| CTRI Number |
CTRI/2025/11/098157 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Symptom experience, symptom distress and clinical outcome among cancer patient visiting the emergency department |
|
Scientific Title of Study
|
A study to assess symptoms experience, symptom distress and clinical outcomes
among cancer patients visiting the emergency department (ED). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyamala |
| Designation |
MSc Nursing Student |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka India |
| Address |
4th Floor Room no 400 Department of Medical Surgical Nursing Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9108167401 |
| Fax |
|
| Email |
shyamalakulal68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika R Pai |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing Manipal Accademy of Higher Education Manipal Udupi |
| Address |
5th Floor Room no 500 Department of Fundamentals of Nursing Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8867785379 |
| Fax |
|
| Email |
radhika.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Bindhu K M |
| Designation |
Lecturer |
| Affiliation |
Manipal College of Nursing Manipal Accademy of Higher Education Manipal Udupi |
| Address |
2nd Floor Room no 200 Department of Fundamentals of Nursing Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8590148015 |
| Fax |
|
| Email |
bindhu.km@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shyamla |
| Address |
Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104 |
| 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 |
| Dr Prithvishree Ravindra |
kasturba Hospital , Manipal |
Ground Floor Emergency Department,Kasturba Hospital, Manipal, Udupi, Karnataka, 576104,India
Udupi
KARNATAKA |
9035296971
prithvishree.r@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Cancer patients aged 18 years and above
2.Cancer patients currently undergoing cancer treatment (chemotherapy, radiation therapy, surgery, palliative care and support)
3.Those who are willing and interested in participating in the study.
|
|
| ExclusionCriteria |
| Details |
1.Cancer patients visiting the emergency department for any other illness treatment, accident and brought dead. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The purpose of this study is to the identify the symptoms experiences, symptom distress and clinical outcomes among cancer patients visiting emergency department to aid in easy symptom identification and appropriate referrals. |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/12/2025 |
| 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 purpose of this study is to identify the symptoms experienced, symptom distress, and clinical outcomes among cancer patients visiting the emergency department, with the aim of facilitating easy symptom identification and appropriate referrals. A quantitative research approach with a descriptive cross-sectional survey design will be used. The purposive sampling technique will be adopted, and the sample size will be time-bound. The population consists of cancer patients, and the samples include those visiting the emergency department of KH Hospital. Inclusion criteria include patients with cancer aged 18 years and above who are currently undergoing treatment, such as chemotherapy, radiation therapy, surgery, palliative care, and supportive care, and those willing to participate. Exclusion criteria are cancer patients visiting the ED for other illness treatment, accident cases, and brought dead. |