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Clinical Trials/NCT03413332
NCT03413332
Unknown
Not Applicable

Web-Based Communication Education for Breast Cancer Survivorship Care

Georgetown University1 site in 1 country141 target enrollmentApril 1, 2017
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Georgetown University
Enrollment
141
Locations
1
Primary Endpoint
Perceived Personal Control Scale
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
March 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Judy Wang

Associate Professor

Georgetown University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Perceived Personal Control Scale

Time Frame: 6 months

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

Medical Communication Competence Scale

Time Frame: 6 months

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

Assessment of Patient Experiences of Cancer Care

Time Frame: 6 months

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

Decision-making Participation Self-efficacy Scale

Time Frame: 6 months

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

Secondary Outcomes

  • 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)

Study Sites (1)

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