study surveys (alone or with assistance) due impaired mental, cognitive, or physical status.

结局指标

主要结局

Measuring change in QOL (FACT-G)

时间窗: Week 0,4,8,12

This is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy. This scale is assessing change between four time points.

Measuring change in Health Education Impact Questionnaire (heiQ)

时间窗: Week 0,4, 8, 12

An outcomes and evaluation measure for patient education and self-management interventions for people. This scale is assessing change between four time points

Measuring change in Symptom burden (MDASI - core)

时间窗: Week 0,4, 8, 12

Assess patient-reported symptom severity and interference in patients with cancer. This scale is assessing change between four time points

次要结局

  • Retention rates(Week 12)
  • Recruitment(Week 0)

研究者

发起方
Stephanie Gilbertson-White
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stephanie Gilbertson-White

Assistant Professor

University of Iowa

研究点 (2)

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