NCT03846999

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21,639

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

Same day

First QC Date

February 13, 2019

Last Update Submit

February 19, 2019

Conditions

Keywords

breast cancercomorbiditieshealthcare services researchsurvival

Outcome Measures

Primary Outcomes (3)

  • Frequency of comorbidities

    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

    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

    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 Outcomes (3)

  • Frequency of visits to primary care attention

    at 5 years of survival

  • Frequency of visits to specialized care attention

    at 5 years of survival

  • Annual mammogram frequency

    1 year

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsLong-term breast cancer survivors (women who survived at least 5 years from the diagnosis)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \>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).

You may not qualify if:

  • \- Unknown diagnostic year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jansana A, Del Cura I, Prados-Torres A, Sanz Cuesta T, Poblador-Plou B, Gimeno Miguel A, Lanzuela M, Ibanez B, Tamayo I, Moreno-Iribas C, Padilla-Ruiz M, Redondo M, Comas M, Domingo L, Diaz-Holgado A, Salamanca FJ, Castells X, Sala M; SURBCAN group. Use of real-world data to study health services utilisation and comorbidities in long-term breast cancer survivors (the SURBCAN study): study protocol for a longitudinal population-based cohort study. BMJ Open. 2020 Sep 9;10(9):e040253. doi: 10.1136/bmjopen-2020-040253.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Evaluation and Quality, MD, PhD

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 20, 2019

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

December 31, 2016

Last Updated

February 20, 2019

Record last verified: 2019-02