FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066328 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral
Other (Specify) [smartphone application]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   smartphone application in cancer screening follow-up 
Scientific Title of Study   Effect of Smartphone application on breast self examination practice and adherence to follow-up screening schedule for female cancers: a pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pallavi Shukla 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 136, Preventive Oncology, First Floor, IRCH, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  7042811351  
Fax    
Email  dr.pallavishukla@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Pallavi Shukla 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 136, Preventive Oncology, First Floor, IRCH, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  7042811351  
Fax    
Email  dr.pallavishukla@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Dr Pallavi Shukla 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 136, Preventive Oncology, First Floor, IRCH, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  7042811351  
Fax    
Email  dr.pallavishukla@aiims.edu  
 
Source of Monetary or Material Support  
Research Section, AIIMS, Ansari Nagar, New Delhi, 110029 
 
Primary Sponsor  
Name  AIIMS 
Address  Research Section, AIIMS, New Delhi, 110029 
Type of Sponsor  Research institution 
 
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 Pallavi Shukla  All India Institute of Medical Sciences  Room No 136, first floor, Preventive Oncology, IRCH, AIIMS, Ansari Nagar East
South
DELHI 		 7042811351

dr.pallavishukla@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  common cancer screening 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  smartphone application  prototype android based smartphone application will be developed for assisting in breast self examination and screening follow up reminders 
Comparator Agent  Usual OPD prescription with no additional reminders  No smartphone application. Usual follow-up plan and prescription for breast self examination will be mentioned in their OPD card 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  All newly registered participants of preventive oncology clinic who have consented for breast and/or cervical cancer screening. Age of the participant should be 30-60 years. Those using Android Operating system based smartphones.  
 
ExclusionCriteria 
Details  Previous history of breast or ovarian cancer. Personal or family history of presence of pathogenic trait for breast cancer causing gene. Unable to understand and follow instructions for BSE either due to some physical or mental disability. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
improvement in self breast examination
 		 18-24 months 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in adherence to follow up  18-24 months 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   31/08/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  NIL

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 31-01-2026 and end date provided 31-10-2029?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A randomized control trial to assess the effect of a prototype smartphone application developed for improving the practice of self breast examination and follow-up of common female cancer screening schedule. One group will receive the mobile application, the other will receive the usual care. Total 132 participants will be enrolled, 66 in each arm. participants will be the ones who are visiting the preventive oncology clinic of the institute. The study group will receive the timely reminders as against the control group who will receive the usual OPD card prescription with no additional reminders. Both groups shall recieve the cancer screening services from the preventive oncology clinic. The result of breast self examination practice and adherence to screening follow up will be compared between two groups after 18-22 months of study. 
Close