| CTRI Number |
CTRI/2024/12/077597 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
01/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Survey Study Among Cancer Patients for Assessing the Health Related Quality of Life. |
|
Scientific Title of Study
|
Health Related Quality of Life (HRQoL) assessment using SF-36 Questionnaire in Cancer Patients :A Survey 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 |
Laxmi Narayan Chaudhary |
| Designation |
M.D. Scholar Swasthavritta |
| Affiliation |
Dr. D. Y. Patil College Of Ayurved And Research Centre, Pimpri (Pune) |
| Address |
Opd No. 7,Department of Swasthavritta, Dr. D. Y. Patil College of Ayurved Hospital And Research Centre,Sant Tukaram Nagar,Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9808050890 |
| Fax |
|
| Email |
dr.luckychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Santosh Kamble |
| Designation |
Associate Professor Swasthavritta |
| Affiliation |
Dr. D. Y. Patil College Of Ayurved And Research Centre, Pimpri (Pune) |
| Address |
Opd No. 7,Department Of Swasthavritta, Dr. D. Y. Patil College of Ayurved Hospital And Research Centre,Sant Tukaram Nagar,Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
7057202819 |
| Fax |
|
| Email |
santoshkamble2527@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Santosh Kamble |
| Designation |
Associate Professor Swasthavritta |
| Affiliation |
Dr. D. Y. Patil College Of Ayurved And Research Centre, Pimpri (Pune) |
| Address |
Opd No. 7,Department Of Swasthavritta, Dr. D. Y. Patil College of Ayurved Hospital And Research Centre,Sant Tukaram Nagar,Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
7057202819 |
| Fax |
|
| Email |
santoshkamble2527@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Laxmi Narayan Chaudhary |
| Address |
Opd No. 7,Department Of Swasthavritta, Dr. D. Y. Patil College of Ayurved Hospital And Research Centre,Sant Tukaram Nagar,Pimpri (Pune) Maharashtra-411018 |
| 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 |
| Laxmi Narayan Chaudhary |
Dr. D. Y. Patil College Of Ayurved,Hospital And Research Centre Pimpri Pune 18 . |
Dr. D. Y. Patil College Of Ayurved,Hospital And Research Centre Pimpri Pune 18.Department Of Swasthavritta OPD NO. 7
Pune
MAHARASHTRA |
9808050890
dr.luckychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. D. Y. Patil College of Ayurved and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C801||Malignant (primary) neoplasm, unspecified. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Having been diagnosed with any type of cancer at least more than 1 year
|
|
| ExclusionCriteria |
| Details |
cancer recurrence
pregnancy
neurological and psychiatric disorders or dementia |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SF-36 Questionnaire assessment of cancer Patients on Health related quality of life(HRQoL) |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore factors associated with HRQoL in Cancer Patients |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
16/12/2024 |
| 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
|
|
Survey Study will be
conducted in 126 patients of Cancer for Health-Related
Quality of Life (HRQoL) at different Cancer Hospital/wards in Pune region. The patients will be selected as per inclusion criteria using Convenience Sampling method.
Ethical Clarence
will be obtained from institute.
CTRI registration
will be done prospectively before initiation of survey.
Written Informed consent will be taken from patients before enrollment.
SF-36 Questionnaire (valid and reliable) will be used for
survey study, which is valid, reliable
and data will be generated. Conclusion will be drawn on basis of Statistical analysis.
|
|