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临床试验/NCT03413332
NCT03413332Unknown不适用

Web-Based Communication Education for Breast Cancer Survivorship Care

Georgetown University2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
141
试验地点
2
主要终点
Perceived Personal Control Scale

研究概览

简要总结

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.

详细描述

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

  • Eligible Chinese women
  • 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.

排除标准

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

结局指标

主要结局

Perceived Personal Control Scale

时间窗: 6 months

4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese

Medical Communication Competence Scale

时间窗: 6 months

16 items to assess information provision, seeking, and verifying; α=.80-.89.

Assessment of Patient Experiences of Cancer Care

时间窗: 6 months

10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese

Decision-making Participation Self-efficacy Scale

时间窗: 6 months

5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese

次要结局

  • PROMIS Fatigue(6 months)
  • PROMIS Pain Interference(6 months)
  • PROMIS Anxiety(6 months)
  • Adherence to Breast Care Guidelines(6 months)
  • PROMIS Sleep Disturbance(6 months)
  • PROMIS Depression(6 months)
  • PROMIS Cognitive Function(6 months)
  • PROMIS Physical Function(6 months)
  • Side/late Effect Assessments(6 months)

研究者

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

Judy Wang

Associate Professor

Georgetown University

研究点 (2)

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