| CTRI Number |
CTRI/2024/12/078440 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Impact of Radiotherapy on Quality of Life in Breast Cancer Patients Treated at DMIHER, Sawangi (2023–2024) |
|
Scientific Title of Study
|
Assessment and impact in quality-of-life post radiotherpy in breast cancer patients treated at DMIHER, Sawangi 2023-2024 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Induni Nayodhara Weerarathna |
| Designation |
Undergraduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radiotherapy, First floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9822185492 |
| Fax |
|
| Email |
weerarathnainduni5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anurag Luharia |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radiotherapy, First floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9730180151 |
| Fax |
|
| Email |
rs0@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anurag Luharia |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radiotherapy, First floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442107
India |
| Phone |
9730180151 |
| Fax |
|
| Email |
rs0@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Induni Nayodhara Weerarathna |
Acharya Vinoba Bhave Rural Hospital (AVBRH) |
Department of Radiotherapy, First floor, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA |
9822185492
weerarathnainduni5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee Datta Meghe Institute of Higher Education and Research |
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 |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients must be literate and capable of either writing or speaking in Hindi or Marathi, the regional languages.
2.Alternatively, if the patient is not literate, their caregiver must possess a sufficient level of literacy.
3.Participants must have undergone radiotherapy treatment for breast cancer.
4.Patients’ medical records should include details of surgery, chemotherapy, and radiotherapy.
5.Patients or their caregivers must be accessible via telephone for data collection regarding aspects related to their quality of life post-radiotherapy. |
|
| ExclusionCriteria |
| Details |
1.Patients falling outside the specified time frame of the study period (2023 to 2024) will not be considered for inclusion
2.Illiterate patients and those unable to speak or write Hindi or Marathi, the regional languages
2.Patients for whom essential medical data, including details of surgery, chemotherapy, and radiotherapy, are unavailable, will not be included in the study |
|
|
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 patients who have received radiotherapy |
Assessment will be done by the end of six months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify psychosocial challenges |
Assesment will be done by the end of six ,month |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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)
|
15/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The process of breast cancer treatment, especially radiation therapy, frequently alters patients’ lives significantly. It is essential to comprehend how radiation affects breast cancer survivors’ quality of life to improve their overall treatment and well-being. The quality of life among breast cancer patients treated at Acharya Vinoba Bhave Rural Hospital (AVBRH), affiliated with the University Of Datta Meghe Institute Of Higher Education and Research (DMIHER), Sawangi, following radiation therapy is examined in this study during the years 2023–2024.This observational cross-sectional study will be conducted in the Department of Radiotherapy of AVBRH associated with DMIHER, the hospital is situated in the state of Maharashtra, in India, from 2023 to 2024. We will select Breast cancer patients registered in AVBRH at the Radiotherapy department from Jan 2023 to October 2023 and receive treatment in the form of radiotherapy; chemotherapy and radiotherapy. The study will be observational and cross-sectional. This research will take approximately six months. Questionnaires will be distributed on the spot to patients and phone interviews for distant patients will be conducted using an interview checklist. |