- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846999
Comorbidities and Health Care Services Utilisation Among Long-term Breast Cancer Survivors (SURBCAN)
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of comorbidities
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of visits to primary care attention
Time Frame: 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
Time Frame: 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
Time Frame: 1 year
|
Assessment of the percentage of women who have a mammogram every year.
|
1 year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SURBCAN Project
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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