Breast CancerSURBCANNCT03846999
Comorbidities and Health Care Services Utilisation Among Long-term Breast Cancer Survivors
An observational study of Breast Cancer, run by Parc de Salut Mar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 21,639 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- >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).
Who cannot join
- Unknown diagnostic year
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, comorbidities, healthcare services research, survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Frequency of comorbidities
Number of comorbidities of each woman at five-year survival from breast cancer. Assessed through ICD10.
Measured: 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.
Measured: 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.
Measured: 5 years of survival
Secondary outcomes (3)
Frequency of visits to primary care attention
Number of visits to primary care attention done by each women at five-year survival from breast cancer.
Measured: at 5 years of survival
Frequency of visits to specialized care attention
Number of visits to specialised attention done by each women at five-year survival from breast cancer.
Measured: at 5 years of survival
Annual mammogram frequency
Assessment of the percentage of women who have a mammogram every year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jan 2012
- Primary completion1 Jan 2012
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21,639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, European Regional Development Fund, Red de Investigación en Servicios de Salud en Enfermedades Crónicas
- Responsible party
- Principal investigator, Maria Sala, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846999
- Sponsor's protocol ID
- SURBCAN Project
- Acronym
- SURBCAN
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32912957
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbidities and Health Care Services Utilisation Among Long-term Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03846999
- Acronym / sponsor ID
- SURBCAN / SURBCAN Project
- Conditions
- Breast Cancer
- Keywords
- breast cancer, comorbidities, healthcare services research, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,639 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, European Regional Development Fund, Red de Investigación en Servicios de Salud en Enfermedades Crónicas
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2012 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- >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).
Key exclusion criteria (1 listed)
- Unknown diagnostic year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
3 secondary outcomes
Frequency of visits to primary care attention
Time frame: at 5 years of survival
Frequency of visits to specialized care attention
Time frame: at 5 years of survival
Annual mammogram frequency
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 32912957Jansana 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Parc de Salut Mar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of comorbidities (time frame: 5 years of survival). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03846999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.