FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076743 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Longitudinal study of quality of life of young women with breast cancer 
Scientific Title of Study   Young Women with Breast Cancer: Assessing the Unmet needs Longitudinally 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tabassum Wadasadawala 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177026  
Fax    
Email  twadasadawala@actrec.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tabassum Wadasadawala 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177026  
Fax    
Email  twadasadawala@actrec.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Chetan Sethiya 
Designation  Junior Resident 
Affiliation  Tata Memorial Centre 
Address  Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  08291761166  
Fax    
Email  sethiyachetan8848@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Tata Memorial Centre, Dr. E Borges Road, Parel, Mumbai - 400 012 India 
Type of Sponsor  Research institution and hospital 
 
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 Tabassum Wadasadawala  Tata Memorial Centre  Department of Radiation oncology, Homi Bhabha building room 105/108, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA 
02224177026

twadasadawala@actrec.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - I  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  40.00 Year(s)
Gender  Female 
Details  To study young patients with breast cancer 
 
ExclusionCriteria 
Details  Not willing to participate. Unable to comprehend questions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the temporal trends in the psychosocial domain of QoL based on FACT-B questionnaire during various phases of therapy and at first follow up compared to baseline  At Baseline, After Surgery, After Chemotherapy, Afer Radiotherapy, 1st Follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
1. To collect longitudinal data about quality of life in young breast cancer patients; 2. To identify unmet needs in patient using the unmet needs inventory (YBC-UNI); 3. To evaluate the fertility related concerns in patients using FertiQOL; 4. To assess the impact of premature ovarian suppression on quality of life using MRS  3 years 
 
Target Sample Size   Total Sample Size="657"
Sample Size from India="657" 
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)   02/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Breast cancer is the most commonly diagnosed cancer among women globally, with 2.3 million new cases in 2020, accounting for 24.2 percent of all female cancer diagnoses. In India, it has surpassed cervical cancer as the leading cancer among women, marking a significant demographic shift. While breast cancer primarily affects older women, younger women under 40 years constitute a notable proportion of cases. Globally, this age group accounts for approximately 7 percent of cases, but in India, the rate is higher, ranging from 9.77 percent to 15–20 percent.

For young breast cancer patients, diagnosis and treatment often disrupt key life stages such as education, career, family planning, and social roles. These patients face unique challenges, including chemotherapy-induced menopause, fertility concerns, body image issues, and balancing personal and professional responsibilities. Their quality of life (QoL) is impacted across physical, psychological, social, and environmental dimensions.

This study aims to evaluate QoL in young breast cancer patients, focusing on unmet needs related to premature ovarian failure and psychosocial concerns. QoL will be assessed at five key time points: baseline (post-diagnosis, pre-treatment), post-chemotherapy, post-surgery, post-radiotherapy, and six months after treatment. Demographic, clinical, and treatment data will be collected using validated tools in English, Hindi, and Marathi to ensure cultural relevance.

The study will employ tools such as FACT-B and FACIT-Sp to assess physical, social, emotional, functional, and spiritual well-being; the Body Image Scale to evaluate body image concerns; the Hospital Anxiety and Depression Scale for anxiety and depression; FertiQOL for fertility-related concerns; and the Menopausal Rating Scale for menopausal symptoms, including chemotherapy-induced amenorrhea.

Conducted over three years with an enrollment target of 657 patients, this study will provide a comprehensive assessment of QoL among young breast cancer patients in India. By addressing physical and psychosocial challenges, it aims to improve survivorship care and address gaps in understanding the unique experiences of this population.

 
Close