| CTRI Number |
CTRI/2024/06/068577 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life in Indian women with Gynecological cancers |
|
Scientific Title of Study
|
Quality of life in Indian women with Gynecological cancers :A Prospective observational study |
| 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 Shikha Nagar |
| Designation |
Junior Resident |
| Affiliation |
Aiims Rishikesh |
| Address |
Obs and Gynae department,level 6,Aiims Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8576838553 |
| Fax |
|
| Email |
nagarshikha437@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Nagar |
| Designation |
Junior Resident |
| Affiliation |
Aiims Rishikesh |
| Address |
Obs and Gynae department,level 6,Aiims Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8576838553 |
| Fax |
|
| Email |
nagarshikha437@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shikha Nagar |
| Designation |
Junior Resident |
| Affiliation |
Aiims Rishikesh |
| Address |
Obs and Gynae department ,level 6, Aiims Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8576838553 |
| Fax |
|
| Email |
nagarshikha437@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims Rishikesh,Virbhadra marg,City- Rishikesh,State-Uttarakhand,Pin Code- 249203 |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
not applicable |
| Type of Sponsor |
Other [] |
|
|
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 |
| Prof Shalini Rajaram |
Aiims Rishikesh |
Obs and Gynae Department ,level 6,Virbhadra marg,Rishikesh,uttarakhand
Dehradun
UTTARANCHAL |
9810704434
rajaram.shalini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences,Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: C541||Malignant neoplasm of endometrium, (3) ICD-10 Condition: C58||Malignant neoplasm of placenta, (4) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients with stage I to IV gynecological cancers including ovarian,uterine,cervical and gestational trophoblastic neoplasia
ECOG performance status 0-2 |
|
| ExclusionCriteria |
| Details |
1.Patients who have been previously treated for any cancer
2.Patients with previous history of psychiatric illness
3. Poor performance status (ECOG more than or equal to 3)
4. Age less than 18 years and more than 65 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of women with psychological problems (anxiety,depression),sexual dysfunction,body image disturbances ,unmet supporive care needs ,health related quality of life issues at diagnosos and at follow up in total cohort and in indiviual cancers |
At diagnosis and 3 to 6 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number & comparison of women with varying grades of severity of psychological problems ,disturbances in sexual quality of life ,body image,unmet supportive care needs & health related quality of life ,issues in entire cohort & indiviual cancers |
At diagnosis & 3 to 6 months follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/06/2024 |
| 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="0"
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 aim of this protocol is to evaluate the quality of life parameters at diagnosis and at follow up in women with gynecological cancers namely ovarian, cervical, uterine and gestational trophoblastic neoplasia. Hypothesis- The gynecological cancers causes significantly impact overall quality of life and with treatment ,it is more likely to improve. |