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CTRI Number  CTRI/2022/05/042558 [Registered on: 13/05/2022] Trial Registered Prospectively
Last Modified On: 01/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Mainstreaming Study 
Scientific Title of Study   Impact of on-demand training & audio-visual aids to improve referral rates for genetic counselling and/ testing at a tertiary cancer centre  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rima Sanjay Pathak 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre, Homi Bhabha National Institute 
Address  Room no. 1128, Homi Bhabha Block, Tata Memorial Hospital, Dr. E. Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9969474000  
Fax    
Email  drrimapathak@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rima Sanjay Pathak 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Room no. 1128, Homi Bhabha Block, Tata Hospital, Dr. E. Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9969474000  
Fax    
Email  drrimapathak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rima Sanjay Pathak 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre 
Address  Room no. 1128, Homi Bhabha Block, Tata Hospital, Dr. E. Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9969474000  
Fax    
Email  drrimapathak@gmail.com  
 
Source of Monetary or Material Support  
Advance Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Mumbai 
 
Primary Sponsor  
Name  Rima Sanjay Pathak 
Address  1128, Homi Bhabha Block, Tata Memorial Hoapital, Dr. E Borges Road, Parel, Mumbai, 400012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rima Sanjay Pathak  Tata Memorial Hospital  Room No. 1128, 11th Floor, Department of Radiation Oncology, Tata Memorial Hospital, Dr. E. Borges Road Parel
Mumbai
MAHARASHTRA 		 9969474000

drrimapathak@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee I Tata Memorial Hospital  Approved 
Institutional Ethics Committee, MPMMMCC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers and Family members of the cancer patients & Physicians 
Patients  (1) ICD-10 Condition: C419||Malignant neoplasm of bone and articular cartilage, unspecified, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: C729||Malignant neoplasm of central nervous system, unspecified, (4) ICD-10 Condition: C499||Malignant neoplasm of connective and soft tissue, unspecified, (5) ICD-10 Condition: C759||Malignant neoplasm of endocrine gland, unspecified, (6) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, (7) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, (8) ICD-10 Condition: C969||Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Baseline Patient Awareness  In the 3 months leading up to the launch of the patient educational material, eligible patients in the waiting areas and those that visit the CGC would be surveyed on their knowledge, attitudes and expectation on germline mutation testing and inherited cancers 
Comparator Agent  Baseline Physician Awareness  A self-assessment questionnaire would also be provided along with the proficiency test to know the cumulative proficiency score. This will again be repeated after the individual has accessed the learning module. A comparison will be made in the pre and post module proficiency score that would help in understanding the impact of the learning material provided using the app.  
Intervention  Patient Awareness  Patients in the OPD and treatment waiting areas would be approached for the survey prior to the intervention. Once the baseline data is collected. A different set of patients would be approached in the same waiting areas to fill the survey. The only change would be that the monitors and televisions would periodically play the audio-visual aids informing them about the basics of genes and genetic mutations and inherited cancers. There would be pamphlets available on the same and these pamphlets and the waiting area would have QR code for accessing the patient information page on the website providing information on hereditary cancers, counselling and testing services available and the need for personalized follow-up and preventive strategies for patients and healthy carriers within the family. They would be encouraged to discuss their queries and concerns regarding the same with their primary care physician or consult the cancer genetics clinic directly. A helpline number would be provided in case of queries and concerns and a genetic counsellor would be in-charge of operating it. 
Intervention  Physician awareness  Physicians and oncologists would be approached as per disease management groups for informing them regarding the study. We would take this opportunity to provide basic information on the genetic syndromes relevant to the disease site they are working in and also provide a brief demonstration of how to use the app developed. The physicians are then expected to voluntarily download the app onto their personal mobile phones and use them. The app will require them to create an account with basic details like the years of oncology training, age, last educational degree, medical branch and area of expertise and email id. Following this a consent will be requested for participation in the study and for using the background analytics data for improving the user experience and further development of the module. Physicians can access the training modules and will be required to take the pre and post training short surveys to test their proficiency. The proficiency in knowledge of heritable genetic diseases and the testing and counselling would be tested prior to accessing the learning modules by providing a set of 5 questions related to the topic. A self-assessment questionnaire would also be provided along with the proficiency test to know the cumulative proficiency score. This will again be repeated after the individual has accessed the learning module. A comparison will be made in the pre and post module proficiency score that would help in understanding the impact of the learning material provided using the app.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.99 Year(s)
Gender  Both 
Details  Inclusion Criteria (Patients/ Caregivers)
1. Patients and or their caregivers from the breast, gynecology, pediatric, central nervous system and colorectal disease management group who are ≥18 years of age and willing to participate in the study
2. Parents or caregivers of the pediatric patients
3. Can read at least 1 language in which the written informed consent and pamphlets are provided
4. Patients who have a confirmed diagnosis of cancer OR healthy individuals who are suspected or known carriers of a pathogenic variant in a cancer predisposing gene
5. Patients who can understand the language in which the survey is conducted and in which the information is provided in the pamphlets and/ the audio-visual aids


Inclusion criteria (Physicians):
1. All physicians participating in the care of cancer patients and willing to consent for participation in the study and
2. All those that agree to allow access to their background analytics data and
3. Working at the Tata Memorial Centre
 
 
ExclusionCriteria 
Details  Exclusion Criteria (Patient/ Caregivers):
1. Those who have a life expectancy of ≤3 months
2. Pediatric patients younger than 18 years of age
3. Those who cannot understand written or spoken language in which the survey is served and the information is provided.
4. Those who cannot read the languages in which the pamphlets are provided.


Exclusion Criteria (Physicians):
1. Those who do not permit access to their background analytics data

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Objective (Patients):
1. Determine the impact of audio-visual aids and pamphlets on the awareness, attitudes and expectation of the patients

Primary objective (Physicians):
1. Evaluate the impact of the cancer genetics training module on the referral rates and patterns of referrals to the cancer genetics clinic at the Tata Memorial Centre for 3 months after the planned intervention 		 Baseline will be recorded 3 months prior to the intervention and )providing educational material) and for 3 months after providing the intervention (educational material) 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective (Patients):
1. Develop the audio-visual aids and pamphlets in Hindi, English, Marathi the commonly spoken languages for patients at TMC
2. Impact of intervention on the genetic testing acceptance rates among the patients and their family members
3. Impact on the compliance to surveillance protocols among the mutation carriers
4. Evaluate the utility of the information aids developed for the patients


Secondary Objective(s):
1. Design and implement a mobile/ web-based hybrid application for healthcare professionals
2. Evaluate the user behavior within the application by using background analytics
3. Evaluate the improvement in the knowledge of healthcare professionals before and after training
4. Report the utility and user satisfaction
5. Identify factors associated with long term usage of the app
 		 3 months before providing educational material and for 3 months after providing educational material 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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)   31/05/2022 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study will help to design audio-visual aids, educational videos and patient information leaflets for improving patient awareness. As a part of this study, we would also develop a mobile application for physicians that provides basic information on genetic counselling, indications for testing and syndrome specific clinical characteristics which will allow physicians to identify patients who may have a predisposition to hereditary cancers especially in the absence of a family history.

The aim of this study is to improve the rate and the quality of referrals to the cancer genetic clinic at the Tata Memorial Centre. To improve the patient referrals, we would have to improve the awareness levels among both the patient and the physicians to improve the referral rates and their quality. Since we plan to use different interventions for the patients and the physicians, we would conduct them as 2 parallel sub-studies with different objectives and endpoints. Both these studies ultimately would converge to fulfil the aim of the study i.e., to improve the referral rates to the cancer genetics clinic at the Tata Memorial Centre. We would like to evaluate if such interventions help us to improve the rate and quality of referrals to the cancer genetics clinic at the Tata Memorial Centre. 
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