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CTRI Number  CTRI/2024/09/073535 [Registered on: 06/09/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Quality of life in breast cancer patients 
Scientific Title of Study   Implementing Quality of Life assessment for breast cancer patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhuri Taranikanti 
Designation  Additional Professor, Physiology 
Affiliation  All India Institute of Medical Sciences, Bibinagar. 
Address  Dr. Madhuri Taranikanti, Department of Physiology, All India Institute of Medical Sciences, Bibinagar.

Hyderabad
TELANGANA
500090
India 
Phone  8008366030  
Fax    
Email  madhuri.tarani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhuri Taranikanti 
Designation  Additional Professor, Physiology 
Affiliation  All India Institute of Medical Sciences, Bibinagar. 
Address  Dr. Madhuri Taranikanti, Department of Physiology, All India Institute of Medical Sciences, Bibinagar.

Hyderabad
TELANGANA
500090
India 
Phone  8008366030  
Fax    
Email  madhuri.tarani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhuri Taranikanti 
Designation  Additional Professor, Physiology 
Affiliation  All India Institute of Medical Sciences, Bibinagar. 
Address  Dr. Madhuri Taranikanti, Department of Physiology, All India Institute of Medical Sciences, Bibinagar.

Hyderabad
TELANGANA
500090
India 
Phone  8008366030  
Fax    
Email  madhuri.tarani@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College, Sanathnagar, Hyderabad. 
 
Primary Sponsor  
Name  Dr Madhuri Taranikanti 
Address  Dr. Madhuri Taranikanti, 6D, Coonoor Tower, Hill county, Bachupally, Nizampet Road, Hyderabad, Telangana, 500090 
Type of Sponsor  Other [Self] 
 
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 
Dr Madhuri Taranikanti  ESIC Medical College, Sanathnagar, Hyderabad  Department of Oncology, Department of Physiology, ESIC Medical College, Sanathnagar, Hyderabad - 500038
Hyderabad
TELANGANA 
8008366030

madhuri.tarani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ESIC Medical College & Hospital and ESIC Super Speciality Hospital, Sanathnagar, Hyderabad  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  80.00 Year(s)
Gender  Female 
Details  Women who have been diagnosed with histologically proven breast cancers. 
 
ExclusionCriteria 
Details  Women with any other cancers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of quality of life post breast cancer.  9 months: Analysis of the study to assess quality of life 
 
Secondary Outcome  
Outcome  TimePoints 
Implement these findings for better patient care.  1 year: Including these points as part of management protocol. 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Introduction:  Breast cancer is one of the most commonly diagnosed malignancy in women and is the leading cause of death worldwide. Breast cancer alone is responsible for 30% of newly diagnosed cancer
cases in women with a high probability that one in eight women will develop breast cancer in their lifetime. It has also been established that 14% of cancer-related deaths are attributed to breast cancer (1,2). Cancers in general demonstrate a higher fatigue score and poorer quality of life attributed to physical, psychological and social factors and (3,4). Breast cancer is a distinctive entity as it hampers the physical appearance of the women besides living with the fear of outcome of cancer including recurrence and death (5,6). The choice of treatment like contralateral mastectomy, conservative breast surgery or immediate reconstruction after
mastectomy can also significantly influence the quality of life in survivors (7,8). Depression, fertility-issues, economic burden and other social issues can also affect quality of life (9,10,11). Different tools have been used to assess the quality of life of patients. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires—Core-30 and Breast-23 (QLQ-C30 and QLQ-BR23)—are valid and reliable tools to assess QoL in breast cancer survivors (12,13,14,15). The present study intends to assess the QoL of breast cancer patients as data from this part of the world is scare and there is an ever increasing incidence of
breast cancer patients in India.

Aims and Objectives:
The aim of the study will be to administered to EORTC QLQ-C30 and BR23 questionnaires to breast cancer patients visiting and obtaining treatment at the Oncology Department of ESIC Medical College and Hospital, Hyderabad with the objective to differentiate QoL among
different groups of breast cancer patients in varying stages of the disease
2. To explore the association of different variables with the domains of QoL.

Methodology:
A total of ----Breast cancer patients, managed at ESIC Medical College and Hospital Oncology Unit, with their diagnosis established at least 6 months ago will be eligible to participate in the study. European Organization for Research and Treatment of Cancer Quality of Life
QuestionnaireCore-30 and Breast-23 (EORTC QLQ-C30 & -BR23) will be administered to the patients. Written consent will be obtained from all the participants on a consent form, the purpose of the study was briefly explained to the participants and the strict confidentiality of the
participants’ information was maintained.

The EORTC QLQ-C30 is a 30-item self-administered cancer specific questionnaire designed to measure QOL in the cancer population. The assessment is comprised of nine domains (physical, role, cognitive, emotional, social, fatigue, pain, nausea and vomiting [43]. The EORTC QLQ-BR23 is a 23-item self-administered breast cancer specific questionnaire, usually administered with the EORTC QLQ-C30, designed to measure QOL in the breast cancer population at various stages and with patients with differing treatment modalities. The assessment is comprised of five domains (body image, sexuality, arm symptoms, breast
symptoms, and systemic therapy side effects) [44].

Statistical Analysis:
The results will be expressed as percentages and a ‘t’ test will be performed to know the significance.

Expected Outcome/Hypothesis: Assessment of QoL of Breast cancer patients has the potential to help in clinical decision making, triage patients, referral for treatable issues which are normally overlooked and provide accurate status of their functioning and well being. The study results might help in managing cancer patients better.
The results are also expected to influence healthcare providers to agree that QoL assessments are valuable in practice and hence, increase the acceptablility among them for its routing use. Also, patient acceptability is expected to be good as the contents of the questionnaires are
sensitive to the needs of the patients.
 
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