| CTRI Number |
CTRI/2024/01/061374 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assess the well-being of individuals who have undergone breast surgery and chemotherapy for breast cancer, and identify the factors influencing their well being.
|
|
Scientific Title of Study
|
Quality of life and its predictors among patients with breast cancer after surgical and chemotherapy treatment
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moly Thomas |
| Designation |
Assistant Professor |
| Affiliation |
Amala College of Nursing |
| Address |
Moly Thomas, Asst. Professor, Medical Surgical Nursing Department,
Amala College of Nursing,
Amala Nagar P O
Thrissur
KERALA
680555
India |
| Phone |
9633425247 |
| Fax |
|
| Email |
molythomas171989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Moly Thomas |
| Designation |
Asst. Professor |
| Affiliation |
Amala College of Nursing,Thrissur |
| Address |
Moly Thomas,Asst.Professor,
Medical Surgical Department, Amala College of Nursing, Amala Nagar PO
Thrissur
KERALA
680555
India |
| Phone |
9633425247 |
| Fax |
|
| Email |
molythomas171989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Moly Thomas |
| Designation |
Assistant Professor |
| Affiliation |
Amala College of Nursing,Thrissur |
| Address |
Medical Surgical Department,Amala College of Nursing, Amala Nagar PO
Thrissur
KERALA
680555
India |
| Phone |
9633425247 |
| Fax |
|
| Email |
molythomas171989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences Amala Nagar PO Thrissur 680555 Kerala INDIA |
|
|
Primary Sponsor
|
| Name |
Moly Thomas |
| Address |
Assistant Professor, Amala College of Nursing, Amala Nagar PO,Thrissur Dt, Kerala State, 680555 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Moly Thomas |
Amala Institute of Medical Sciences |
Oncology Department,,Sacred Heart Block,first floor, Room number-1, Amala Nagar PO,Thrissur Dt,680555
Thrissur
KERALA |
9633425247
molythomas171989@gmail.com |
| Moly Thomas |
Amala Institute of Medical Sciences |
Amala Nagar PO
Thrissur
KERALA |
9633425247
molythomas171989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amala Institute of Medical Sciences, Thrissur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria
Patients with breast cancer receiving surgical and chemotherapy treatment who are
1. willing to participate in the study
2. Pathologically proven breast carcinoma
3. Planned for receiving minimum 4cycles of chemotherapy before/ after/before and after breast surgery
4. able to speak, read and write Malayalam
5. between the age group of 18 and 70 years
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Patients who are
1. critically ill
2. with metastasis
3. psychiatric or cognitive disorders
4. reported hearing problems
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the quality of life and to determine the predictors of quality of life among patients with breast cancer after surgical and chemotherapy treatment
|
After completing surgical and chemotherapy treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the quality of life between patients undergoing breast conservation and mastectomy surgery |
After completing surgical and chemotherapy treatment |
|
|
Target Sample Size
|
Total Sample Size="422"
Sample Size from India="422"
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)
|
18/01/2024 |
| 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="6"
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
|
This study is a descriptive study to assess the quality of life and identify its predictors among patients with breast cancer after surgical and chemotherapy treatment. After obtaining permission from administrative authority, subjects will be selected according to the inclusion and exclusion criteria from selected oncology departments of tertiary hospitals in Kerala. Informed consent will be obtained from patients with breast cancer receiving surgical and chemotherapy treatments, after a detailed explanation of aim, procedure and participant’s role in the study.The investigator collects the baseline data with the help of a structured questionnaire and the clinical data will be collected by the researcher by using medical records and interview techniques. Then researcher will administer Quality of life questionnaire EORTC QLQ - C30 and EORTC QLQ-BR 23 after completing chemotherapy treatment, ie after finishing four or more cycles of chemotherapy. The primary outcome will be assess the quality of life and identify its predictors among patients with breast cancer after surgical and chemotherapy treatment.Secondary outcome will be compare the quality of life between patients undergoing breast conservation and mastectomy surgery |