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临床试验/NCT02816866
NCT02816866已完成不适用

Comparing Two Modes of Survivorship Care: A Randomized Trial

Yale University0 个研究点目标入组 106 人开始时间: 2010年7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
106
主要终点
adherence to guideline-recommended surveillance (medical record abstraction)

研究概览

简要总结

The main purpose of this study is to research the comparative effectiveness of two potential models of health care to deliver preventive services and chronic care management to the growing population of adult and pediatric survivors of childhood cancer. The central hypothesis is that survivorship care delivered by a subject's primary care doctor after the subject is empowered with individualized follow-up recommendations prepared by a cancer survivor specialist is similar to care provided in a specialty survival clinic.

详细描述

Although 80% of children with cancer will be cured of their primary disease, at least 70% of survivors will develop chronic medical, neurocognitive, and/or emotional conditions as a complication of their therapy. Most of these conditions are amenable to prevention and early intervention. In response, the Institute of Medicine strongly advised that all cancer patients should receive survivorship care with the following key elements: 1) a summary of previous cancer therapy, 2) individualized life-long screening for potential adverse therapy-related effects, and 3) education regarding desirable health behaviors. However, less than 30% of survivors receive recommended care. There is a tremendous need for research that addresses how to best implement evidence-based recommendations for this population.

Two main health care delivery models have been advocated for survivorship care, but no comparison studies exist. The first model is a specialty survivor clinic, usually at a cancer treatment center. The second model, termed the empowered primary care model, involves patients receiving an individualized "prescription" for follow-up care prepared by a cancer survivor specialist to be implemented by the primary care doctor. Each model poses unique strengths and weaknesses. Specialty survivor clinics can be expensive and geographically inaccessible, can cause anxiety and stress to patients, and can accommodate limited numbers of patients. Primary care doctors may lack adequate expertise and time for these complex patients. Unless we know how these approaches compare with regard to quality of care and risks, advocates and policy makers will be stymied in their efforts to support the health needs of cancer survivors. This study seeks to compare subjects randomized to the empowered primary care model vs. a specialty survivor clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of any malignancy at age <18 years and reported to Yale-New Haven Hospital or Connecticut Children's Medical Center (CCMC) tumor registry
  • Currently alive and cancer-free
  • Primary residence within approximately 100 miles of Yale-New Haven Hospital or CCMC
  • ≥ 1 year status post completion of all cancer-related therapy
  • Elapsed time of less than 12.0 years since diagnosis of malignancy
  • Speaking and writing knowledge of English. For subjects <18 years, at least one parent must satisfy this requirement.
  • No previous attendance at the Yale HEROS or CCMC Reach for the STARS survivorship clinics, or other specialty survivorship clinic

排除标准

  • 未提供

结局指标

主要结局

adherence to guideline-recommended surveillance (medical record abstraction)

时间窗: 12 months post-intervention

quality of survivorship care

number of newly-identified late effects of therapy (medical record abstraction)

时间窗: 12 months post-intervention

quality of survivorship care

次要结局

  • depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))(12 months post-intervention)
  • level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))(12 months post-intervention)
  • intake of at least five servings per day of fruits and vegetables (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))(12 months post-intervention)
  • anxiety (Brief Symptom Inventory (BSI))(12 months post-intervention)
  • post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))(12 months post-intervention)
  • avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))(12 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

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