| CTRI Number |
CTRI/2023/12/060499 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Presenting symptoms, risk factors and quality of life among ovarian cancer patients |
|
Scientific Title of Study
|
“Assessment of presenting symptoms, risk factors and quality of life among ovarian cancer patients: a cross-sectional survey†|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vina Tina Desouza |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
3rd year BSc Nursing student
Manipal college of Nursing
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7483406987 |
| Fax |
|
| Email |
vina.dsouza@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhika R Pai |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Fundamentals of Nursing
Manipal college of Nursing
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8867785379 |
| Fax |
|
| Email |
radhika.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Radhika R Pai |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Department of Fundamentals of Nursing
Manipal college of Nursing
MAHE, Manipal
KARNATAKA
576104
India |
| Phone |
8867785379 |
| Fax |
|
| Email |
radhika.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Radhika R Pai |
| Address |
manipal college of nursing |
| Type of Sponsor |
Other [Self] |
|
|
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 Karthik Udupa |
Shirdi Saibaba Cancer hospital |
Department of Medical oncology, Manipal Comprehensive Cancer Care Centre, Kasturba Medical College, Manipal
MAHE, Manipal
Udupi
KARNATAKA |
9845317153
udupa.karthik@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C56||Malignant neoplasm of ovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Ovarian cancer patients in Shirdi Saibaba Cancer hospital, KH , Manipal and Daycare.
â– Patients who are keener to participate.
â– Ovarian cancer patients belonging to any age group.
|
|
| ExclusionCriteria |
| Details |
Patients with chronic health issues, mental health problems & uncooperative patients. â– Patients who are unwilling to give the information |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Presenting symptoms
Risk Factors
Quality of Life |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| association between presenting symptoms and quality of life |
1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2023 |
| Date of Study Completion (India) |
30/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/08/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 cross-sectional observational study aimed at assessing presenting symptoms, risk factors, and
quality of life among ovarian cancer patients: a cross-sectional survey in a cancer hospital in India. The primary outcome measures will be the presenting symptoms, quality of life and risk factors in ovarian cancer patients admitted for receiving chemotherapy treatment. |