- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03846999
Comorbidities and Health Care Services Utilisation Among Long-term Breast Cancer Survivors (SURBCAN)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
The general objective of this study is to analyze the pattern of comorbidities and utilization of primary care officers and specialized attention of long-term breast cancer survivors and to compare it with women without history of cancer. Long-term breast cancer survivors are those women who survived for at least five years since de primary breast cancer diagnosis.The use of health care services for long-term breast cancer survivors presents new challenges for health systems in terms of defining the role of each health professional and each level of care in contact with these women during their follow-up.
The SURBCAN Project is an observational study that includes a retrospective cohort of women from five Spanish areas. The study is based on Real World Data from clinical history and tumor registration. Women with a diagnosis of breast cancer and a survival period of ≥ 5 years were identified, as well as those women without a cancer diagnosis and matched by age and area with breast cancer survivors (1:2). N= 21639 women (7241 cases /13,398 controls). Sociodemographic and clinical variables were included. The use of primary care and hospital attention and the presence of comorbidities were assessed during the follow-up period (2012-2016). The basal cohort, the comorbidities and the use of health services were described. Factors associated with use were analyzed through multi-level logistic regression models.
Expected results: Nowadays there are no results of cohort analysis that focus specifically in long-term breast cancer survivors. The SURBCAN study will provide evidence regarding comorbidity patterns and follow-up characteristics. The results will guide the elaboration of new recommendations and the decision making by stakeholders concerned to breast cancer survivor's follow-up.
This project combines the experience from experts groups in health services assessment, and analysis of comorbidities and chronic diseases, belonging to the REDISSEC network.
Studientyp
Einschreibung (Tatsächlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- >18 years old
- Women diagnosed with an incident breast cancer during the period from 01/01/2000 until 31/12/2006 who survived for at least 5 years.
- Women who visited at least once the primary health services during follow-up period (01/01/2012 to 31/12/2016).
Exclusion Criteria:
- Unknown diagnostic year
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
---|
Long-term breast cancer survivors
Analyze comorbidities and patterns of use of health services. Describe the specific use of health services in primary care vs. specialized care. Analyze comorbidities and patterns of use of health services by tumor characteristics. |
Women without history of cancer
Analyze comorbidities and patterns of use of health services.
Describe the specific use of health services in primary care vs. specialized care.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Frequency of comorbidities
Zeitfenster: 5 years of survival
|
Number of comorbidities of each woman at five-year survival from breast cancer.
Assessed through ICD10.
|
5 years of survival
|
Frequency of visits to healthcare services
Zeitfenster: 5 years of survival
|
Number of visits to primary care attention or specialised attention done by each women at five-year survival from breast cancer.
|
5 years of survival
|
Main health provider visited
Zeitfenster: 5 years of survival
|
Leading provider of health services (GP, oncologist, community nurse, oncology nurse, physiotherapist...) of each women at five-year survival from breast cancer.
|
5 years of survival
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Frequency of visits to primary care attention
Zeitfenster: at 5 years of survival
|
Number of visits to primary care attention done by each women at five-year survival from breast cancer.
|
at 5 years of survival
|
Frequency of visits to specialized care attention
Zeitfenster: at 5 years of survival
|
Number of visits to specialised attention done by each women at five-year survival from breast cancer.
|
at 5 years of survival
|
Annual mammogram frequency
Zeitfenster: 1 year
|
Assessment of the percentage of women who have a mammogram every year.
|
1 year
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SURBCAN Project
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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