Cancer of BreastNCT05729451
Change in Cardiorespiratory Fitness and Breast Cancer Incidence and Mortality
An observational study of Cancer of Breast and Cardiorespiratory Fitness, run by The Swedish School of Sport and Health Sciences.
Trial summary
The aim of this observational study is to investigate the association between mid-life changes in cardiorespiratory fitness and the risk of breast cancer incidence and mortality among Swedish women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer of Breast, Cardiorespiratory Fitness, Occupational Health
- How many people
- 53,644 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1990to 31 Dec 2019
- How long will I take part?
- 10 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study used data from the Health Profile Assessment (HPA) database managed by the HPI Health Profile Institute AB in Stockholm, Sweden. The HPAs, which include a questionnaire on physical activity, lifestyle, and perceived health, as well as body mass and height measurements and a submaximal cardiorespiratory fitness test, have been conducted since the 1970s and stored in a central database since 1990. Participation was optional and offered to employees at no cost through the occupational and health services contracted by HPI and HPI was responsible for the standardization and administration of the database. The HPI-database was coupled to the national death registry to obtain data on cancer incidence and mortality of the involved participants.
Who may be able to join
- Older than 18 years
- Performed at least two health assessment tests
Who cannot join
- Cancer diagnoses prior to the second health assessment test
- Missing data on any exposure or confounder
About this study
Official title: The Association Between Change in Cardiorespiratory Fitness and Breast Cancer Incidence and Mortality
The aim of this observational study is to investigate the association between mid-life changes in cardiorespiratory fitness and the risk of breast cancer incidence and mortality among Swedish women.
The main questions to answer are:
- Are changes in cardiorespiratory fitness associated with the risk of being diagnosed or dying from/with breast cancer later in life?
Participants performed at least two occupational health assessment tests, which consisted of a submaximal ergometer cycle test, measurement of body mass and height to calculate BMI, and a questionnaires on physical and life style habits.
Read the detailed description
PLAN FOR THE STATISTICAL ANALYSES
This plan has been made before any data analysis has been conducted.
The primary statistical analysis aims to determine if there is any association between changes in estimated cardiorespiratory fitness (both absolute L/min and relative ml/min/kg) and breast cancer incidence and mortality.
Cox proportional hazards models will be analysed with inverse probability treatment weights of time-varying confounders such as BMI, physical activity smoking and alcohol. Time stable confounders will be baseline cardiorespiratory fitness, education, co-morbidities. Risk time will be calculated as the time from last cardiorespiratory fitness test to the diagnosis of breast cancer or the end of study. In addition, restricted cubic splines will be performed.
Secondary analysis will be performed to determine if the association remains after dividing into prespecified groups. The first analysis will be conducted by grouping individuals who decrease, stay stable or increase in cardiorespiratory fitness. The second analysis, we will conduct is an analysis to investigate if age (proxy for menopausal status) modifies the relationships between change in cardiorespiratory fitness and breast cancer incidence or mortality. This will be performed in two analyses by splitting on age 50 and 60, respectively. In the third analysis we will investigate if baseline fitness modifies the association. This will be done with fitness both as a continuous and stratified into tertiles.
Proportional hazard assumption was checked using scaled Schönfelts residuals.
Analysis will include four models and include confounders relevant to the outcomes and research questions. These will be as follows:
Model 1: Baseline cardiorespiratory fitness Model 2: Baseline cardiorespiratory fitness, age, education and date of last health assessment test Model 3: Baseline cardiorespiratory fitness, age, education and date of last health assessment test, BMI Model 4: Baseline cardiorespiratory fitness, age, education and date of last health assessment test, BMI, physical activity, smoking and alcohol intake.
Sensitivity analysis: To address potential reverse causality we will exclude individuals who are diagnosed with breast cancer within two years after the last health assessment.
- Keywords
- Cancer, Cardiorespiratory Fitness, Physical activity,
- Medical subject headings
- Breast Neoplasms, Neoplasms, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of breast cancer
ICD 10, C50 Malignant neuroplasm of breast
Measured: From last health assessment test until 31th of December 2019
breast cancer specific mortality
ICD 10, C50 Malignant neuroplasm of breast
Measured: From last health assessment test until 31th of December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jan 1990
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of BreastStudies 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
- Prospective
- Enrolment
- 53,644 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- The Swedish School of Sport and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- HPI Health Profile Institute, Swedish Cancer Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729451
- Sponsor's protocol ID
- Dnr 2015/1864-31/2
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data underlying the findings in this study are currently not publicly available as the original ethical approval application and the informed consent from did not include such direct free access to the data. Data are stored by and can by requested from the HPI Health Profile Institute support@hpi.se.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Change in Cardiorespiratory Fitness and Breast Cancer Incidence and Mortality
- ClinicalTrials.gov ID
- NCT05729451
- Acronym / sponsor ID
- Dnr 2015/1864-31/2
- Keywords
- Cancer, Cardiorespiratory Fitness, Physical activity,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53,644 participants (actual)
- Lead sponsor
- The Swedish School of Sport and Health SciencesUniversity, hospital or other
- Collaborators
- HPI Health Profile Institute, Swedish Cancer Society
- Study start
- 1 Jan 1990 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Feb 2023 (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 aim of this observational study is to investigate the association between mid-life changes in cardiorespiratory fitness and the risk of breast cancer incidence and mortality among Swedish women.
The main questions to answer are:
- Are changes in cardiorespiratory fitness associated with the risk of being diagnosed or dying from/with breast cancer later in life?
Participants performed at least two occupational health assessment tests, which consisted of a submaximal ergometer cycle test, measurement of body mass and height to calculate BMI, and a questionnaires on physical and life style habits.
Detailed description
PLAN FOR THE STATISTICAL ANALYSES
This plan has been made before any data analysis has been conducted.
The primary statistical analysis aims to determine if there is any association between changes in estimated cardiorespiratory fitness (both absolute L/min and relative ml/min/kg) and breast cancer incidence and mortality.
Cox proportional hazards models will be analysed with inverse probability treatment weights of time-varying confounders such as BMI, physical activity smoking and alcohol. Time stable confounders will be baseline cardiorespiratory fitness, education, co-morbidities. Risk time will be calculated as the time from last cardiorespiratory fitness test to the diagnosis of breast cancer or the end of study. In addition, restricted cubic splines will be performed.
Secondary analysis will be performed to determine if the association remains after dividing into prespecified groups. The first analysis will be conducted by grouping individuals who decrease, stay stable or increase in cardiorespiratory fitness. The second analysis, we will conduct is an analysis to investigate if age (proxy for menopausal status) modifies the relationships between change in cardiorespiratory fitness and breast cancer incidence or mortality. This will be performed in two analyses by splitting on age 50 and 60, respectively. In the third analysis we will investigate if baseline fitness modifies the association. This will be done with fitness both as a continuous and stratified into tertiles.
Proportional hazard assumption was checked using scaled Schönfelts residuals.
Analysis will include four models and include confounders relevant to the outcomes and research questions. These will be as follows:
Model 1: Baseline cardiorespiratory fitness Model 2: Baseline cardiorespiratory fitness, age, education and date of last health assessment test Model 3: Baseline cardiorespiratory fitness, age, education and date of last health assessment test, BMI Model 4: Baseline cardiorespiratory fitness, age, education and date of last health assessment test, BMI, physical activity, smoking and alcohol intake.
Sensitivity analysis: To address potential reverse causality we will exclude individuals who are diagnosed with breast cancer within two years after the last health assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study used data from the Health Profile Assessment (HPA) database managed by the HPI Health Profile Institute AB in Stockholm, Sweden. The HPAs, which include a questionnaire on physical activity, lifestyle, and perceived health, as well as body mass and height measurements and a submaximal cardiorespiratory fitness test, have been conducted since the 1970s and stored in a central database since 1990. Participation was optional and offered to employees at no cost through the occupational and health services contracted by HPI and HPI was responsible for the standardization and administration of the database. The HPI-database was coupled to the national death registry to obtain data on cancer incidence and mortality of the involved participants.
Key inclusion criteria (2 listed)
- Older than 18 years
- Performed at least two health assessment tests
Key exclusion criteria (2 listed)
- Cancer diagnoses prior to the second health assessment test
- Missing data on any exposure or confounder
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
Incidence of breast cancer
Time frame: From last health assessment test until 31th of December 2019
ICD 10, C50 Malignant neuroplasm of breast
breast cancer specific mortality
Time frame: From last health assessment test until 31th of December 2019
ICD 10, C50 Malignant neuroplasm of breast
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 15 Feb 2023.
- Individual participant dataSharing planned: No. The data underlying the findings in this study are currently not publicly available as the original ethical approval application and the informed consent from did not include such direct free access to the data. Data are stored by and can by requested from the HPI Health Profile Institute support@hpi.se.
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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 Cancer of Breast and Cardiorespiratory Fitness, run by The Swedish School of Sport and Health Sciences.
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 2 inclusion and 2 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 15 Feb 2023. 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?
Incidence of breast cancer (time frame: From last health assessment test until 31th of December 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.