"The Role of Diet, Complementary Treatments & Lifestyle in Breast Cancer Survival".
Principal investigator Dr Miriam Dwek (Formerly Dr Anthony J.C. Leathem)
The patient group
Inclusion Criteria
- Under 75
- Grade I-III invasive primary breast cancer
- Approximately 1 year post treatment
Exclusion Criteria
- Previous breast cancer
- Bilateral breast cancer
- Other primary cancer
- Cognitive impairment
- Poor understanding of English
Methods and analysis
Sample size: 3000 patients are needed to demonstrate a significant difference between the groups.
Recruitment
From hospital out-patient clinics around the UK.
Questionnaires
Four types of questionnaires (see below) are issued, once every year for 5 years.
Informed Consent
Obtained from patients after discussion and receiving an information sheet.
Plenty of time is allowed for questions and patients are encouraged to ask as many as they wish.
Blood & Urine
Samples are taken once every year for 5 years.
Blood and urine samples are analysed for a number of markers such as:
- Phytoestrogens
- Phytochemicals
Lifestyle
This is assessed using a fully validated questionnaire which asks a variety of questions about all aspects of life: past medical history and current treatment, job status and educational achievements, smoking, alcohol consumption and many more. This information allows us to construct a complete lifestyle profile of the patient at recruitment. The lifestyle follow-up questionnaire is issued at subsequent visits to identify any changes in the lifestyle and general health of the individual over the following years.
General health questionnaire
This questionnaire asks about how anxious (or not) the individual is feeling and so allows us to assess levels of anxiety and certain elements of stress. These will be analysed using General Health Questionnaire standards.
Food frequency questionnaire
This allows documentation of the frequency of intake of foods over 1 year. It allows us to calculate average intake of food groups and to identify any changes in the nutrition of the individual over a period of time.
7-day food diary
This enables us to calculate exact dietary intake over 1 week as participants are asked to list all food items consumed and briefly describe the preparation of their meals.