Clinical trial NCT03413332: Web-Based Communication Education for Breast Cancer Survivorship Care
Official title: Web-Based Communication Education for Breast Cancer Survivorship Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Chinese American Women
Provider-patient Communication
Survivorship Care
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Medical Communication Competence Scale
timeFrame: 6 months
measure: Assessment of Patient Experiences of Cancer Care
timeFrame: 6 months
measure: Decision-making Participation Self-efficacy Scale
timeFrame: 6 months
measure: Perceived Personal Control Scale
timeFrame: 6 months
Secondary outcomes:
measure: PROMIS Fatigue
timeFrame: 6 months
measure: PROMIS Sleep Disturbance
timeFrame: 6 months
measure: PROMIS Pain Interference
timeFrame: 6 months
measure: PROMIS Cognitive Function
timeFrame: 6 months
measure: PROMIS Physical Function
timeFrame: 6 months
measure: PROMIS Anxiety
timeFrame: 6 months
measure: PROMIS Depression
timeFrame: 6 months
measure: Side/late Effect Assessments
timeFrame: 6 months
measure: Adherence to Breast Care Guidelines
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Judy Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: