Breast Cancer Haven, Breast Cancer Research UK, Breast Cancer Support, Mindful Based Stress Reduction programme, Measure Yourself Concerns and Wellbeing

Evaluation of the Breast Cancer Haven Programme

The effects of integrating the Breast Cancer Haven Programme with standard medical treatment on psychophysiological outcomes in women with breast cancer

Breast Cancer Haven (BCH) is planning a rigorous evaluation of BCH Programme to provide scientific evidence of its effects on the quality of life of women with breast cancer receiving a standard cancer treatment regime.

This requires a randomised controlled trial of a large number of patients to show any effects. Since such a trial is a big undertaking with large costs, a pilot feasibility study has been carried out involving a small number of patients so that the study design and methods to be used can be tested.

Pilot Feasibility study
The pilot study, generously funded by GlaxoSmithKline (£79,022), is a randomised study in which participants either received the BCH Programme alongside standard medical treatments, or standard medical treatment alone. Recruitment for the study, carried out at Charing Cross and St Mary's Hospitals in London, ran from February 2008 to the end of May 2009.

Quality of life was measured using questionnaires commonly used in studies of patients with cancer, which encompass factors such as mood states, menopausal symptoms, fatigue and stress. Blood and saliva samples were collected from patients in each group to measure immune cell function and levels of cortisol (stress hormone), respectively. To analyse cost-effectiveness, patients were asked to keep a cost diary in which they recorded the medications or medical supplies they had bought, and the number of visits they have made or received from healthcare professionals.
The data collected from the pilot study is currently being analysed. The findings will be used to evaluate factors such as recruitment of patients, their reasons for missing treatments or dropping out of the study, and the suitability of the questionnaires used.

Main study
The findings of the pilot study will be used to determine the design of the main study, which will be a multicentre randomised controlled trial involving all of our Havens and their local breast care units.

Aims:

To evaluate the physical and psychosocial quality of life of women receiving an integrated package of healthcare consisting of the Breast Cancer Haven Programme alongside standard medical treatment, compared to women who receive conventional treatment alone.
To determine whether any effects of the integrated package are associated with changes in immunological and hormonal parameters.
To assess whether there is a potential economic benefit for women receiving complementary therapies alongside conventional treatment.
To assess whether survival rates for women who received the integrated healthcare package are improved compared with those who received conventional treatment only.