Quality of life in a Neoadjuvant study of chemotherapy versus endocrine therapy in postmenopausal patients with primary breast cancer (NEOCENT)
Principal Investigator: Professor Lesley Fallowfield
Co-investigator (trial Principal Investigator): Professor RC Coombes, Head of Department of Medical Oncology, Imperial College London
Data Manager: Carolyn Langridge
Background and aims
Chemotherapy and hormone therapy are commonly used to treat patients with breast cancer after they have had breast surgery. The purpose of this neoadjuvant study is to assess the value of using these treatments before surgery. This is to try and shrink the breast tumour so that the surgery required may be less extensive (avoiding a mastectomy) or may improve the appearance of the breast after lumpectomy. This trial is designed to establish which of the two treatments is more effective at causing shrinkage, as this is currently unknown.
In the NEOCENT trial women will be randomly allocated to receive chemotherapy or hormone therapy. 40 women from different hospitals in the UK and overseas will be included in the pilot study. If this becomes a full trial more women will take part. The clinical aspect of the trial is being coordinated from the International Collaborative Cancer Group, Imperial College London. They will be looking very closely at the medical effects that patients may experience.
Our Quality of Life arm to the study will look at the effect of treatment on patients' general wellbeing. To see how treatment relates to quality of life over time, patients will be invited to complete 6 questionnaires within the first year, then annually.
The first questionnaire will be completed before starting any treatment (a baseline). The next two are sent to the patient before surgery (12 weeks into treatment and 1 week before surgery), then a month after surgery, 9 months from baseline and 12 months from baseline. The questionnaire may take up to 30 minutes to complete and comprise the following validated components (not all are required for each timepoint):
FACT-B: a 37-item questionnaire assessing the physical, functional, emotional and social well-being of patients with breast cancer concerns.
FACT-Es: a 19-item questionnaire assessing well-being related to possible endocrine symptoms.
FACT-F: a 13-item questionnaire to assess levels of fatigue of patients.
Body Image Scale: a 10-item questionnaire to assess women’s perception of their body image.
Broadbent Cognitive Questionnaire: 25 questions relating to lapses in attention in everyday life, previously used in longitudinal studies examining cognition in women receiving chemotherapy and hormone therapy.
Speilberger State-Trait Anxiety Inventory: 6-item short form questionnaire assessing anxiety which may be related to any cognitive problems.
Additional unvalidated questions about having treatment before surgery and surgical decision-making have also been included.