A Randomized controlled trial to evaluate the impact of a Nurse Navigator Programme on outcomes of people with breast cancer: study protocol

Aim To evaluate the effectiveness of a Nurse Navigator Programme on anxiety, psychological distress and quality of life in people with breast cancer. Background Breast cancer is the most frequently detected malignancy and a major cause of cancer death among women around the world. The lengthy course of illness from initial diagnosis to treatment and subsequent follow-up causes deterioration in physical, psychological and social status among patients. Nurses have a major role in cancer care. As women with breast cancer have to undergo various treatment modalities, continued care by a pivot nurse is thought to enhance treatment adherence. Limited studies have been reported from developing countries on Nurse Navigation Programmes. Design A Stratified Randomized controlled trial with repeated measures. Methods One hundred and twenty newly diagnosed women with breast cancer admitted to surgery wards of a tertiary care hospital in South India will be recruited. (Project funded in Octo"ber 2014). Women are randomly allocated to a control and intervention group. The outcome variables are anxiety, psychological distress and quality of life. Data on outcome measures will be collected at five different time points: before surgery, at discharge, beginning of adjuvant therapy, middle of adjuvant therapy and at the end of adjuvant therapy. Discussion This study may give evidence on the effectiveness of a Nurse Navigator Programme for women with breast cancer. If significant effects were detected, the programme could be integrated into hospital services to improve the patient care.