Web-Based Communication Education for Breast Cancer Survivorship Care

NCT ID: NCT03413332

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2022-03-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

E-Talkcare Group

use the web-based patient education tool

Group Type: EXPERIMENTAL

E-Talkcare

Intervention Type: OTHER

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 Group

receive usual care

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: OTHER

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.

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Judy Wang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judy Wang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University

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

Site Status: RECRUITING

Countries

United States

Central Contacts

Judy Wang, Ph.D.

Role: CONTACT

jw235@georgetown.edu

202-687-6306

Jiayan Gu, MSPH

Role: CONTACT

jg1829@georgetown.edu

202-687-8007

Facility Contacts

Judy Wang, PhD

Role: primary

jw235@georgetown.edu

202-687-6306

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-1407

Identifier Type: -

Identifier Source: org_study_id