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Web-Based Communication Education for Breast Cancer Survivorship Care

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ClinicalTrials.gov Identifier: NCT03413332
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Judy Wang, Georgetown University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: E-Talkcare Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Web-Based Communication Education for Breast Cancer Survivorship Care
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: E-Talkcare Group
use the web-based patient education tool
Other: 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.

Placebo Comparator: Usual Care Group
receive usual care
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.




Primary Outcome Measures :
  1. Medical Communication Competence Scale [ Time Frame: 6 months ]
    16 items to assess information provision, seeking, and verifying; α=.80-.89.

  2. 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

  3. 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

  4. Perceived Personal Control Scale [ Time Frame: 6 months ]
    4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese


Secondary Outcome Measures :
  1. PROMIS Fatigue [ Time Frame: 6 months ]
    6 items (e.g., felt tired, exhausted, limited at work); α=.97

  2. PROMIS Sleep Disturbance [ Time Frame: 6 months ]
    6 items (e.g., sleep not steady, unsatisfied, hard to fall asleep); α=.98

  3. PROMIS Pain Interference [ Time Frame: 6 months ]
    6 items (e.g., affecting ability to focus, interact with others, run errands); α=.95

  4. PROMIS Cognitive Function [ Time Frame: 6 months ]
    6 items (e.g., had trouble concentrating, slow thinking, hard to concentrate); α=.95

  5. PROMIS Physical Function [ Time Frame: 6 months ]
    8 items (e.g., carry heavy objects, kneeling, doing 2-hour labor work); α=.90

  6. PROMIS Anxiety [ Time Frame: 6 months ]
    7 items (e.g., felt anxious, nervous, fearful, tense); α=.90

  7. PROMIS Depression [ Time Frame: 6 months ]
    8 items (e.g., felt helpless, depressed, unhappy, hopeless); α=.90

  8. Side/late Effect Assessments [ Time Frame: 6 months ]
    31-item measure of patient-reported side/late effects from breast cancer treatment

  9. Adherence to Breast Care Guidelines [ Time Frame: 6 months ]
    26 yes-no items: receiving breast cancer follow-up care recommendations from doctors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413332


Contacts
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Contact: Judy Wang, Ph.D. 202-687-6306 jw235@georgetown.edu
Contact: Jiayan Gu, MSPH 202-687-8007 jg1829@georgetown.edu

Locations
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United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Judy Wang, PhD    202-687-6306    jw235@georgetown.edu   
Principal Investigator: Judy (Huei_Yu) Wang, Ph.D.         
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Judy Wang, Ph.D. Georgetown University
  Study Documents (Full-Text)

Documents provided by Judy Wang, Georgetown University:
Study Protocol  [PDF] January 30, 2017
Statistical Analysis Plan  [PDF] January 30, 2017


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Responsible Party: Judy Wang, Associate Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT03413332     History of Changes
Other Study ID Numbers: 2016-1407
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Judy Wang, Georgetown University:
Chinese American Women
Provider-patient Communication
Survivorship Care

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases