Breast Cancer – Our Trials

Our Trials

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For those patients aged 50 or older at diagnosis, there is no clear evidence or consensus amongst specialists on risk-factors to advise the optimum frequency or duration of follow-up mammograms. In order to provide sound evidence for future management, this clinical trial aims to establish if patients aged 50 years or over can be identified, who require less frequent mammographic surveillance whilst investigating alternative methods of follow-up.
Breast cancer is the most frequent cancer among women and is a major cause of cancer-related deaths worldwide.

The most prevalent sub-type of breast cancer is hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and accounts for 70% of all breast cancers.

Approximately 90% of breast cancer patients are diagnosed at an early stage of their disease. With current standard of care adjuvant therapy, approximately 30% of HR+ breast cancer patients who are initially diagnosed at early stage experience distant relapse with metastases (spread of the cancer from the primary site to other parts of the body).

Thus, there is a critical need to improve the absolute benefit of adjuvant endocrine therapy for HR+ breast cancer patients who are at high risk of disease recurrence.

The study medication abemaciclib is an oral anti-cancer therapy that has shown robust clinical activity in previous Phase 1, Phase 2, and Phase 3 studies of breast cancer patients both as single agent and in combination with standard endocrine (hormone-based) therapy.

 

Two common genes that increase the risk of developing breast and or ovarian cancer are the BRCA 1 and BRCA 2 gene mutations. The National Institute for Clinical and Care Excellence (NICE) in their guidance to the NHS suggest that carriers of either gene mutation are at high risk of future disease and suggest certain preventative options should be available. These range from increased surveillance through MRI and ultrasound scans, to therapeutic drug interventions, to preventative surgery to remove breast tissue or ovaries. Research supports the risk reducing effects of surgery but as a proportion of carriers may never develop disease NICE does not prescribe a best option. With no objective best intervention the subjective view of the carrier during and after their choice making has been widely studied in terms of decisional conflict, satisfaction and regret. National Health Service (NHS) guidance promotes the value of supportive partners, friends and family in this choice making yet little research has addressed the role of the support person and their influence on the carrier along their journey from genetic testing to their risk reducing intervention decisions. This study seeks to address the research question: Excluding health professionals, what role do others play in the decisions BRCA1/2 carriers make about their risk reducing options? Using a qualitative design this study seeks to conduct semi structured interviews with adults identified by previous patients of the Royal Surrey County Hospital carrier clinic as their support person. The South West Thames Genetics Service and the carrier clinic at the hospital believe greater understand of the support persons role will improve their service. In addition, themes emerging from this study would inform the design of a later prospective study of new service users and their support person entering the carrier clinic.

This research is about measuring the impact of cancer and its treatment on patients and their informal caregivers (e.g. spouse, partner, family member, close friend). Having cancer can affect many aspects of life such as finances, work status and patients’ own caring roles with family or friends, which are important to understand but are not well captured by existing measures.
In studies 1-3 of PROACT we developed and evaluated two questionnaires measuring impact on caregiving and other responsibilities and lifestyle disruption for patients and caregivers. We developed the questionnaires through qualitative interview studies and through collaboration with advisors with lived experience of cancer or caring for someone with cancer. We then conducted some research to determine the reliability and validity of the new measures.
These comparisons are important to ensure that when health care professionals and researchers use our questionnaires, they can be confident that they are measuring wellbeing and impact with a reliable measure. Both
questionnaires performed well in this initial evaluation. In this fourth study we wish to repeat the evaluation with a new group of patients and caregivers. We will expand our inclusion criteria to include different types and stages of cancer. We will use the same methodology as study 3 and invite participants to complete the new PROACT measures three times over two months, along with other quality of life questionnaires at two of these time points. This enables us to see how our new measures perform over time; whether they are reliable if completed twice close together and whether they are able to detect change in wellbeing if completed two months apart in participants whose situations are changing. This next stage in validation is essential to ensure that the questionnaires are suitable for use in future research and practice across different types of cancer.

www.HORIZONS-HUB.ac.uk

HORIZONS is a cohort study to explore recovery of health and well-being in adults diagnosed with cancer. Experiences and outcomes of cancer treatment and care are changing. A growing number of people are experiencing cancer not as a life-limiting disease, but as a life-changing and long-term condition. There is a growing imperative to understand the changing landscape of cancer and its consequences: as we do so, we will be better able to inform the design and delivery of cost effective interventions that make possible supported self-management, as well as service organization and delivery.
The key research questions are:
What impact does cancer and its treatment have on the lives of people diagnosed with cancer in the short, medium and long term?
What are the health outcomes, experiences and self-management activities over the life-course across different cancer types and who and what influence these?

HORIZONS is a series of prospective cohort studies of adults treated for non-metastatic cancer to capture their health outcomes and experiences from before they begin active treatment and regularly over their life-course. Our initial cancer cohorts will be breast cancer (diagnosed under age 50), non-Hodgkin lymphoma, and gynaecological cancers (ovarian, cervical, uterine). We will start recruitment with three pilot sites in NHS Trusts before rolling out full recruitment to approximately 50 NHS secondary care Trusts. Questionnaires will be completed before treatment (baseline), and followed up at regular intervals.

We will maintain and develop HORIZONS as a national and international resource to explore consequences of different cancer diagnoses and treatments from the individual perspective across the life-course.

©2018 Royal Surrey County Hospital

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