- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04834570
Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment
6. april 2021 opdateret af: Thiago Vidal Brito, Instituto Brasileiro de Controle do Cancer
Breast cancer directly affects women physically, psychologically and socially in the process of diagnosis, treatment and post-treatment.
Despite the improvement in conventional breast cancer treatments that led to longer disease-free survival, many patients still suffer from physical, psychological, social and spiritual problems after treatment.
The neglect of physical and psychosocial problems faced by patients who are between 1 and 2 years after the end of treatment negatively impacts the quality of life of this population.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of the study is to assess the overall quality of life and measure the impact on women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment and to identify possible repercussions of breast cancer and its treatments associated with Quality of Life.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
105
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Alayne Domingues Yamada, PhD
- Telefonnummer: +55 11 98141-7613
- E-mail: alayne.pesquisa@ibcc-mooca.org.br
Undersøgelse Kontakt Backup
- Navn: Thiago Brito, MD
- Telefonnummer: +55 21 97154-0865
- E-mail: tcgvidal@hotmail.com
Studiesteder
-
-
-
São Paulo, Brasilien, 03102002
- Rekruttering
- IBCC Oncologia
-
Kontakt:
- Thiago Vidal Brito, MD
- Telefonnummer: +55 21 97154-0865
- E-mail: tcgvidal@hotmail.com
-
Kontakt:
- Felipe José Silva Melo Cruz, PhD
- Telefonnummer: +5511994466537
- E-mail: felipemcruz@yahoo.com.br
-
Ledende efterforsker:
- Thiago Vidal Brito, MD
-
-
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
20 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Recruitment of 100 breast cancer patients who have completed treatment within a minimum of 1 year and are currently undergoing outpatient follow-up
Beskrivelse
Inclusion Criteria:
- Breast cancer
- Adult women (age ≥ 20 years old and less than 60 years old)
- Patient who has been treated by surgery, with or without adjuvant chemotherapy
- Clinical Stages I, II and III
- Patients considered cured, without history of recurrences
- Patients who completed treatment within a minimum of 1 year and are currently being undergoing outpatient follow-up
Exclusion Criteria:
- Initial diagnosis of another type of cancer, other than breast cancer
- Bilateral breast cancer
- Patient unable to fill out the QoL questionnaire
- Patient with disease recurrence
- Patient with metastatic breast cancer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Breast Cancer Survivors
Women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment
|
The patient will receive the following questionnaires to be completed :
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Global Health Status by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire)
Tidsramme: 1 year after treatment ends; 2 years after treatment ends;
|
This questionnaire was designed to be cancer specific, and includes all emotional, social and physical aspects of the individual's life.
The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.
|
1 year after treatment ends; 2 years after treatment ends;
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of life specific for breast cancer by EORTC QLQ-BR23 (European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire)
Tidsramme: 1 year after treatment ends; 2 years after treatment ends;
|
The questionnaire contains 23-item, two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms.
The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
|
1 year after treatment ends; 2 years after treatment ends;
|
Quality of life by FACT-B+4 (Functional Assessment of Cancer Therapy-Breast)
Tidsramme: 1 year after treatment ends; 2 years after treatment ends;
|
The FACT-B+4 questionnaire (Functional Assessment of Cancer Therapy-Breast) consists of 40 questions: 27 about general quality of Life and 13 about breast cancer.
It is fur-ther structured into five subscales: physical, family-social, emotional, functional well-being and a last part specific for breast cancer.
The result given by the sum of the scores goes from zero to 164: a higher score corresponds to major well-being of the patient.
|
1 year after treatment ends; 2 years after treatment ends;
|
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)
5. oktober 2020
Primær færdiggørelse (Forventet)
1. november 2021
Studieafslutning (Forventet)
1. november 2022
Datoer for studieregistrering
Først indsendt
1. april 2021
Først indsendt, der opfyldte QC-kriterier
6. april 2021
Først opslået (Faktiske)
8. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 32155120.7.0000.0072
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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