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Peer-to-Peer Support Program in Improving Quality of Life Outcomes in Patients With Gynecologic Cancer and Their Caregivers

2018年5月4日 更新者：City of Hope Medical Center

Quality of Life Outcomes From a Peer-to-Peer Support Program for Women With Gynecologic Cancer

This pilot clinical trial studies a peer-to-peer support program in improving quality of life outcomes in patients with gynecologic cancer and their caregivers. Peer-to-peer support and mentoring may help improve quality of life and reduce symptoms of distress in gynecologic cancer patients and their families.

研究概览

地位

终止

条件

干预/治疗

详细说明

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of a Woman-to-Woman (W2W) program for patients with gynecologic cancer at City of Hope (COH). Address the following descriptive research questions: were patients, mentors, and patients' family caregivers satisfied with the timing, format, and content of the program? Did the program benefit patients, mentors, and patients' family caregivers?

OUTLINE:

Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.

After completion of study, patients are followed up at 6 and 12 months.

研究类型

介入性

注册 (实际的)

3

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Duarte、California、美国、91010
        • City of Hope Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • PATIENT PARTICIPANTS
  • Patients with newly diagnosed or recurrent gynecologic cancer (ovarian, uterine, cervical, vaginal, vulvar) actively undergoing treatment (chemotherapy, surgery, or radiation therapy) at COH (including Duarte and South Pasadena campuses)
  • English-speaking patients
  • PEER MENTORS
  • Peer mentors will be past gynecologic cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
  • Over age 18
  • PEER MENTORS: English-speaking patients
  • This study is open to patients of all races and ethnicities

Exclusion Criteria:

  • PEER MENTORS:
  • Major psychiatric disease
  • Currently undergoing treatment for active gynecologic cancer

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Supportive care (W2W program)
Patients participate in the W2W program for which they are matched with a trained mentor and followed throughout treatment by phone, email, and/or in person.
程序：Supportive Care
Complete W2W mentoring program
其他名称：
  • 支持疗法
  • 症状管理
  • 治疗，支持
其他：Quality-of-Life Assessment
Complete the FACT-G
其他名称：
  • 生活质量评估
其他：Questionnaire Administration
Complete the W2W Patient Survey

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in quality of life benefits for patients, as assessed by the FACT-G
大体时间：Baseline to up to 12 months
Changes from baseline will be tested using paired t-tests. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Baseline to up to 12 months
Satisfaction of patients with the timing, content, and format of the program, as assessed by the W2W Patient Survey
大体时间：Up to 12 months
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools. Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data.
Up to 12 months
Satisfaction of mentors with the timing, content, and format of the program, as assessed by the W2W Volunteer/Mentor Survey
大体时间：Up to 12 months
Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Up to 12 months
Satisfaction of patients' family caregivers with the timing, content, and format of the program
大体时间：Up to 12 months
Changes from baseline will be tested using paired t-tests. Descriptive statistics on participants' satisfaction with the timing, content, and format of the intervention will be presented through summary statistics of data from the satisfaction tools.
Up to 12 months
Benefits for patients' family caregivers after participating in the program, as assessed by the Modified Caregiver Strain Index
大体时间：Up to 12 months
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed. Written comments from all open ended questions analyzed using content analysis methods.
Up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

City of Hope Medical Center

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Thanh Dellinger, MD、City of Hope Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年7月1日

初级完成 (实际的)

2018年4月1日

研究完成 (实际的)

2018年4月1日

研究注册日期

首次提交

2015年4月3日

首先提交符合 QC 标准的

2015年4月7日

首次发布 (估计)

2015年4月8日

研究记录更新

最后更新发布 (实际的)

2018年5月11日

上次提交的符合 QC 标准的更新

2018年5月4日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 14359 (其他标识符：City of Hope Medical Center)
  • NCI-2015-00467 (注册表标识符：CTRP (Clinical Trial Reporting Program))

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Supportive Care的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Switzerland

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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