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Web-Based Communication Education for Breast Cancer Survivorship Care

1. februar 2021 opdateret af: Judy Wang, Georgetown University
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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

141

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Rekruttering
        • Georgetown University
        • Kontakt:
        • Ledende efterforsker:
          • Judy (Huei_Yu) Wang, Ph.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: E-Talkcare Group
use the web-based patient education tool
Andet: 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.
Placebo komparator: Usual Care Group
receive usual care
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Georgetown University

Efterforskere

  • Ledende efterforsker: Judy Wang, Ph.D., Georgetown University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2017

Primær færdiggørelse (Forventet)

31. marts 2022

Studieafslutning (Forventet)

31. marts 2022

Datoer for studieregistrering

Først indsendt

5. januar 2018

Først indsendt, der opfyldte QC-kriterier

26. januar 2018

Først opslået (Faktiske)

29. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2016-1407

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Brystkræft

Kliniske forsøg med E-Talkcare

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