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CTRI Number  CTRI/2020/03/023797 [Registered on: 06/03/2020] Trial Registered Prospectively
Last Modified On: 30/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Quality of life in breast cancer patients undergoing surgery 
Scientific Title of Study   Evaluation of Quality of Life in breast cancer patients undergoing modified radical mastectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aastha Garg 
Designation  Junior Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of General Surgery GMCH Sec 32B

Chandigarh
CHANDIGARH
160031
India 
Phone  9013563434  
Fax  919646121638  
Email  aasthgarg9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Robin Kaushik 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of General Surgery GMCH Sec 32B

Chandigarh
CHANDIGARH
160031
India 
Phone  919646121638  
Fax  919646121638  
Email  robinkaushik@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Robin Kaushik 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of General Surgery GMCH Sec 32B

Chandigarh
CHANDIGARH
160031
India 
Phone  919646121638  
Fax  919646121638  
Email  robinkaushik@yahoo.com  
 
Source of Monetary or Material Support  
Department of General Surgery, Government Medical College and Hospital, Chandigarh 
 
Primary Sponsor  
Name  GMCH 
Address  Sector 32 Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
aastha garg  GMCH  Department of General Surgery GMCH Sector 32
Chandigarh
CHANDIGARH 
9013563434

aasthagarg9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee GMCH Chandigarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  All adult patients presenting with histopathological diagnosis of breast cancer planned for modified radical mastectomy. 
 
ExclusionCriteria 
Details  Patients with recurrent metastatic disease , with serious co-morbidities like ischemic heart disease, hypothyroidism, severe osteoporosis ,documented psychiatric illness and uncontrolled diabetes mellitus. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of life in breast cancer patient undergoing modified radical mastectomy.  Quality of Life at 1 month post-operative 
 
Secondary Outcome  
Outcome  TimePoints 
Change in quality of life in patients undergoing modified radical mastectomy.  Post-operative evaluation after one month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Breast cancer is the most common malignancy in women worldwide.  More than 1.5 million new cases are being diagnosed every year making it  the second most common cancer overall.1 Its incidence is higher in developed nations and also increases with age, Thus post menopausal women are more likely to be diagnosed with this malignancy.2

It is estimated that 1.67 million women were diagnosed worldwide with breast cancer in 2012.3 In India as well the age standardized incidence rates for breast cancer has been increasing 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 The major risk factors for development are patients age, family history, early menarche, late menopause, high body mass index, socio economic status, ethnicity and a genetic predisposition for breast cancer.5

The early signs of breast cancer are self palpable breast lumps and the definitive diagnosis can be made by histopathological examination of core needle biopsy.6,7 Mammography is the best screening tool for early detection. Early detection is the key to a good prognosis and survival.2,3 Treatment of breast cancer could include different therapies like partial or total mastectomy, radiotherapy, and chemotherapy(neo-adjuvant as well as adjuvant) with or without systemic hormonal therapy. Though these modalities are associated with better survival and outcomes they are associated with a negative impact when it comes to quality of life in breast cancer patients and many complications such as pain, fatigue, lymphedema, reduced vaginal lubrication and hot flashes.1 The extent of these symptoms and side effects vary depending on the specific modalities that are used alone or in combination.

Death rates in breast cancer patients have been declining due to early detection and improved treatment which has paved the way for better understanding of quality of life in surviving breast cancer patients.8 Quality of life (QOL) is defined as “an individual’s perception of his/her position in life in the context of the culture and value systems in which he/she lives and in relation to his/her goals ,expectations, standards, and concerns” by the World Health Organization Quality of Life Group.9 Quality of life has become a well- accepted outcome measure for cancer patients and an integral part of cancer patient management.10 It has received increasing attention due to a rising number of new cases, an improved survival rate, and the vital role of the woman in the family.2 It not only focuses on physical complications post treatment but equally weighs the negative and positive impact of different treatments on emotional, social and functional well being.

Quality of life is now viewed as a primary endpoint measure for quality of management and care in oncology practice as it shows the patient’s perception of the impact of cancer diagnosis and treatment on their daily living.

In order to assess the short and long term effects of cancer on the quality of life, several cancer-specific health-related quality of life (HRQL) measures have been developed such as the Functional Adjustment to Cancer Therapy (FACT), the European Organization for Research and Treatment of Cancer (EORTC), the Functional Living Index-Cancer (FLIC), the Cancer Rehabilitation Evaluation System (CaRES), and the Quality of Life in Adult Cancer Survivor Scale (QLACS). These questionnaires focus on all aspects of health of a patient-physical, social, functional and mental health to assess the overall quality of life in surviving cancer patients.

A few questionnaires have been specifically developed for the assessment of the HRQL of breast cancers patients. 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 for Research and Treatment of Cancer core questionnaire and breast module (EORTC BR 3) (Sprangers et al., 1996).9 Previous studies showed that one quarter to one third of breast cancer patients were detected through screening questionnaires to have distress, anxiety, and depression 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 with increased incidence of cancer among younger age group of women.11 With increasing awareness about the treatment modalities and easy availability of resources to administer the treatment increased attention is being given to the Quality of life in these women. While many studies have been conducted on treatment and survival of women suffering from breast cancer, the data on Quality of Life and survivorship is very limited. The present study is planned with the objective to understand and to identify the issues causing maximum limitation in their QOL. This information will help in more targeted intervention and overall in providing better health care facilities to survivors.

 
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