| CTRI Number |
CTRI/2021/06/034045 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey to assess oncologists opinion on need for assessment of Adolescent and Young Adult (AYA) cancer survivors in India. |
|
Scientific Title of Study
|
A Cross-sectional survey to assess the Oncologists’ opinion on need for a comprehensive assessment of Adolescent and Young Adult (AYA) cancer survivors in India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini Menon |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
203, HBB building, Tata Memorial Hospital Dr.E.Borges Marg, Parel, Mumbai MAHARASHTRA 400012
Tata Memorial Hospital, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24176213 |
| Fax |
|
| Email |
nandini.menon1412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Menon |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
203, HBB building, Tata Memorial Hospital Dr.E.Borges Marg, Parel, Mumbai MAHARASHTRA 400012
Tata Memorial Hospital, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24176213 |
| Fax |
|
| Email |
nandini.menon1412@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini Menon |
| Designation |
Assistant Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
203, HBB building, Tata Memorial Hospital Dr.E.Borges Marg, Parel, Mumbai MAHARASHTRA 400012
Tata Memorial Hospital, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24176213 |
| Fax |
|
| Email |
nandini.menon1412@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital Dr. E. Borges Marg, Parel, Mumbai – 400012 |
| 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 Nandini Menon |
Tata Memorial Centre |
203, HBB building, Tata Memorial Hospital Dr. E. Borges Marg, Parel, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
022-24176213
nandini.menon1412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oncologists practicing in India |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Oncologists practicing in India |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the oncologists’ opinion for assessment of AYA cancer survivors. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/06/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The advancements in treatment strategies for cancer and early diagnosis has led to an increase in the cure rate and an increase in the number of cancer survivors. The Adolescent and Young Adult (AYA) patient is generally defined as an individual 15 to 39 years of age at the time of initial cancer diagnosis. AYA cancer survivors are at increased risk of developing various physical and psychosocial issues which vary from those in older adults. There are very few integrated survivorship programmes for AYA cancer survivors in our country. This is an unmet need. Hence, we decided to conduct a survey to learn the views of oncologists on the need for special assessment of AYA cancer survivors and the barriers to providing care to AYA survivors. The questionnaire has been designed to understand the views of oncologists practicing in India on the need for assessment of AYA cancer survivors. Various oncologists practicing in India will be sent a survey questionnaire through google link. A convenience sample of around 100 participants is calculated. We hope to get a response rate of 80% (80 respondents). Descriptive analysis will be performed using SPSS (the statistical package for social sciences) IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. |