| CTRI Number |
CTRI/2025/02/081207 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
quasi-experimental |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of a video for educating cancer patients |
|
Scientific Title of Study
|
Development, validation and user-testing of an audio-visual education material for cancer patients undergoing chemotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Allen Pinto |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, (Nitte Deemed to be University), Deralakatte, Mangalore, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9535588221 |
| Fax |
|
| Email |
allen.20upd004@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nandakumar UP |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, (Nitte Deemed to be University), Deralakatte, Mangalore, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633023062 |
| Fax |
|
| Email |
nandakumar@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Krishna Sharan |
| Designation |
Associate Professor and Head, Department of Radiotherapy and Oncology |
| Affiliation |
K. S Hegde Medical Academy |
| Address |
No. 50, Justice K S Hegde Charitable Hospital, (Nitte Deemed to be University) Deralakatte, Mangalore, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448625116 |
| Fax |
|
| Email |
drkrishna.sharan@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Justice K S Hegde Charitable Hospital, Deralakatte, Mangalore, Karnataka, India, Pin:575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 T Krishna Sharan |
Justice K.S Hegde Charitable Hospital, (Nitte Deemed to be University) |
No. 50, Department of Radiotherapy and Oncology, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA |
9448625116
drkrishna.sharan@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients aged above 18 years, presented to undergo their first cycle of chemotherapy.
Patients who can read and understand either English, Kannada or Malayalam languages.
Patients who give their consent for the study. |
|
| ExclusionCriteria |
| Details |
Patients who are critically ill.
Patients with Hematological cancers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is expected to convey the benefits of using Audio-Visual aids in educating cancer patients regarding various aspects pertaining to chemotherapy. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
05/03/2025 |
| 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="0"
Months="6"
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
|
Cancer is a group of diseases affecting millions of people world-wide, posing serious health risks. Chemotherapy is one of the treatment used to treat cancer that requires patients to understand various aspects of the therapy including managing side effects and the importance of adhering to their prescribed regimen. Audio-visual aids provide a dynamic and engaging way to explain complex topics, helping patients understand treatment processes, potential side effects, and learn how to cope with them. This multi-media approach could enhance understanding and memory compared to static written materials.
OBJECTIVES 1. To develop an educational video for cancer patients undergoing chemotherapy and perform its validation and translation. 2. To conduct user-testing of the educational videos developed for cancer patients undergoing chemotherapy
METHODOLOGY It is a Quasi-experimental pre test and post test study without control group which will be conducted in department of Radiotherapy and Oncology, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru. The study will be conducted for a duration of six months from September 2024 to February 2025 on a sample size of 60 patients with cancer who are above 18 years of age undergoing first cycle of chemotherapy and who have given their consent for the study. The audio-visual aids will be prepared in English, Kannada and Malayalam languages. The study will follow Convenience sampling method and the privacy and confidentiality of each participant in the study will be protected. |