| CTRI Number |
CTRI/2021/06/034128 [Registered on: 10/06/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Patients returning to work after cancer treatment and the problems associated in returning. |
|
Scientific Title of Study
|
Return to work after curative cancer therapy and the barriers associated with it. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMSBIJI |
| Designation |
Assitant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Department of Cancer Palliative Medicine
Room No 162
Kannur
KERALA
670103
India |
| Phone |
09496048807 |
| Fax |
|
| Email |
bijims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BIJI M S |
| Designation |
Assitant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Department of Cancer Palliative Medicine
Room No 162
Kannur
KERALA
670103
India |
| Phone |
09496048807 |
| Fax |
|
| Email |
bijims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BIJI M S |
| Designation |
Assitant Professor |
| Affiliation |
Malabar Cancer Centre |
| Address |
Department of Cancer Palliative Medicine
Room No 162
Kannur
KERALA
670103
India |
| Phone |
09496048807 |
| Fax |
|
| Email |
bijims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar Cancer Centre, P.O Moozhikkara, Thalassery, Kannur - 670103, Kerala |
|
|
Primary Sponsor
|
| Name |
MALABAR CANCER CENTER |
| Address |
Malabar Cancer Centre, P.O Moozhikkara, Thalassery, Kannur - 670103, Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
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 MS BIJI |
Malabar Cancer Center |
Department of Cancer palliative medicine, Room Number 162
Kannur
KERALA |
09496048807
bijims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 20-60 years
2. One year after completing their planned cancer treatment.
3. Those who have been working prior to the diagnosis of their cancer.
|
|
| ExclusionCriteria |
| Details |
Patients who are unwilling to consent for the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| proportion of individual who return to work after completion of their cancer treatment. |
Single, Atleast one year after completion of anticancer treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
22/06/2021 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study involves studying the proportion of cancer survivors who return to work after their definitive treatment ans the barriers associated with their return to work..A total of 200 patients who have been working prior to their cancer treatment would be recruited.This would be a single centre prospective observational study. |