BLOC-II: Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study
Study Details
Study Description
Brief Summary
Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both. However, it is still unclear whether patients with BC are at increased risk of long-term cardiac dysfunction due to the adverse effects of these therapies. In a cross-sectional study in primary care, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, BC survivors were at increased risk of mild systolic cardiac dysfunction (left ventricle ejection fraction (LVEF)< 54%). By contrast, there was no significant difference in an LVEF < 50% or in diastolic dysfunction. To date it remains uncertain whether the mild or subclinical dysfunction we observed predicts further cardiac deterioration. Consequently, the translation of these results into guidelines for the daily practice of the GP is unclear.
Objective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing whether an unselected population of long-term BC survivors is at increased risk of developing cardiac dysfunction, whether in this group at-risk subgroups exists, and what factors are associated with the highest risk.
Study design: A new assessment of cardiac function among women included in the BLOC-I study. This produces a longitudinal matched cohort design consisting of two cohorts in primary care.
Study population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study.
Main study parameters/endpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF <54/50/45%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Breast cancer survivors Survivors of BC, diagnosed ≥11 years ago, who received chemotherapy and/or radiotherapy |
Diagnostic Test: Echocardiography
During echocardiography, the following parameters will be assessed:
Dimensions
Left ventricle function
Right ventricle function
Valves: Aorta valve and pulmonic valve
Other findings such as: frequency, rhythm, quality
|
| Reference population Age and GP matched reference population without a history of cancer |
Diagnostic Test: Echocardiography
During echocardiography, the following parameters will be assessed:
Dimensions
Left ventricle function
Right ventricle function
Valves: Aorta valve and pulmonic valve
Other findings such as: frequency, rhythm, quality
|
Outcome Measures
Primary Outcome Measures
- Left ventricular systolic dysfunction [through study completion (from Ocotober 2022 - December 2024)]
Prevalance of systolic cardiac dysfunction defined as a LVEF <54%
Secondary Outcome Measures
- Clinically used LVEF cut-off points <45% and <50% [through study completion (from Ocotober 2022 - December 2024)]
Prevalance of systolic cardiac dysfunction defined as a LVEF <45% and <50%
- Course of cardiac function [through study completion (from Ocotober 2022 - December 2024)]
Rate of change of systolic and diastolic cardiac function by change in LVEF
- Cardiovascular diseases [through study completion (from Ocotober 2022 - December 2024)]
Prevalence of cardiovascular diseases obtained from electronic patient records
- Symptoms of hearth failure [through study completion (from Ocotober 2022 - December 2024)]
Clinical symptoms of heart failure measured using a self-constructed questionnaire
Other Outcome Measures
- Patient characteristics [through study completion (from Ocotober 2022 - December 2024)]
age, BMI, menopausal state
- Physical activity [through study completion (from Ocotober 2022 - December 2024)]
Changes in Physical Acticity measured with Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)
- Depression [through study completion (from Ocotober 2022 - December 2024)]
Symptoms of depression measured with Hospital Anxiety and Depression Scale - Despression (HADS-D)
- Anxiety [through study completion (from Ocotober 2022 - December 2024)]
Symptoms of anxiety measured with Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
- Fatigue [through study completion (from Ocotober 2022 - December 2024)]
Multidimensional assessment of fatigue mesaured with Multidimensional Fatigue Index - 20 (MFI-20).
- Use of cardiovascular medication [through study completion (from Ocotober 2022 - December 2024)]
Use of cardiovascular medication based on electronic patient records
- Smoking behavior (self-reported pack years) [through study completion (from Ocotober 2022 - December 2024)]
Smoking behavior
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who previously took part in de BLOC-I study will be included. These criteria were:
-
females diagnosed with stage I-III BC at least five years ago or local or locoregional recurrence of BC at least five years ago
-
treatment with chemotherapy and/or radiotherapy.
Exclusion Criteria:
- Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.
Exclusion criteria for the BC survivors in the BLOC-I study were:
-
metastatic disease at the time of BC diagnosis;
-
BC treatment after 80 years of age;
-
history of treatment for other types of cancer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Groningen | Groningen | Netherlands | 9700 AD |
Sponsors and Collaborators
- University Medical Center Groningen
- ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 202100903