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Web-Based Communication Education for Breast Cancer Survivorship Care

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-Talkcare
Usual Care
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Chinese American Women, Provider-patient Communication, Survivorship Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Georgetown UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

E-Talkcare Group

Usual Care Group

Arm Description

use the web-based patient education tool

receive usual care

Outcomes

Primary Outcome Measures

Medical Communication Competence Scale
16 items to assess information provision, seeking, and verifying; α=.80-.89.
Assessment of Patient Experiences of Cancer Care
10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese
Decision-making Participation Self-efficacy Scale
5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese
Perceived Personal Control Scale
4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese

Secondary Outcome Measures

PROMIS Fatigue
6 items (e.g., felt tired, exhausted, limited at work); α=.97
PROMIS Sleep Disturbance
6 items (e.g., sleep not steady, unsatisfied, hard to fall asleep); α=.98
PROMIS Pain Interference
6 items (e.g., affecting ability to focus, interact with others, run errands); α=.95
PROMIS Cognitive Function
6 items (e.g., had trouble concentrating, slow thinking, hard to concentrate); α=.95
PROMIS Physical Function
8 items (e.g., carry heavy objects, kneeling, doing 2-hour labor work); α=.90
PROMIS Anxiety
7 items (e.g., felt anxious, nervous, fearful, tense); α=.90
PROMIS Depression
8 items (e.g., felt helpless, depressed, unhappy, hopeless); α=.90
Side/late Effect Assessments
31-item measure of patient-reported side/late effects from breast cancer treatment
Adherence to Breast Care Guidelines
26 yes-no items: receiving breast cancer follow-up care recommendations from doctors

Full Information

First Posted
January 5, 2018
Last Updated
February 1, 2021
Sponsor
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT03413332
Brief Title
Web-Based Communication Education for Breast Cancer Survivorship Care
Official Title
Web-Based Communication Education for Breast Cancer Survivorship Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Chinese American Women, Provider-patient Communication, Survivorship Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-Talkcare Group
Arm Type
Experimental
Arm Description
use the web-based patient education tool
Arm Title
Usual Care Group
Arm Type
Placebo Comparator
Arm Description
receive usual care
Intervention Type
Other
Intervention Name(s)
E-Talkcare
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
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 Information:
Title
Medical Communication Competence Scale
Description
16 items to assess information provision, seeking, and verifying; α=.80-.89.
Time Frame
6 months
Title
Assessment of Patient Experiences of Cancer Care
Description
10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese
Time Frame
6 months
Title
Decision-making Participation Self-efficacy Scale
Description
5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese
Time Frame
6 months
Title
Perceived Personal Control Scale
Description
4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PROMIS Fatigue
Description
6 items (e.g., felt tired, exhausted, limited at work); α=.97
Time Frame
6 months
Title
PROMIS Sleep Disturbance
Description
6 items (e.g., sleep not steady, unsatisfied, hard to fall asleep); α=.98
Time Frame
6 months
Title
PROMIS Pain Interference
Description
6 items (e.g., affecting ability to focus, interact with others, run errands); α=.95
Time Frame
6 months
Title
PROMIS Cognitive Function
Description
6 items (e.g., had trouble concentrating, slow thinking, hard to concentrate); α=.95
Time Frame
6 months
Title
PROMIS Physical Function
Description
8 items (e.g., carry heavy objects, kneeling, doing 2-hour labor work); α=.90
Time Frame
6 months
Title
PROMIS Anxiety
Description
7 items (e.g., felt anxious, nervous, fearful, tense); α=.90
Time Frame
6 months
Title
PROMIS Depression
Description
8 items (e.g., felt helpless, depressed, unhappy, hopeless); α=.90
Time Frame
6 months
Title
Side/late Effect Assessments
Description
31-item measure of patient-reported side/late effects from breast cancer treatment
Time Frame
6 months
Title
Adherence to Breast Care Guidelines
Description
26 yes-no items: receiving breast cancer follow-up care recommendations from doctors
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy Wang, Ph.D.
Phone
202-687-6306
Email
jw235@georgetown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayan Gu, MSPH
Phone
202-687-8007
Email
jg1829@georgetown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Wang, Ph.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Wang, PhD
Phone
202-687-6306
Email
jw235@georgetown.edu
First Name & Middle Initial & Last Name & Degree
Judy (Huei_Yu) Wang, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Web-Based Communication Education for Breast Cancer Survivorship Care

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