| 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
|
|
|
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
|
|
|
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
|
|
|
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. |