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临床试验/NCT01833637
NCT01833637已完成不适用

Electronic Patient Reported Symptom Assessment: A Pilot Study Introducing Advanced Care Planning and Palliative Care to Hospitalized Women With Advanced Gynecologic, Breast, Thoracic, or Gastrointestinal Malignancies.

Northwestern University2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Trend perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.

研究概览

简要总结

The purpose of this study is to assess whether using computerized screening questions can improve how well we manage symptoms related to cancer and cancer treatments. Advance care planning is a process in which teams of experts assist in with treatment plans, managing pain and other symptoms, emotional issues, and end of life issues. With advances in technology, it is now possible to get the patient's feedback directly and more often. It is thought that repeated questionnaires completed by the patient will provide a better and more accurate measure of the patient's needs and experiences but this has not been tested. This study is designed to learn if using a computerized assessment repeatedly is better than standard planning techniques.

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
Female
接受健康志愿者

入选标准

  • Women who have a diagnosis of metastatic breast, gynecologic, thoracic, or gastrointestinal malignancy. Women diagnosed with non-solid organ tumors (i.e., lymphoma, leukemia) will be excluded as their symptom profile in advanced/metastatic disease is dissimilar.
  • Reason for admission must be for symptom management from cancer or cancer therapy.
  • Patients must be age 18 or older.
  • Only patients cared for at the Robert H. Lurie Comprehensive Cancer Center (RHLCCC) will be eligible for this small pilot study.
  • Patients must not be enrolled in hospice care.
  • Patients must have a performance status 0-3 (ECOG scale).
  • Patients must be alert and oriented to time, place, and person. Must be able to answer questions.
  • Patients must be able to speak, read, and communicate in English.
  • Patients must have a signed consent and authorization for research and be amenable to be followed for outcomes/response throughout and after hospitalization.

排除标准

  • 未提供

研究组 & 干预措施

Arm A: Control Group

No Intervention

Patients randomized to the control group will be asked to fill out a patient symptom questionnaire using an iPad at the time of registration and then every 24 hours until released from the hospital. It should take about 10 minutes to complete the questions each time. The survey will not interfere with the care the healthcare team will be providing. Patients will be asked to fill our a Patient Satisfaction Questionnaire at the time of discharge.

Arm B: APN Intervention Group

Active Comparator

Patients randomized to this group will be asked to fill out a patient symptom assessment using an iPad at the time of registration and then every day until released from the hospital. It should take about 10 minutes to complete this questionnaire each time. Based on the patients' answers and in cooperation with their health care provider, an Advanced Practice Nurse (APN) will provide information about symptom management and options for services that are available after the patient leaves the hospital. The survey responses will be shared with the patients' healthcare team so that they better understand how they are feeling. The APN will work closely with the healthcare team. Patients will be asked to fill out a Patient Satisfaction Questionnaire at the time of discharge.

干预措施: APN Intervention (Other)

结局指标

主要结局

Trend perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.

时间窗: 3 years

We will compare the symptom scores of the control and the intervention groups to determine if the overall symptom burden scores are lower and patient satisfaction scores are higher in the group who receive targeted intervention combined with education.

Identify perceived symptom burden and quality of life in our female patients with advanced gynecologic, breast, thoracic, or gastrointestinal malignancies.

时间窗: 3 years

We will compare the symptom scores of the control and the intervention groups to determine if the overall symptom burden scores are lower and patient satisfaction scores are higher in the group who receive targeted intervention combined with education.

次要结局

  • Assess level of understanding about advance care planning in both the control and intervention group.(3 years)
  • Examine scores of electronic reported symptom assessment combined with targeted intervention to see it it improves symptoms scores over the course of hospitalization.(3 years)
  • Use electronic symptom scoring, targeted intervention, and sequential assessments every 24 hours to assess the impact on length of hospitalization and readmissions.(3 years)

研究者

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

Emily Berry

Physician

Northwestern University

研究点 (2)

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