title: A Randomized controlled trial to evaluate the impact of a Nurse Navigator Programme on outcomes of people with breast cancer: study protocol.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Manipal College of Nursing, Manipal University, India.
authors.forename: Shejila
authors.identifier: http://orcid.org/0000-0003-0732-8802
authors.initials: S
authors.lastname: Chillakunnel Hussain Rawther
authors.affiliation: Manipal College of Nursing, Manipal University, India.
authors.forename: Mamatha Shivananda
authors.identifier: http://orcid.org/0000-0001-9038-3014
authors.initials: MS
authors.lastname: Pai
authors.affiliation: Department of Radiotherapy & Oncology, Kasturba Medical College, Manipal University, India.
authors.forename: Donald J
authors.initials: DJ
authors.lastname: Fernandes
authors.affiliation: Department of Surgery, Kasturba Medical College, Manipal University, India.
authors.forename: Stanley
authors.initials: S
authors.lastname: Mathew
authors.affiliation: Department of Statistics, Manipal University, India.
authors.forename: V S
authors.initials: VS
authors.lastname: Binu
authors.affiliation: Manipal College of Nursing, Manipal University, India.
authors.forename: Jyothi
authors.initials: J
authors.lastname: Chakrabarty
authors.affiliation: Manipal College of Nursing, Manipal University, India.
authors.forename: Elsa Sanatombi
authors.initials: ES
authors.lastname: Devi
authors.affiliation: Manipal College of Nursing, Manipal University, India.
authors.forename: Anice
authors.initials: A
authors.lastname: George
authors.affiliation: Manipal College of Nursing, Manipal University, India.
authors.forename: Baby S
authors.initials: BS
authors.lastname: Nayak
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000517:prevention & control; D001291:Attitude of Health Personnel; D001943:Breast Neoplasms / Q000451:nursing* / Q000523:psychology*; D005260:Female; D006801:Humans; D007194:India; D008875:Middle Aged; D009732:Nursing Care / Q000523:psychology*; D009741:Nursing Staff, Hospital / Q000523:psychology*; D010353:Patient Education as Topic; D010361:Patients / Q000523:psychology*; D011788:Quality of Life / Q000523:psychology*; D013315:Stress, Psychological; D011795:Surveys and Questionnaires
keywords: Nurse Navigator Programme; anxiety; breast cancer; depression; nursing intervention; psychological distress; quality of life; supportive care