| CTRI Number |
CTRI/2022/01/039478 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
15/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study evaluating Symptom and Distress screening tools in initiating early supportive care in cancer patients treated with curative radiation therapy |
|
Scientific Title of Study
|
Prospective study evaluating the role of Symptom and Distress screening tools in initiating early supportive care in cancer patients treated with curative intent radiation therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debnarayan Dutta |
| Designation |
HOD and Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Room Number-6, Block A, Department of Radiation Oncology, Amrita Institute of Medical Sciences, Ponekkara P.O., Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9884234290 |
| Fax |
|
| Email |
duttadeb07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debnarayan Dutta |
| Designation |
HOD and Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Room Number-6, Block A, Department of Radiation Oncology,Amrita Institute of Medical Sciences, Ponekkara P.O., Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9884234290 |
| Fax |
|
| Email |
duttadeb07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debnarayan Dutta |
| Designation |
HOD and Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Room Number-6, Block-A, Department of Radiation Oncology, Amrita Institute of Medical Sciences, Ponekkara P.O., Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9884234290 |
| Fax |
|
| Email |
duttadeb07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Debnarayan Dutta |
| Address |
Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Amrita Nagar, Ponekkara P.O, Kochi, Kerala - 682041 |
| Type of Sponsor |
Private medical 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 Debnarayan Dutta |
Amrita Institute of Medical Sciences |
Room Number-6,Block A,Department of Radiation Oncology, Ponekkara P.O., Kochi, Kerala - 682041
Ernakulam
KERALA |
9884234290
duttadeb07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Review Board, Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients diagnosed with non metastatic cancer of any site planned for treatment with radical intent radiation therapy |
|
| ExclusionCriteria |
| Details |
Previous radiation therapy
Patients planned for treatment with 10 fractions or less
Patients with multiple distant metastases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine mean change in Total ESAS-r score from baseline to RT completion or follow up visit (3 month) |
3 month after RT completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| - To determine mean change in QOL scores (FACT- G , TOI scores) from baseline to 1 or 3 months post RT |
3 months |
| - To determine proportion of patients with moderate to severe distress during radiation therapy |
End of treatment |
| - To determine the proportion of asymptomatic patients on radiation therapy requiring supportive care based on distress score changes |
End of treatment |
| - To determine most frequent distressing symptom |
End of treatment |
| - To determine mean timing of maximum distress from baseline to 6 months post RT |
6 months |
| - To determine the mean change in Anxiety & depression score from baseline to 1 / 3 months post RT |
3 months |
| - To determine the mean change in symptom score because of supportive care using ESAS tool |
6 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
17/01/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is well known that patients diagnosed with
cancers experience significant levels of distress. Surveys have shown that
20-50% of patients show significant distress.
A landmark randomised study
concluded that patients with metastatic non–small-cell lung
cancer, early palliative care ledto significant improvements in both quality of
life and mood when compared to patients receiving standard care. [1]
Various distress screening tools have been used to objectively detect
significant levels of distress. The Edmonton Symptom assessment scale has been
widely used in for many years. [ 2 . 4 , 5 ] The NCCN Distress thermometer
scale has also been recently found to be a simple method to identify patients
at high risk for distress. [ 3]
The use of these distress screening tools is expected to help screen and
identify cancer patients with significant psychosocial as well as physical
distress, so that early initiation of supportive care can be implemented. This
timely intervention could lead to improvement in well being and quality of life
of patient. |