| CTRI Number |
CTRI/2016/11/007490 [Registered on: 24/11/2016] Trial Registered Prospectively |
| Last Modified On: |
23/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
“QUALITY OF LIFE OF Ca OVARY PATIENTS REFEREED FROM PRIMARY OR SECONDARY HEALTH CENTER†|
|
Scientific Title of Study
|
“QUALITY OF LIFE OF Ca OVARY PATIENTS FROM A TERTIARY CARE CANCER CENTER†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti Bajpai |
| Designation |
Associate Professor, Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital, E Borges Marg
Parel Mumbai 12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177287 |
| Fax |
02224177201 |
| Email |
dr_jyotibajpai@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Bajpai |
| Designation |
Associate Professor, Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital, E Borges Marg
Parel Mumbai 12
MAHARASHTRA
400012
India |
| Phone |
02224177287 |
| Fax |
02224177201 |
| Email |
dr_jyotibajpai@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Kembhavi |
| Designation |
Research Manager |
| Affiliation |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital, E Borges Marg Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
yogeshkembhavi1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [observational study] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Bajpai |
Tata Memorial Centre |
Room No 1115 11th Floor Homi Bhabha Block Tata Memorial Centre
Tata Memorial Hospital Dr Ernest Borges Marg
Parel (East) Mumbai – 400 012
Mumbai
MAHARASHTRA |
02224177287
02224177201
dr_jyotibajpai@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Carcinoma of Ovary, (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Female |
| Details |
Ca ovary patients whose age is above 18 years and have consented to undergo treatment at Tata Memorial Centre, after adequate staging workup. |
|
| ExclusionCriteria |
| Details |
• Patients who do not meet the above criteria.
• Patients unwilling to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To detect, the impact of chemotherapy, on the quality of life of Ca Ovary patients treated with curative intent.
2. To detect, the impact of chemotherapy, on the quality of life of Ca Ovary patients treated with palliative intent.
|
The outcome (Quality of life) will be assessed using the questionnaires of Quality of life analysis - European Organization for Research and Treatment of cancer (EORTC) QLQ-C30 and QLQ- OV28 questionnaire to study a quality of life in Ca ovary patients. There will be two subsets, those who are getting treatment with curative intent and the other one with palliative intent which will be separately analyzed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will give us insight about QOL of Ca ovary patients treated at our center. |
QOL will be measure through the quality of life questionnaires(QLQ) i.e QLQ-C30 and QLQ-OV28 at baseline, after surgery, after completion of all chemotherapy cycle, after 3 months of completion of adjuvant chemotherapy and subsequently every 6 months till 2 years(Total 6 assessments of QOL modules). |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/12/2016 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All patients who satisfy the inclusion criteria and sign the informed consent to participate in the study will be served the Quality of Life questionnaires (EORTC QLQ-C30 and QLQ-OV28) in the language which they know (English, Hindi, Marathi). QOL will be measure through the quality of life questionnaires(QLQ) i.e QLQ-C30 and QLQ-OV28 at baseline, after surgery, after completion of all chemotherapy cycle, after 3 months of completion of adjuvant chemotherapy and subsequently every 6 months till 2 years(Total 6 assessments of QOL modules). At the time of each module assessment, we will record patients nutritional parameters like BMI, serum hemoglobin and albumin levels. We will also do chemo-toxicity assessment as and when applicable. The outcome (Quality of life) will be assessed using the questionnaires of Quality of life analysis - European Organization for Research and Treatment of cancer (EORTC) QLQ-C30 and QLQ- OV28 questionnaire to study a quality of life in Ca ovary patients. There will be two subsets, those who are getting treatment with curative intent and the other one with palliative intent which will be separately analyzed. This study will give us insight about QOL of Ca ovary patients treated at our center. |