NCT03413332

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
141

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

5 years

First QC Date

January 5, 2018

Last Update Submit

February 1, 2021

Conditions

Breast Cancer

Keywords

Chinese American WomenProvider-patient CommunicationSurvivorship Care

Outcome Measures

Primary Outcomes (4)

  • Medical Communication Competence Scale

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

    6 months

  • Assessment of Patient Experiences of Cancer Care

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

    6 months

  • Decision-making Participation Self-efficacy Scale

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

    6 months

  • Perceived Personal Control Scale

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

    6 months

Secondary Outcomes (9)

  • PROMIS Fatigue

    6 months

  • PROMIS Sleep Disturbance

    6 months

  • PROMIS Pain Interference

    6 months

  • PROMIS Cognitive Function

    6 months

  • PROMIS Physical Function

    6 months

  • +4 more secondary outcomes

Study Arms (2)

E-Talkcare Group

EXPERIMENTAL

use the web-based patient education tool

Other: E-Talkcare

Usual Care Group

PLACEBO COMPARATOR

receive usual care

Other: Usual Care

Interventions

E-TalkcareOTHER

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.

E-Talkcare Group
Usual CareOTHER

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.

Usual Care Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Judy Wang, Ph.D.

    Georgetown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy Wang, Ph.D.

CONTACT

202-687-6306jw235@georgetown.edu

Jiayan Gu, MSPH

CONTACT

202-687-8007jg1829@georgetown.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 29, 2018

Study Start

April 1, 2017

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations

US(1)