| CTRI Number |
CTRI/2024/09/074079 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assess quality of life of patients undergoing Radiation Therapy with different types of cancers |
|
Scientific Title of Study
|
A study to Assess quality of life of patients undergoing Radiation Therapy with different types of cancers in selected hospital in Calicut |
| 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 SHEEJA C V |
| Designation |
Professor |
| Affiliation |
MIMS COLLEGE OF NURSING |
| Address |
MIMS COLLEGE OF NURSING
Vadakedathparambu, Puthukode P.O. Karad Road, Azhinjilam, Vazhayur, Ramanattukara, Kerala, India 673633
Malappuram
KERALA
673336
India |
| Phone |
09448388437 |
| Fax |
|
| Email |
sheejavarghese95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHEEJA C V |
| Designation |
Professor |
| Affiliation |
MIMS COLLEGE OF NURSING |
| Address |
MIMS COLLEGE OF NURSING
Vadakedathparambu, Puthukode P.O. Karad Road, Azhinjilam, Vazhayur, Ramanattukara, Kerala, India 673633
Malappuram
KERALA
673336
India |
| Phone |
09448388437 |
| Fax |
|
| Email |
sheejavarghese95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHEEJA C V |
| Designation |
Professor |
| Affiliation |
MIMS COLLEGE OF NURSING |
| Address |
MIMS COLLEGE OF NURSING
Vadakedathparambu, Puthukode P.O. Karad Road, Azhinjilam, Vazhayur, Ramanattukara, Kerala, India 673633
Malappuram
KERALA
673336
India |
| Phone |
09448388437 |
| Fax |
|
| Email |
sheejavarghese95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aster MIMS Hospital
Mini Bypass Road
Govidapuram P.O.
Kozhikode
Kerala 673016 |
|
|
Primary Sponsor
|
| Name |
No Sponsor |
| Address |
No Sponsor |
| Type of Sponsor |
Other [Private Nursing College] |
|
|
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 Sheeja CV |
Aster MIMS Hospital, Calicut |
Aster MIMS Hospital Oncology Radiation Department, OPD Section
Mini Bypass Road
Govindapuram. P.O.
Kozhikode
Kerala-673016
Kozhikode
KERALA |
9747669936
sheeja.cv@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MALABAR INSTITUTE OF MEDICAL SCIENCES LTD Ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (2) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (3) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Between 18 and 65 years of age
Patients with any type of cancer
Aware of diagnosis
Able to speak, read and write malayalam
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Having speech or hearing problem
Cognitive impairment or psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of Quality of life of cancer patients |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Variations in QoL with different Types of Cancer |
Single point |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
05/03/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
The study will be used to assess the quality of life of patients undergoing radiation therapy for various types of cancer in selected hospitals. The study will be using quantitative research approach with non experimental research design. The variables used in the study will be quality of life. Samples will be selected from Inpatient and outpatient department of radiation therapy at Aster MIMS Hospital, Calicut. Purposive sampling technique will be used to select 60 patients. After getting ethical clearance samples will be explained about the study. Informed Consent and Participant Information Sheet will be given to the patients. WHO Quality of Life questionnaire will be used to collect data. Data will be analyzed using descriptive and inferential statistics. |