A Prospective study to assess the Quality of life (QOL) in breast cancer patients and factors affecting quality of life.

QUALITY OF LIFE

Health related quality of life is an important outcome measure for cancer patients and anintegral part of cancer patient management.QOL is a phenomenonwhich is subjective  and there are manyagreed definitions for quality of life . Many definitions have been given butno definition has received universal acceptance. Cells and Cherindefined QOL as “Patient’s appraisal of and satisfaction with their currentlevel of functioning as compared to what they perceive to be possible orideal.†Shumaker et al. defined it as “individuals’ overallsatisfaction with life and their general sense of personal well-beinG.â€While Schipper described it as “A pragmatic day to day, functionalrepresentation of a patient’s physical, psychological and social response to adisease and its treatment.†World Health Organization defines it as “Thecondition of life resulting from the combination of the effects of a completerange of factors such as those determining health, happiness including comfortin the physical environment and a satisfying occupation, education, social andintellectual attainments, freedom of actions, justice, and expression.

Patientsuffering from cancer is affected in different aspects of QOL. Breastcancer patients undergo psychosocial distress and experience physical changesthat adversely affect their QOL. It generally comprises of  physical functioning, psychologicalwell-being (such as levels of anxiety and depression), and social support. Thebreast cancer  patients undergo differenttype of experiences in different phases of disease process and managementwhich  could include the followingphases: diagnosis, primary treatment, genetic risk and its psychologicalmanagement, special issues related to treatment of breast cancer, fear of recurrenceand re-entry to normal living, survivorship, and palliation for advanced cancer.Variousforms of treatment like surgery ,chemotherapy and radiotherapy  in these patients can cause physical andpsychological problems that adversely affect patient QOL . Other effects are anger,grief, suffering, and pain . These patients have difficulty inaccepting the diagnosis of cancer and many have queries about their illness andprognosis but avoid speaking to their physician.

 Because of increase in number of cancersurvivors, Quality-of-life is becoming important for cancer survivors, theirfamilies and care providers. Future advances in cancer treatment will furtherheighten the importance of survivorship issues in comprehensive cancer care.

Aims and objectives

1.Toassess Quality of life in breast cancer patients .

 2. Toassess the impact of socio-demographic; health-related; cancer-related,surgical procedures and  lifestylefactors on QOL

   Research methodology:

Placeof study: Departmentof Radiotherapy & Oncology, Post Graduate Institute of Medical Educationand Research, Chandigarh

Definition of population: Histologicallyproven breast cancer patients

Studydesign: Prospective Hospital- basedstudy

Inclusioncriteria: All breast cancer patients with histopathologicalproof of malignancy .

Exclusion criteria:

1.Comorbidconditions including uncontrolled cardiovascular, metabolic, pulmonary, orrenal disease, pregnancy, and history of major psychiatric disorder, such asschizophrenia, bipolar disorder, or substance abuse/dependence, which mayimpact QOL.

2.Metastatic breast cancer.

3.Residual or Recurrent breast Carcinoma.

4.Previous history of any other malignancies.

Samplesize: 100 patients

Duration: 1 year

Parameters &procedures:

Assessment

1.    Detailed history of patient

2.    Clinical Examination

3.     Assessmentof Quality of life by EORTC-QLQ-C30,EORTC-QLQ-BR23 questionnaire , EORTC-QLQ-BR45questionnaire  before starting oftreatment, post 1 month , at follow up of 6 months and at 1 year follow up.

 **Procedures:**Patientswill be enrolled during their registration.Subjects who will express interest will be given a copy of consent form alongwith quality of life questionnaire. Patient related, disease related andtreatment related parameters will be noted before starting treatment , posttreatment at 1 month , at follow up of 6 month and at 1 year follow up, asmentioned below:

1.Socio-demographic data: Patients age, educational status, occupation status,age at diagnosis, marital status and household income at the time of diagnosis.

2. Type oftreatment:  Surgery related issues, useof chemotherapy, use of radiotherapy (EBRT or brachytherapy )

3. Disease statusof subject at present, symptoms related to disease and treatment.

4.Surveyinstruments :  Quality of lifeEORTC-QLQ-C30, EORTC-QLQ-BR23(breast cancer module)

Statistical analysis:

The initial data collection will be entered and stored separately in the form of data and coding sheet. The continuous outcome measures will be reported either as means (+/- SD), or median (Inter-Quartile range). The categorical variables will be reported as frequency, proportion or/and median.  Pearson’s correlation coefficient will determine the association between all QOL subscales with age, and time since diagnosis.  Descriptive analysis will be followed by the inferential analysis. The quality of life score with EORTC questionnaire will be assessed by Mann-Whitney test.  Chi-square tests will be used to determine the group differences in categorical outcomes. Multiple linear regression analysis or Multivariable logistic Regression will be used to identify the association of socio-demographic and clinical variables and QOL. All the variables with p≥0.10 in the univariate analysis will be included in regression models. A two-tailed p-value < 0.05 will be used to declare statistical significance in the analysis. Pearson (or Spearman, where appropriate for non-normally distributed measures) correlations will be used to examine the associations between various factors and QOL.