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Web-Based Communication Education for Breast Cancer Survivorship Care

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Georgetown University

Status

Unknown

Conditions

Breast Cancer

Treatments

Other: E-Talkcare
Other: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT03413332
2016-1407

Details and patient eligibility

About

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.

Full 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.

Enrollment

141 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

141 participants in 2 patient groups, including a placebo group

E-Talkcare Group
Experimental group
Description:
use the web-based patient education tool
Treatment:
Other: E-Talkcare
Usual Care Group
Placebo Comparator group
Description:
receive usual care
Treatment:
Other: Usual Care

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Judy Wang, Ph.D.; Jiayan Gu, MSPH

Data sourced from clinicaltrials.gov

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