| CTRI Number |
CTRI/2024/02/062342 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Mental Health and Well-being in Women with Gynecological Cancers in Udupi, Karnataka |
|
Scientific Title of Study
|
Study on psychological distress and health related quality of life among women with gynecological cancers at a tertiary care hospital in Udupi, Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Pinto |
| Designation |
II year MPH student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Master of Public Health student Department of Health Policy Room
Number 50 Prasanna School of Public Health Manipal Academy of
Higher Education Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9481259431 |
| Fax |
|
| Email |
poonamppinto@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varalakshmi Chandra Sekaran |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health MAHE Manipal |
| Address |
Room no. 50 Department of Health Policy, PSPH, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535810325 |
| Fax |
|
| Email |
varalakshmi.cs@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varalakshmi Chandra Sekaran |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health MAHE Manipal |
| Address |
Room no. 50 Department of Health Policy, PSPH, MAHE, Manipal
KARNATAKA
576104
India |
| Phone |
9535810325 |
| Fax |
|
| Email |
varalakshmi.cs@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Poonam pinto |
| Address |
Master of Public Health student Room Number 51 Department of
Health Policy Prasanna School of Public Health Manipal Academy of
Higher Education Manipal Udupi district 576104 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Poonam Pinto |
Prasanna school of Public Health |
room no 50 Department of Health Policy Prasanna school of Public Health Manipal Academy of Higher Education
Udupi
KARNATAKA |
9481259431
poonamppinto@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC KH IEC-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 years above diagnosed with cervical and ovarian cancer at tertiary Hospital
Women with stages 1 and 2 and 3 of cervical and ovarian cancer who are both in-patients and out-patients at tertiary hospital
|
|
| ExclusionCriteria |
| Details |
Patients with a history of psychiatric disorder
Stage 4 of all the cervical and ovarian cancer and who are critically ill irrespective of their stage of cancer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study aims to evaluate psychological distress in women with gynecological cancers. |
3 months from data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study assess health-related quality of life in women with gynecological cancers. |
3 months from data collection |
|
|
Target Sample Size
|
Total Sample Size="292"
Sample Size from India="292"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
06/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to asses level of psychological distress and health related quality of life among women with gynecological cancers. This study will use validated tools, Kessler Psychological Distress Scale (K10) and EORTC QLQ-C30, to assess psychological distress and health-related quality of life in gynecological cancer patients of stages 1 to 3. The study will focus on 292 women, aged 18 and above, diagnosed with cervical and ovarian cancer at a tertiary hospital, However, they won’t include patients with a history of psychiatric disorders or those in stage 4 of cervical or ovarian cancer, regardless of their critical condition. Patients from both in-patient and out-patient settings will be interviewed privately after obtaining consent and explaining the study. Researchers will administer the questionnaires, ensuring confidentiality. The collected data, gathered in a single session, will be analyzed using suitable statistical methods. This study intends to explore the psychological distress levels in women with gynecological cancers, focusing on anxiety and depression. Additionally, it aims to evaluate the health-related quality of life by asking about their physical and mental well-being.
|