An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy
16. februar 2022 oppdatert av: Peking Union Medical College Hospital
An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial
The aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy.
The investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (QoL) scores and reduce adverse events.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
108
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yan Li, Doctor
- Telefonnummer: +86 17600352101
- E-post: liyan0551@163.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- pathological diagnosis of invasive breast cancer
- breast surgery within the past 2-8 weeks
- adult female
- must be able to use mobile phones
- speak and write Chinese fluently to sign the informed consent
Exclusion Criteria:
- severe comorbidity that interferes with outcome evaluation
- insufficient Chinese language skills
- inability to use mobile phones
- cognitive disability to give informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: The intervention group
The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.
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At their enrollment, patients will receive detailed introduction and adequate assistance on the use of the smartphone app.
The smartphone app will offer proper advice for adverse event management based on calculated results by artificial intelligence on the innovative app, which was developed by YL et al.
It was specifically intended for risk prediction, early prevention, as well as management of symptoms and concerns during adjuvant chemotherapy in the treatment of breast cancer.
The app consisted of 4 modules: (1) Module 1: clinical data collection.
(2) Module 2: risk evaluation for 12 common adverse events during breast cancer chemotherapy.
(3) Module 3: personalized prophylaxis based on predicted risks of adverse events.
(4) Module 4: Q&A platform.
Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.
For example, colony-stimulating factors and antibiotics may be used for febrile neutropenia, loperamide (or diphenoxylate plus atropine) as prophylaxis for diarrhea, together with eating low-lactose and low-fat frequent small meals.
5-hydroxytryptamine 3 receptor antagonist, neurokinin 1 receptor antagonist, and/or dexamethasone would be prescribed for patients at high risks of vomiting.
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Aktiv komparator: The control group
The control group will receive conventional adverse event management during chemotherapy.
Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.
|
Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.
For example, colony-stimulating factors and antibiotics may be used for febrile neutropenia, loperamide (or diphenoxylate plus atropine) as prophylaxis for diarrhea, together with eating low-lactose and low-fat frequent small meals.
5-hydroxytryptamine 3 receptor antagonist, neurokinin 1 receptor antagonist, and/or dexamethasone would be prescribed for patients at high risks of vomiting.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline quality of life scores at 4 months
Tidsramme: 1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days)
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Quality of life scores will be assessed using the simplified Chinese version of the Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3).
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1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence and severity of 12 common adverse events
Tidsramme: 4 months after the first cycle (each cycle is 21 days)
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The incidence and severity of 12 common adverse events will be measured with the WHO-toxicity scale.
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4 months after the first cycle (each cycle is 21 days)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Login times
Tidsramme: Documented automatically by the application every two weeks
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Login times to the application during chemotherapy
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Documented automatically by the application every two weeks
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Average time spent on the application
Tidsramme: Documented automatically by the application every two weeks
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Average time spent on the application each time
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Documented automatically by the application every two weeks
|
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Questions addressed on the Q&A platform
Tidsramme: Documented automatically by the application every two weeks
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Questions addressed on the Q&A platform
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Documented automatically by the application every two weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Yan Li, Doctor, Department of Breast Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24.
- Cheng JX, Liu BL, Zhang X, Zhang YQ, Lin W, Wang R, Zhang YQ, Zhang HY, Xie L, Huo JL. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011 Apr 22;11:56. doi: 10.1186/1471-2288-11-56.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
7. mars 2022
Primær fullføring (Forventet)
7. oktober 2022
Studiet fullført (Forventet)
7. desember 2022
Datoer for studieregistrering
Først innsendt
8. februar 2022
Først innsendt som oppfylte QC-kriteriene
16. februar 2022
Først lagt ut (Faktiske)
28. februar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SMART
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
The data will not become available to public.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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