Comorbidities and Health Care Services Utilisation Among Long-term Breast Cancer Survivors (SURBCAN)

February 19, 2019 updated by: Maria Sala, Parc de Salut Mar
The increased likelihood of survival can be explained by numerous factors, such as improvements in breast cancer screening and advances in diagnosis and treatment and aging. This phenomenon is associated with comorbidity due to cancer treatment and external factors like aging or lifestyle. Little is known about how these women follow-up their disease, their pattern of use of health resources and their met and unmet needs. Studying the health needs of these women is a cancer-related priority for Cancer Organizations.The project is aimed at: 1) Describing the comorbidities and patterns of use of primary and specialized care in women who have survived a breast cancer for at least five years; 2) Comparing the comorbidities and patterns of use of long time breast cancer survivors with women without a cancer diagnosis; and 3) Estimating the use of resources in long time survivors of breast cancer adjusted for survival-time and comorbidities.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

21639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a diagnosis of breast cancer (during 2000 until 2006) with a survival period of ≥ 5 years that had a visit with the healthcare services during the period from 2012 to 2016 were identified, as well as those women without a cancer diagnosis and matched by age and area with breast cancer survivors.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SURBCAN Project

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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