|
Brief Summary
|
QUALITY OF LIFE
Health related quality of life is an important outcome measure for cancer patients and an
integral part of cancer patient management. QOL is a phenomenon
which is subjective and there are many
agreed definitions for quality of life . Many definitions have been given but
no definition has received universal acceptance. Cells and Cherin
defined QOL as “Patient’s appraisal of and satisfaction with their current
level of functioning as compared to what they perceive to be possible or
ideal.†Shumaker et al. defined it as “individuals’ overall
satisfaction with life and their general sense of personal well-beinG.â€
While Schipper described it as “A pragmatic day to day, functional
representation of a patient’s physical, psychological and social response to a
disease and its treatment.†World Health Organization defines it as “The
condition of life resulting from the combination of the effects of a complete
range of factors such as those determining health, happiness including comfort
in the physical environment and a satisfying occupation, education, social and
intellectual attainments, freedom of actions, justice, and expression.
Patient
suffering from cancer is affected in different aspects of QOL. Breast
cancer patients undergo psychosocial distress and experience physical changes
that adversely affect their QOL. It generally comprises of physical functioning, psychological
well-being (such as levels of anxiety and depression), and social support. The
breast cancer patients undergo different
type of experiences in different phases of disease process and management
which could include the following
phases: diagnosis, primary treatment, genetic risk and its psychological
management, special issues related to treatment of breast cancer, fear of recurrence
and re-entry to normal living, survivorship, and palliation for advanced cancer.Various
forms of treatment like surgery ,chemotherapy and radiotherapy in these patients can cause physical and
psychological problems that adversely affect patient QOL . Other effects are anger,
grief, suffering, and pain . These patients have difficulty in
accepting the diagnosis of cancer and many have queries about their illness and
prognosis but avoid speaking to their physician.
Because of increase in number of cancer
survivors, Quality-of-life is becoming important for cancer survivors, their
families and care providers. Future advances in cancer treatment will further
heighten the importance of survivorship issues in comprehensive cancer care. Aims and objectives
1.To
assess Quality of life in breast cancer patients .
2. To
assess the impact of socio-demographic; health-related; cancer-related
,surgical procedures and lifestyle
factors on QOL
Research methodology:
Place
of study: Department
of Radiotherapy & Oncology, Post Graduate Institute of Medical Education
and Research, Chandigarh
Definition of population: Histologically
proven breast cancer patients
Study
design: Prospective Hospital- based
study
Inclusion
criteria: All breast cancer patients with histopathological
proof of malignancy .
Exclusion criteria:
1.Comorbid
conditions including uncontrolled cardiovascular, metabolic, pulmonary, or
renal disease, pregnancy, and history of major psychiatric disorder, such as
schizophrenia, bipolar disorder, or substance abuse/dependence, which may
impact QOL.
2.
Metastatic breast cancer.
3.
Residual or Recurrent breast Carcinoma.
4.
Previous history of any other malignancies.
Sample
size: 100 patients
Duration: 1 year
Parameters &
procedures:
Assessment
1.
Detailed history of patient
2.
Clinical Examination
3. Assessment
of Quality of life by EORTC-QLQ-C30,
EORTC-QLQ-BR23 questionnaire , EORTC-QLQ-BR45
questionnaire before starting of
treatment, post 1 month , at follow up of 6 months and at 1 year follow up.
Procedures:
Patients will be enrolled during their registration.
Subjects who will express interest will be given a copy of consent form along
with quality of life questionnaire. Patient related, disease related and
treatment related parameters will be noted before starting treatment , post
treatment at 1 month , at follow up of 6 month and at 1 year follow up, as
mentioned 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 of
treatment: Surgery related issues, use
of chemotherapy, use of radiotherapy (EBRT or brachytherapy )
3. Disease status
of subject at present, symptoms related to disease and treatment.
4.Survey
instruments : Quality of life
EORTC-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.
|
|