Web-Based Communication Education for Breast Cancer Survivorship Care

Breast Cancer Clinical Trial

Official title:

Web-Based Communication Education for Breast Cancer Survivorship Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03413332
• Other study ID #: 2016-1407
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2021
• Source: Georgetown University
• Contact: Judy Wang, Ph.D.
• Phone: 202-687-6306
• Email: jw235[@]georgetown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

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