跳至主要内容
临床试验/NCT00900679
NCT00900679已完成不适用

A Standardized Nursing Intervention Protocol for Ovarian Cancer as a Chronic Illness

City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2008年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 3 months

研究概览

简要总结

RATIONALE: A teaching intervention with an advanced practice nurse may help reduce psychosocial and symptom distress and improve the well-being and quality of life of patients with ovarian cancer.

PURPOSE: This clinical trial is studying the effects of a teaching intervention with an advanced practice nurse on quality of life and psychosocial and symptom distress in patients with ovarian cancer.

详细描述

OBJECTIVES:

  • To compare the effects of a standardized nursing intervention protocol (SNIP) model with an advanced practice nurse vs usual care on overall quality of life and psychological distress from initial treatment to 6 months after diagnosis in patients with ovarian cancer.
  • To compare symptom control in these patients.
  • To compare geriatric assessment outcomes in these patients.
  • To compare the effects of the SNIP intervention vs usual care on resource use by these patients.
  • To test the effects of SNIP on patients' and clinicians' satisfaction with care.
  • To describe the effects of SNIP on management of transitions from one phase of chronic illness to another.
  • To identify subgroups of patients with ovarian cancer who benefit most from the SNIP in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors.
  • To obtain feedback from clinicians regarding interpretation of findings and application to the routine care of ovarian cancer patients.

OUTLINE: Patients are stratified according to age (18 to 60 years vs 61 years and over). Patients are sequentially enrolled into 1 of 2 groups. Patients are initially enrolled in group I. Once enrollment in group I is completed, additional patients are enrolled in group II.

  • Group I (usual care): Patients complete questionnaires, including the FACT-Ovarian, Memorial Symptom Assessment Scale, Psychological Distress Thermometer, and Comprehensive Geriatric Assessment, at baseline and at 3 and 6 months. Clinicians also complete questionnaires, including the Clinician Satisfaction with Intervention Questionnaire. Patients' medical charts are reviewed to collect information about treatment, episodes of care, and readmissions.
  • Group II (advanced practice nurse [APN] intervention): Patients undergo face-to-face individualized teaching sessions with an APN twice a month for 2 months. The sessions focus on the patient's physical, psychological, social, and spiritual well-being and the content is tailored to the patient's preferences and needs. Patients are then contacted by the APN via telephone once a month for 4 months to clarify questions and content from the teaching sessions, review any patient concerns, including concerns associated with a transition, and coordinate interdisciplinary resources, including community resources, as needed. Patients and clinicians complete questionnaires as in group I. Patients' medical charts are also reviewed.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • DISEASE CHARACTERISTICS:
  • Diagnosis of ovarian cancer (any stage)
  • PATIENT CHARACTERISTICS:
  • Lives within a 30-mile radius of City of Hope National Medical Center
  • No prior cancer
  • PRIOR CONCURRENT THERAPY:
  • Not specified

排除标准

  • 未提供

结局指标

主要结局

Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 3 months

Quality of life, psychological distress, symptom control, geriatric assessment outcome, and resource use at 6 months

次要结局

未报告次要终点

研究者

发起方
City of Hope Medical Center
申办方类型
Other

研究点 (2)

Loading locations...

相似试验