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CTRI Number  CTRI/2022/02/040098 [Registered on: 08/02/2022] Trial Registered Prospectively
Last Modified On: 16/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on self body image issues and assessment of overall well being among women after breast cancer surgery in a cancer centre of kolhapur 
Scientific Title of Study   A study on body image and assessment of quality of life among women after mastectomy operated in a semi urban Cancer centre of Kolhapur. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashmee Kalas 
Designation  Post graduate student (MPH final semester) 
Affiliation  Prasanna School of Public health 
Address  Room number 61,Prasanna School of Public Health, Manipal University,Madhav nagar,Manipal

Udupi
KARNATAKA
576104
India 
Phone  7218036206  
Fax    
Email  kalasrashmee@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrKumar Sumit 
Designation  Assistant Professor- senior scale 
Affiliation  Prasanna School of Public Health 
Address  Room number 53,Prasanna School of Public Health, Manipal University, Madhav nagar,Manipal

Udupi
KARNATAKA
576104
India 
Phone  8867620088  
Fax    
Email  kumar.sumit@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kumar Sumit 
Designation  Assistant Professor- senior scale 
Affiliation  Prasanna School of Public Health 
Address  Room number 53,Prasanna School of Public Health, Manipal University, Madhav nagar,Manipal

Udupi
KARNATAKA
576104
India 
Phone  8867620088  
Fax    
Email  kumar.sumit@manipal.edu  
 
Source of Monetary or Material Support  
Kolhapur Cancer Centre, Kolhapur 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Ms Amla Kamble  Kolhapur Cancer Centre  Room number 6,Survey No 238, Gokul Shirgaon Midc, Opposite Mayur Petrol Pump Near Orange Dhaba, Kolhapur, Maharashtra 416234
Kolhapur
MAHARASHTRA 		 7030860303

amla.kamble88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
Kolhapur Cancer Centre Ethical commitee  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Recovered breast cancer patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Women who have undergone unilateral/ radical/ bilateral/ conservative mastectomy in the past five years in Kolhapur cancer center, Kolhapur. 
 
ExclusionCriteria 
Details  1. Women who have undergone any breast reconstruction surgery post mastectomy.
2. Women with a history of psychiatric disorder.
3. Women with any other health problem that could affect the body image.
4. Women with other cancer, in present or past.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will provide assessment on the psychological distress faced by women post-surgery.   4 to 5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The study will generate evidence at the local level to improvise awareness and psychological help seeking behavior among the target population   15 to 16 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="136" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/02/2022 
Date of Study Completion (India) 31/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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)?  

Response - NO
Brief Summary   Breast cancer is one of the four most frequent types of cancer seen in women and the second leading cause of death from cancer. Mastectomy is the surgical treatment of breast cancer. It results in a permanent change in the appearance of women. The breast is considered a part of a woman’s identity in Indian culture. It represents femininity, sexuality, beauty, and motherhood. The perceived loss of any of these attributes may lead to a negative change in body image and influence the quality of life of women. The contact details of women who have undergone mastectomy in the past 5 years from Kolhapur Cancer Centre will be retrieved from the hospital registry. Recall patients that are normally being called in the hospital for follow-up will be asked for consent. After receiving the consent, face to face interviews will be arranged in a specific room of the hospital. A FACT B questionnaire will be used to assess the quality-of-life index from the respondents. Among these same respondents, selective respondents will be asked consent for the in-depth interview.
In depth interviews will be arranged to understand the body image issues faced by the respondents using an in-depth interview guide. 
 The current study findings will suggest that mastectomy as a surgical treatment for breast cancer may negatively affect a woman’s body image and her self-image. Additionally, it will give information on its impact on the quality of life of women. Hence, this study will be conducted to gain a holistic understanding of the negative body image and impact of mastectomy on the quality of life of women. It will also encourage the practice of undergoing breast reconstruction following mastectomy.
 
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