NCT05729451

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
53,644

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1990

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, 1990

Completed
30 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

30 years

First QC Date

February 6, 2023

Last Update Submit

February 6, 2023

Conditions

Keywords

Cancer, Cardiorespiratory Fitness, Physical activity,

Outcome Measures

Primary Outcomes (2)

  • Incidence of breast cancer

    ICD 10, C50 Malignant neuroplasm of breast

    From last health assessment test until 31th of December 2019

  • breast cancer specific mortality

    ICD 10, C50 Malignant neuroplasm of breast

    From last health assessment test until 31th of December 2019

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women will be included in the study
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Older than 18 years
  • Performed at least two health assessment tests

You may not qualify if:

  • Cancer diagnoses prior to the second health assessment test
  • Missing data on any exposure or confounder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

January 1, 1990

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

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.