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Access My Breast Cancer Care App

8. juli 2026 opdateret af: Kathryn Isaac, University of British Columbia

Access my Breast Cancer Care - Use of an eHealth App in Navigating the Breast Cancer Trajectory: A Randomized Controlled Trial

The Access my Breast Cancer Care application was developed by a multidisciplinary team with the intention of providing breast cancer patients with a centralized area to navigate their journey. Several of the research team members (Dr. Macadam, Dr. Isaac, Selena (CNS) and Pauline (CNS)) provided clinical expertise to ensure accuracy of clinical content. The application houses educational resources, a calendar, symptom tracker, customizable care pathway, community forum and a chat feature. The study will be designed as a randomized controlled trial (RCT) to measure the effect of the application on patient-centered outcomes of 1) satisfaction with care 2) reduction in adverse events, 3) usability. The investigators will conduct focus groups to understand the benefit of the app from the patient perspective.

Studieoversigt

Detaljeret beskrivelse

Background: This App has been developed by stakeholders engaged in breast cancer reconstruction, including patients, physicians, allied health workers, hospital administration, and hospital leadership. Its development and evaluation follow the Cancer Care Research framework to ensure its utility and integration are optimized for impact in cancer care

Purpose: To evaluate whether a centralized breast cancer care app can improve patient navigation, empowerment, and decision-making, while also reducing the number of in person clinic visits, and time from symptom onset to specialist review. The investigators will also evaluate app usability and usage.

Hypothesis: Providing patients with access to the "Access my Breast Cancer Care" app will improve patient care satisfaction and patient outcomes compared to usual standard care, resulting in fewer in person clinic visits, high satisfaction of care, earlier detection of complications, and greater patient confidence in managing their care.

Justification: Breast cancer patients often face fragmented care and difficulty accessing timely resources. A centralized app may provide consistent support, improve communication, and enhance efficiency in care delivery. Evaluating its impact is necessary to determine the benefits to patients and potential cost savings for the healthcare system.

Objectives: 1) To evaluate, from the patient perspective, the impact of a centralized breast cancer app on navigation of the breast cancer journey when undergoing reconstruction; 2) To evaluate the impact of a centralized breast cancer app on the delivery of care, including number of in-person specialist visits and time from symptom onset to specialist review; 3) To evaluate the app usability and usage during the breast cancer journey.

Research design: A mixed methods approach will be utilized. A randomized control trial with both quantitative and qualitative data will be collected and analyzed. Quantitative outcomes include BREAST-Q scores, MARS scores, SUS scores, and delivery of care quality indicators.

Statistical analysis: Qualitative analysis will be completed using constant comparison and retrieval of themes. Primary analysis of patient care satisfaction using the BREAST-Q will be conducted using ANCOVA. For secondary outcomes, the investigators will apply negative binomial regression for number of in person visits, survival analysis using Kaplan-Meier curves, and log-rank test for time to specialist review, gamma regression with log link to assess information seeking time, and wilcoxon sum for app usability using the MARS and/or SUS scale. The investigators will use measures of central tendency to evaluate app usage (# of logins and # of education resources accessed).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

148

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

  • Navn: Selena Banser Clinical Nurse Specialist, RN
  • Telefonnummer: 236-997-9112
  • E-mail: selena.banser@vch.ca

Studiesteder

    • British Columbia
      • Vancouver, British Columbia, Canada
        • Rekruttering
        • Providence Health Care
        • Kontakt:
      • Vancouver, British Columbia, Canada
        • Rekruttering
        • Vancouver Coastal Health
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • You are at least 19 years of age (the team only treats adult patients)
  • You have a diagnosis of breast cancer, or a BRCA mutation, and will be -having breast surgery with reconstruction (the app is tailored the breast cancer journey)
  • You have access to a smartphone or computer (individuals participating in the study will require access to a smart phone or computer to access the application if randomized to the intervention group)
  • Must have basic reading skills in English (the app is only available in English language)

Exclusion Criteria:

  • You do not have access to a smartphone or computer (a computer or smart phone is required to access the application)
  • You are <19 years of age (the team does not treat pediatric patients)
  • You do not have breast cancer or a BRCA mutation (the application is specific to the breast cancer journey)
  • You decline breast reconstruction (the application was designed by the plastics and reconstructive team, and with the app being in an infancy stage, the bulk of the content focuses on breast reconstruction surgery)
  • You are not able to read English (the app is only available in English language)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control
This arm will undergo standard breast cancer care without access to the app
These patients will undergo standard breast cancer care without access to the app
Eksperimentel: App
This arm will undergo standard breast cancer care with access to the app
App designed by our VCH team for patients with breast cancer to navigate their care pathways

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Does access to a centralized breast cancer app improve patient navigation during breast cancer reconstruction journey
Tidsramme: 1 month and 6 months
Assessment will be made using BREAST-Q scores. The BREAST-Q is a patient-reported outcome measure where higher scores (0-100) indicate better quality of life or satisfaction.
1 month and 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Does the app improve reduce the amount of emergency room visits?
Tidsramme: 1 month and 6 months
Compare the number of in emergency department visits between groups.
1 month and 6 months
Does the app reduce wait times to specialist review?
Tidsramme: 1 month and 6 month
Compare time from symptom onset to specialist review between groups
1 month and 6 month

Samarbejdspartnere og efterforskere

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

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)

20. april 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

7. april 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • H25-03017

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

all de-identified IPD will be used in the results publication

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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