Web-Based Communication Education for Breast Cancer Survivorship Care

Not Applicable

• Conditions: Breast Cancer

• Registration Number: NCT03413332
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-01-29
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 141

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived Personal Control Scale	6 months	4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese
Medical Communication Competence Scale	6 months	16 items to assess information provision, seeking, and verifying; α=.80-.89.
Assessment of Patient Experiences of Cancer Care	6 months	10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese
Decision-making Participation Self-efficacy Scale	6 months	5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States