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临床试验/NCT02375776
NCT02375776已完成不适用

Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Multi-modal mHealth Intervention

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Change in Adherence to Oral Anti-Cancer Medications in patients with Renal Cell Cancer or Prostate Cancer on Oral Anti-Cancer Medications.

研究概览

简要总结

This study evaluates a smart phone based mobile application designed for patients with Renal Cell and Prostate Cancer taking oral anti-cancer medications. (OAMs) All participants will be patients at the Dana Farber Cancer Institute in Boston, Massachusetts. Half of the participants will use the mobile application for a 3 month period along with their usual care. Half of the participants will just receive usual care.

The investigators hope to show that cancer patients taking OAMs who use the mobile application will be better connected to their care team and will develop increased competency for self-care which will primarily increase medication adherence.

详细描述

The widespread and increasing use of oral anti-cancer medications (OAMs) has been ushered in by a rapidly increasing understanding of cancer pathophysiology. Furthermore, OAMs' popular ease of administration and potential cost savings has highlighted their central position in the healthcare system as a whole. Importantly, these facts have heightened appreciation of the unique challenges associated with OAMs use, especially in relation to prescribing, dispensing, reimbursement, education, adherence, and comprehensive quality and safety assurance. In this regard, the investigators goal is to improve medication adherence and clinical outcomes for cancer patients using OAMs through a mobile-enabled, multi-modal self-management and educational intervention .

The intervention seeks to enable patients' self-efficacy to adhere to their medications through directed education and coaching, anticipation of symptoms and associated adverse events, and closer monitoring with accurate assessment of self-reported outcomes. This innovative approach necessarily includes personalizing feedback and management based on patients' own treatment regimen, baseline knowledge and elucidated barriers to adherence, and holds great promise in improving overall adherence, safety, and clinical outcomes in these patients.

The investigators hypothesize that cancer patients on OAMs who use a mobile-based, multi-modal health self-management (M health) intervention designed for extensive patient education and symptom management will be better connected to their care team and will develop increased competency for self-care which will primarily increase medication adherence and improve secondary outcomes measured in this study compared to cancer patients on OAMs who do not use the mobile-based intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Adult (≥18 years) patients being treated at the Dana Farber Cancer Institute for Renal Cell Cancer or Prostate Cancer commencing a new course cycle of OAMs. . - -Participants must be ambulatory and able to consent for self.
  • Participants must have an Apple or Android smart phone and be willing to download the mobile application on their smartphones so they can utilize the intervention.
  • Patients must be able to read/speak English.

排除标准

  • Life expectancy less than 3 months as determined by the managing oncologist.
  • Significant psychiatric co-morbidities and memory or cognitive impairments. A significant psychiatric condition includes any condition which creates major distress for a patient or which markedly impairs the patient's daily functioning. It includes, but not limited to, acute psychoses, major depressive disorder, dementia, etc
  • Patients currently on similar interventional studies geared to improve medication adherence or in investigational drug trials in which adverse effects have not been fully elucidated.

结局指标

主要结局

Change in Adherence to Oral Anti-Cancer Medications in patients with Renal Cell Cancer or Prostate Cancer on Oral Anti-Cancer Medications.

时间窗: From randomization to end of study 12 weeks

Medication adherence will be measured throughout the course of the study by the Medication Event Monitoring System. (Continuous data regarding medication adherence will be measured through this device and recorded in real time throughout the study - a period of 3 months.)

次要结局

  • patient engagement with the mobile-based intervention in patients on OAMs.(From randomization to end of study 12 weeks)
  • Severity of symptoms in patients on Oral AntiCancer Medications. (OAMs)(From randomization to end of study 12 weeks)
  • Quality of life metrics in patients on OAMs.(From randomization to end of study 12 weeks)
  • Hospital utilization in patients on OAMs.(From randomization to end of study 12 weeks)
  • Severity of anxiety in patients on OAMS.(From randomization to end of study 12 weeks)
  • Severity of fatigue in patients on OAMs.(From randomization to end of study 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph C. Kvedar

Dermatologist

Massachusetts General Hospital

研究点 (2)

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