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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
141
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.
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.
Georgetown University
Washington D.C., District of Columbia, United States
RECRUITINGMedical Communication Competence Scale
16 items to assess information provision, seeking, and verifying; α=.80-.89.
Time frame: 6 months
Assessment of Patient Experiences of Cancer Care
10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese
Time frame: 6 months
Decision-making Participation Self-efficacy Scale
5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese
Time frame: 6 months
Perceived Personal Control Scale
4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese
Time frame: 6 months
PROMIS Fatigue
6 items (e.g., felt tired, exhausted, limited at work); α=.97
Time frame: 6 months
PROMIS Sleep Disturbance
6 items (e.g., sleep not steady, unsatisfied, hard to fall asleep); α=.98
Time frame: 6 months
PROMIS Pain Interference
6 items (e.g., affecting ability to focus, interact with others, run errands); α=.95
Time frame: 6 months
PROMIS Cognitive Function
6 items (e.g., had trouble concentrating, slow thinking, hard to concentrate); α=.95
Time frame: 6 months
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PROMIS Physical Function
8 items (e.g., carry heavy objects, kneeling, doing 2-hour labor work); α=.90
Time frame: 6 months
PROMIS Anxiety
7 items (e.g., felt anxious, nervous, fearful, tense); α=.90
Time frame: 6 months
PROMIS Depression
8 items (e.g., felt helpless, depressed, unhappy, hopeless); α=.90
Time frame: 6 months
Side/late Effect Assessments
31-item measure of patient-reported side/late effects from breast cancer treatment
Time frame: 6 months
Adherence to Breast Care Guidelines
26 yes-no items: receiving breast cancer follow-up care recommendations from doctors
Time frame: 6 months