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Web-Based Communication Education for Breast Cancer Survivorship Care

2021年2月1日 更新者:Judy Wang、Georgetown University
This two-phase research plan will develop and test a culturally relevant, web-based patient education program, hereafter known as E-Talkcare. The intervention aims to empower Chinese cancer patients to effectively communicate with different providers in different healthcare settings.

研究概览

地位

未知

条件

详细说明

This two-phase study develops and tests the usability and efficacy of a culturally relevant, web-based patient education program, hereafter known as E-Talkcare, in improving Chinese immigrant breast cancer survivors' competence, perceived control, and self-efficacy in cancer care communication (intermediate outcomes), and patient-reported symptoms, adherence to breast cancer survivorship care guidelines, and quality of life (distal outcomes) versus the usual care control arm. In Phase I, community-based participatory research (CBPR) principles will be used to develop the intervention to educate participants about culture and communication by demonstrating how to ask for and verify information with doctors and use personalized symptom reports, and by providing question prompt lists for doctor visits. In Phase II, the intervention will be tested in a pilot randomized control trial (RCT). Using cases from Los Angeles Cancer Surveillance Program, California Cancer Registry, Maryland Cancer Registry, and clinics from California, 118 Chinese immigrant women (diagnosed with stage 0-III breast cancer and 1-3 years post-diagnosis) will be enrolled and randomized to either the E-Talkcare intervention or a usual care control arm. Participants will be interviewed via telephone at baseline (i.e., pre-randomization), 3-, and 6-months post-randomization.

研究类型

介入性

注册 (预期的)

141

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

    • District of Columbia
      • Washington、District of Columbia、美国、20007
        • 招聘中
        • Georgetown University
        • 接触:
        • 首席研究员:
          • Judy (Huei_Yu) Wang, Ph.D.

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

Eligible Chinese women

  • ≥ age 18
  • foreign-born speaking Mandarin and/or Cantonese,
  • diagnosed with breast cancer at stage 0, I, II or III,
  • 1-3 years post-diagnosis and completed primary treatment (surgery, radiation, and chemotherapy); and
  • no recurrence, and 6) internet access.

Exclusion Criteria:

  • Women with other cancer types are ineligible due to different treatment complications.

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:随机化
  • 介入模型:并行分配
  • 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:E-Talkcare Group
use the web-based patient education tool
Women in the intervention group will receive the E-Talkcare web address, a user name, and a temporary password. The participant will be able to read or listen (through audio narration) to instructions on how to complete the intervention in order, though she can freely navigate between web modules. Each module will have an ever-present indicator (showing users' progress) and a link to for users to continue navigating through modules.We will ask participants to complete the full intervention within 3 months after intervention delivery and then complete a 3-month post-randomization interview (T1). The website will remain open for six months after intervention delivery to allow participants to use QPL if they wish. A 6-month post-randomization interview (T2) will then be administered.
安慰剂比较:Usual Care Group
receive usual care
Survivors randomized to the usual care group will receive care from their doctors as usual, allowing us to compare the intervention against real-world practice to inform next steps. Since we do not know if the intervention will be efficacious, we decided not to provide a delayed intervention to control participants.

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
Medical Communication Competence Scale
大体时间:6 months
16 items to assess information provision, seeking, and verifying; α=.80-.89.
6 months
Assessment of Patient Experiences of Cancer Care
大体时间:6 months
10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese
6 months
Decision-making Participation Self-efficacy Scale
大体时间:6 months
5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese
6 months
Perceived Personal Control Scale
大体时间:6 months
4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese
6 months

次要结果测量

结果测量
措施说明
大体时间
PROMIS Fatigue
大体时间:6 months
6 items (e.g., felt tired, exhausted, limited at work); α=.97
6 months
PROMIS Sleep Disturbance
大体时间:6 months
6 items (e.g., sleep not steady, unsatisfied, hard to fall asleep); α=.98
6 months
PROMIS Pain Interference
大体时间:6 months
6 items (e.g., affecting ability to focus, interact with others, run errands); α=.95
6 months
PROMIS Cognitive Function
大体时间:6 months
6 items (e.g., had trouble concentrating, slow thinking, hard to concentrate); α=.95
6 months
PROMIS Physical Function
大体时间:6 months
8 items (e.g., carry heavy objects, kneeling, doing 2-hour labor work); α=.90
6 months
PROMIS Anxiety
大体时间:6 months
7 items (e.g., felt anxious, nervous, fearful, tense); α=.90
6 months
PROMIS Depression
大体时间:6 months
8 items (e.g., felt helpless, depressed, unhappy, hopeless); α=.90
6 months
Side/late Effect Assessments
大体时间:6 months
31-item measure of patient-reported side/late effects from breast cancer treatment
6 months
Adherence to Breast Care Guidelines
大体时间:6 months
26 yes-no items: receiving breast cancer follow-up care recommendations from doctors
6 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。

调查人员

  • 首席研究员:Judy Wang, Ph.D.、Georgetown University

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 (实际的)

2017年4月1日

初级完成 (预期的)

2022年3月31日

研究完成 (预期的)

2022年3月31日

研究注册日期

首次提交

2018年1月5日

首先提交符合 QC 标准的

2018年1月26日

首次发布 (实际的)

2018年1月29日

研究记录更新

最后更新发布 (实际的)

2021年2月2日

上次提交的符合 QC 标准的更新

2021年2月1日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

E-Talkcare的临床试验

3
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