| CTRI Number |
CTRI/2024/05/067523 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality Of Life Assessment in Breast Cancer. |
|
Scientific Title of Study
|
LONG TERM PATIENT REPORTED OUTCOME OF SURGERY IN NON METASTATIC BREAST CANCER PATIENTS |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suhani |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines, Surgery Block, All India Institute of Medical Sciences, Ansari Nagar-East, New Delhi
Central
DELHI
110029
India
Central
DELHI
110029
India |
| Phone |
9868397697 |
| Fax |
|
| Email |
drsuhani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhani |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Surgical Disciplines, Surgery Block, All India Institute of Medical Sciences, Ansari Nagar-East, New Delhi
Central
DELHI
110029
India
Central
DELHI
110029
India |
| Phone |
9868397697 |
| Fax |
|
| Email |
drsuhani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saswatee Prajna Sahoo |
| Designation |
Junior Resident ( Academic) |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
Department of Surgical Disciplines,Surgery Block, All India Institute of Medical Sciences, Ansari Nagar- East, New Delhi
Central
DELHI
110029
India
Central
DELHI
110029
India |
| Phone |
8249454524 |
| Fax |
|
| Email |
sahoosaswateeprajna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines, Surgery Block, All India Institute of Medical Sciences, Ansari Nagar-East,New Delhi. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Surgery Block, All India Institute of Medical Sciences, Ansari Nagar-East,New Delhi. PIN - 110029 |
| Type of Sponsor |
Government 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 |
| Dr Suhani |
All India Institute of Medical Sciences |
Department of Surgical Disciplines, Surgery Block, Ansari Nagar- East, New Delhi.
PIN - 110029
Central
DELHI
Central
DELHI |
9868397697
drsuhani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 20-65 years who underwent surgery for non-metastatic breast cancer 3 to 6 year ago from their date of enrollment in this study. 2. No clinical evidence of recurrence at the time of inclusion. 3. Patients should have completed their education till 8th grade. 4. Patients who are comfortable in understanding and speaking either Hindi or English. |
|
| ExclusionCriteria |
| Details |
1. Patients who have developed metastasis at the time of study.
2. Patients having concomitant secondary malignancy during study period.
3. Patients having musculoskeletal disorders that affecting their quality of life.
4. Patients who do not give consent to participate.
5. Patient with psychiatry illness that is limiting the comprehension of questionnaire.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The long-term quality of life in patients who underwent mastectomy without reconstruction and breast conservation surgery for carcinoma breast using BREAST Q questionnaire. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison of long-term quality of life following breast conservation surgery and mastectomy using BREAST Q questionnaire.
2. Study about the factors associated with a poor quality of life in these patients . |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
27/05/2024 |
| 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="1"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study aims to investigate the patient-reported outcomes of surgery in non-metastatic breast carcinoma patients who have undergone either breast conservation surgery or mastectomy without reconstruction. Using the validated BREAST-Q questionnaire, a patient-reported outcome measure , the research intends to evaluate and compare the long-term quality of life outcomes in Indian patients. The study will involve a sample size of 210 participants. Through quantitative assessment of BREAST-Q scores and qualitative insights from patient interviews, the research seeks to provide comprehensive insights into the physical, psychosocial, and sexual well-being outcomes post-surgery. |