Quality of life in breast cancer patients undergoing surgery
- Conditions
- Malignant neoplasm of breast of unspecified site,
- Registration Number
- CTRI/2020/03/023797
- Lead Sponsor
- GMCH
- Brief Summary
Breast cancer is the most commonmalignancy in women worldwide. More than1.5 million new cases are being diagnosed every year making it the second most common cancer overall.1Its incidence is higher indeveloped nations and alsoincreases with age, Thus post menopausal womenare more likely to be diagnosed with this malignancy.2
It is estimated that 1.67 millionwomen were diagnosed worldwide with breast cancer in 2012.3 In Indiaas well the age standardized incidence rates for breast cancer has beenincreasing and it was estimated that the number of breast cancer would rise annually from 153,297 in 2011 to 235,490 cases in 2026.4 Themajor risk factors for development are patients age, family history, earlymenarche, late menopause, high body mass index, socio economic status,ethnicity and a genetic predisposition for breast cancer.5
The early signs of breast cancerare self palpable breast lumps and the definitive diagnosis can be made byhistopathological examination of core needle biopsy.6,7 Mammographyis the best screening tool for early detection. Earlydetection is the key to a good prognosis and survival.2,3 Treatment of breast cancer could includedifferent therapies like partial or total mastectomy, radiotherapy, andchemotherapy(neo-adjuvant as well as adjuvant) with or without systemichormonal therapy. Though these modalities are associated with better survivaland outcomes they are associated with a negative impact when it comes toquality of life in breast cancer patients and many complications such as pain,fatigue, lymphedema, reduced vaginal lubrication and hot flashes.1 Theextent of these symptoms and side effects vary depending on the specificmodalities that are used alone or in combination.
Death rates in breast cancer patients havebeen declining due to early detection and improved treatment which has pavedthe way for better understanding of quality of life in surviving breast cancerpatients.8 Quality oflife (QOL) is defined as “an individual’s perception of his/her position inlife in the context of the culture and value systems in which he/she lives andin relation to his/her goals ,expectations, standards, and concerns†by theWorld Health Organization Quality of Life Group.9 Quality of life has become a well- accepted outcome measure forcancer patients and an integral part of cancer patient management.10 Ithas received increasing attention due to a rising number of new cases, animproved survival rate, and the vital role of the woman in the family.2It not only focuses on physical complications post treatment but equally weighsthe negative and positive impact of different treatments on emotional, socialand functional well being.
Quality of life is now viewed as aprimary endpoint measure for quality of management and care in oncologypractice as it shows the patient’s perception of the impact of cancer diagnosisand treatment on their daily living.
In order to assess the short and longterm effects of cancer on the quality of life, several cancer-specifichealth-related quality of life (HRQL) measures have been developed such as theFunctional Adjustment to Cancer Therapy (FACT), the European Organization forResearch and Treatment of Cancer (EORTC), the Functional Living Index-Cancer(FLIC), the Cancer Rehabilitation Evaluation System (CaRES), and the Quality ofLife in Adult Cancer Survivor Scale (QLACS). Thesequestionnaires focus on all aspects of health of a patient-physical, social,functional and mental health to assess the overall quality of life in survivingcancer patients.
A few questionnaires have beenspecifically developed for the assessment of the HRQL of breast cancerspatients. These include the Breast Cancer Chemotherapy Questionnaire (BCQ)(Levine et al, 1988), the Functional Assessment of Cancer Therapy-Breast(FACT-B) questionnaire (Brady et al., 1997), and the European Organization forResearch and Treatment of Cancer core questionnaire and breast module (EORTC BR3) (Sprangers et al., 1996).9 Previousstudies showed that one quarter to one third of breast cancer patients weredetected through screening questionnaires to have distress, anxiety, anddepression following breast cancer’s diagnosis and treatment. Symptoms-pain,fatigue, and insomnia were among the most common symptoms reported.7
In India, breast cancer is the most common cancer among women withincreased incidence of cancer among younger age group of women.11 Withincreasing awareness about the treatment modalities and easy availability ofresources to administer the treatment increased attention is being given to theQuality of life in these women. While many studieshave been conducted on treatment and survival of women suffering from breastcancer, the data on Quality of Life and survivorship is very limited. The present study is planned with the objective tounderstand and to identify the issues causing maximum limitation in their QOL.This information will help in more targeted intervention and overall inproviding better health care facilities to survivors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 30
All adult patients presenting with histopathological diagnosis of breast cancer planned for modified radical mastectomy.
Patients with recurrent metastatic disease , with serious co-morbidities like ischemic heart disease, hypothyroidism, severe osteoporosis ,documented psychiatric illness and uncontrolled diabetes mellitus.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life in breast cancer patient undergoing modified radical mastectomy. Quality of Life at 1 month post-operative
- Secondary Outcome Measures
Name Time Method Change in quality of life in patients undergoing modified radical mastectomy. Post-operative evaluation after one month
Trial Locations
- Locations (1)
GMCH
🇮🇳Chandigarh, CHANDIGARH, India
GMCH🇮🇳Chandigarh, CHANDIGARH, Indiaaastha gargPrincipal investigator9013563434aasthagarg9@gmail.com