Data

Evaluation of clinical pathways and patient outcomes for breast magnetic resonance imaging (MRI) in preoperative assessment and staging of breast cancer: Establishing when MRI improves patient outcomes and when it does not. A multicentre prospective observational trial (BCT 2001 Breast MRI Evaluation)

Breast Cancer Trials (BCT)

Dataset description

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 406 women involved in an observational study to see if a breast Magnetic Resonance Imaging (MRI) of women recently diagnosed with breast cancer impacts on their treatment planning and cancer outcomes. The primary outcome is the clinical utility of MRI in women with newly diagnosed breast cancer on treatment outcomes measured by the proportion of patients whose suggested treatment changes from before they have MRI to after they have MRI as assessed from patient medical records. PROMS explore the participant experience of undergoing MRI, collected at baseline (pre-MRI), post-surgery and at 12 months after registration. Data collected includes preference for surgery type, Ontario Decisional Conflic Scale, EQ-5D-5L, measure of impact of MRI on patient confidence, Decision Regret Scale.
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Subjects

Cancer diagnosis |

Related Study

An observational study to see if a breast Magnetic Resonance Imaging (MRI) of women recently diagnosed with breast cancer impacts on their treatment planning and cancer outcomes (BCT 2001)

Brief Summary

This study aims to find out if having a breast MRI after being diagnosed with breast cancer might change plans for treating the breast cancer and how this might affect patient outcomes. Who is it for? This study may be suitable if you are 18 years or older, have been recently diagnosed with breast cancer and your medical team has suggested that having a breast MRI will help plan your treatment. Trial Details Participants will not need any extra or different procedures or treatments over and above the normal care which has been offered to them by their treatment team. The research team will: * Collect information to be used in the study about participants' cancer, imaging and other tests, and their treatment. * Access clinical information collected during participants' appointments with their doctor about their current cancer care and follow up. * Access participants' clinical data from other health services used or attended as part of their cancer care (e.g. radiology or surgery). This information will be collected for up to 2 years after participant registration to the study. Participants will also be asked to complete some questionnaires to help the researchers understand how the decisions about their treatment based on having an MRI have impacted on them and their lives: * At the start of the study (before MRI): Their preference for surgery/treatment, how much uncertainty they have about making decisions, and their general wellbeing (approximately 10 minutes). * After MRI : Their preference for surgery/treatment, how much uncertainty they have about making decisions, their general well-being, and the impact of the MRI on their confidence in their treatment decision (approximately 5 minutes). * After initial treatment: Their general well-being, impact of MRI on confidence in decision (approximately 5 minutes). * 12 months after registration: Their general well-being, the impact of the MRI on their confidence in their treatment decision and their satisfaction about their decision (approximately 10 minutes). It is hoped that this research will lead to the introduction of MRI as a routine method for diagnosis and informing treatment planning for women diagnosed with breast cancer in the future.

Conditions

Condition Codes

Intervention Code

Inclusion Criteria

  • For inclusion in the study, participants must fulfil all the following criteria: 1) Provide written, informed consent to participate in the study. 2) Female >= 18 years with newly diagnosed early or locally advanced breast cancer for local staging and: a. With ultrasound/mammography, clinical examination results that are discrepant with respect to surgical and other treatment planning; AND/OR b. < 70 years with invasive lobular cancer; AND/OR c. < 50 years; AND/OR d. With reported extreme breast density on mammogram (as defined by the local site); AND/OR e. Breast diagnostic team suggests MRI may contribute to management. 3) Must have had pre-MRI treatment plan determined by diagnostic/treatment team including: a. Type of planned breast and axillary surgery; b. Type of planned radiotherapy to breast/node/chest wall; c. Type of planned systemic therapy (including chemotherapy, HER2 directed therapy, endocrine therapy, neoadjuvant therapy). 4) Be willing and able to comply with requirements of study. 5) Completed baseline PROMs after signing consent and willing to complete specified PROMs in English throughout out the study.

Study Type

  • Observational

Ethics Approval

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Anonymised Individual Patient Data (IPD) collected during the trial.

When will data be available?

Data will be made available for request after publication of the main/final study results; no end date. Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines .

Available to whom?

Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines

Available for what types of analyses?

To achieve the aims in the approved proposal.