Study that only studies information for overcoming barriers and successfully implementing a free-of-cost Blinatumomab (immunotherapy medicine given in treatment of relapsed Acute Lymphoblastic Leukemia) facilitation program in a Low and Middle-Income countries like India

Not yet recruiting

• Conditions: Healthcare professionals involved in delivering Blinatumomab therapy to the patients at the hospital; Encounter for antineoplastic chemotherapy and immunotherapy,

• Registration Number: CTRI/2023/08/056146
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Acute Lymphoblastic Leukemia (ALL) (type of blood cancer) is the mostcommon type of blood cancer. ALL patients that have a partially respondingdisease or relapsed disease are treated with Blinatumomab (immunotherapymedicine) in High Income Countries. It becomes challenging to use this drug in LowMiddle Income Country (LMIC) like India because of the limited resources.Blincyto Humanitarian Access Program (BHAP) has been implemented for theadministration of Blinatumomab supplemented with a training program at TataMemorial Hospital, Mumbai in Pediatric Medical Oncology Department.

This proposed study is going to be conducted in all 3 sites of India andPakistan, wherever BHAP has been implemented. In this study, Blinatumamob teamwill be interviewed at treating centre through a well-structured questionnaire.An online training for the staff involved in Blinatumamob administration hasbeen provided for the administration of program.

Data will be collected centrally by St. Jude’s team.  This study will evaluate the quality of the implementationof the program and will be aimed at assessing resources and training at theimplementing site. It will provide us with more ways to adapt new therapies andtechnologies and pave the pathway for more such therapies to be implemented inLMICs.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-31
• Study Start: 2023-10-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All stakeholders (Healthcare Professionals involved in administration of Blinatumomab) 2.
• All the patients and their caregivers receiving Blinatumomab therapy.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 The barriers & facilitators to blinatumomab implementation in LMIC, including pilot site infrastructure score, climate score & readiness score, & score of perceived intervention complexity	The interviews will be conducted after start of the treatment as the Blinatumomab is ongoing through the Blincyto Humanitarian Access Program, administered to the pediatric patients at baseline and during the therapy, at the end of therapy and 6 months survival data will be collected. Data from care providers will be collected once after initiation of the study at baseline and after providing training at 3 months and after 1 year via web-based systems designed and maintained by St. Jude.
2 The implementation outcomes: feasibility, acceptability, appropriateness, fidelity	The interviews will be conducted after start of the treatment as the Blinatumomab is ongoing through the Blincyto Humanitarian Access Program, administered to the pediatric patients at baseline and during the therapy, at the end of therapy and 6 months survival data will be collected. Data from care providers will be collected once after initiation of the study at baseline and after providing training at 3 months and after 1 year via web-based systems designed and maintained by St. Jude.
3 Relative importance and feasibility of discrete implementation strategies	The interviews will be conducted after start of the treatment as the Blinatumomab is ongoing through the Blincyto Humanitarian Access Program, administered to the pediatric patients at baseline and during the therapy, at the end of therapy and 6 months survival data will be collected. Data from care providers will be collected once after initiation of the study at baseline and after providing training at 3 months and after 1 year via web-based systems designed and maintained by St. Jude.
4 Adequacy of training programs as defined by Training Material Feedback, Provider Specific Knowledge Assessment, and surrogate clinical measures	The interviews will be conducted after start of the treatment as the Blinatumomab is ongoing through the Blincyto Humanitarian Access Program, administered to the pediatric patients at baseline and during the therapy, at the end of therapy and 6 months survival data will be collected. Data from care providers will be collected once after initiation of the study at baseline and after providing training at 3 months and after 1 year via web-based systems designed and maintained by St. Jude.

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Surg Cdr Gaurav Narula

Principal investigator

02224176761

drgauravnarula@gmail.com