Recruiting

Observational Study

Sponsor:

Georgetown University

Code:

NCT03413332

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

E-Talkcare

Usual Care

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT03413332

Start date

Apr 1, 2017

Status verified date

Feb, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: E-Talkcare Group

use the web-based patient education tool

placebo comparator: Usual Care Group

receive usual care

Interventions

E-Talkcare

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.

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.

Primary outcome measure

  • Medical Communication Competence Scale [ Time Frame: 6 months ]
  • Assessment of Patient Experiences of Cancer Care [ Time Frame: 6 months ]
  • Decision-making Participation Self-efficacy Scale [ Time Frame: 6 months ]
  • Perceived Personal Control Scale [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Judy Wang, Ph.D.

202-687-6306jw235@georgetown.edu

Jiayan Gu, MSPH

202-687-8007jg1829@georgetown.edu

Locations

Georgetown University

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Judy Wang, PhD

202-687-6306jw235@georgetown.edu

Principal Investigator:

Judy (Huei_Yu) Wang, Ph.D.

More Information

Sponsor

Georgetown University

Last update posted

Feb 2, 2021

Last verified

Feb, 2021

Keywords

  • Chinese American Women
  • Provider-patient Communication
  • Survivorship Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2021-02-02.