| CTRI Number |
CTRI/2021/12/039028 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
29/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing and comparing different training methods of brachtherapy skills for gynecological cancers |
|
Scientific Title of Study
|
Development and comparison of different training methods for gynecological brachytherapy skills development: A skills and training methodology development and assessment initiative |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriya Chopra Sastri |
| Designation |
Professor, Radiation Oncology |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
| Address |
PS 246,2nd Floor, Paymaster Shodhika, Advanced Centre for
Treatment, Research and Education in Cancer (ACTREC) Sector 22,
Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930958309 |
| Fax |
|
| Email |
supriyasastri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Chopra Sastri |
| Designation |
Professor, Radiation Oncology |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
| Address |
PS 246,2nd Floor, Paymaster Shodhika, Advanced Centre for
Treatment, Research and Education in Cancer (ACTREC) Sector 22,
Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930958309 |
| Fax |
|
| Email |
supriyasastri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharath Kumar |
| Designation |
Junior Resident, Radiation Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
HBB-1120, 11th floor,
Homi Bhabha Block,
Tata Memorial Hospital,
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7977073966 |
| Fax |
|
| Email |
drbharathkumar95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Dr. E Borges Road, Parel, Mumbai, Maharashtra 400012 |
|
|
Primary Sponsor
|
| Name |
Applied for funds |
| Address |
Applied for funds |
| Type of Sponsor |
Other [Applied for funds] |
|
|
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 Supriya Sastri |
Tata Memorial Hospital, Advance Centre for Treatment, Research and Education in Cancer |
Room no.L-06,
Paymaster Shodhika,
ACTREC, Sector 22,
Utsav Chowk - CISF
Road, Kharghar, Navi
Mumbai, Raigad,
Maharashtra 410210
Raigarh
MAHARASHTRA |
9930958309
supriyasastri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II, Tata Memorial Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Trainees requiring training for advanced gynec brachytherapy procedures, Radiation onco residents in TMH |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Trainees from PGY1 - PGY6 in radiation oncology.
2. Trainees that attend fellowship or training programmes and wish skill enhancement in brachytherapy
3. Early, intermediate and senior-level practitioners who may wish credentialing for advanced procedures (secondary learning curve). |
|
| ExclusionCriteria |
| Details |
Trainees refusing to consent for formal evaluation of learning curve. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish learning curve by scoring on the assessment parameters in trainees for performing standard brachytherapy procedures. |
3,6,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the outcomes of training in brachytherapy by “standard observational training†and “active training†by setting up workshops and simulation labs to experiment on performing procedure on mannequin models |
3,6,9 months |
| To incorporate augmented reality and virtual reality as aids to improve skills by the use of live telecast of Brachytherapy procedure using camera scopes, digital reconstruction and virtual and augmented reality training sets. |
3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/01/2022 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical cancer is the second most common cancer prevalent in India as well as the second most common cause of cancer-related death in women. The standard of care for the treatment of locally advanced cervical cancer (LACC) is concurrent chemoradiation and brachytherapy. Brachytherapy is an integral component of the treatment of cervical cancer, omission of which is associated with detriment in survival. The cure of cervical cancer depends on the delivery of effective first-line treatment of which brachytherapy is a major component. Therefore, it’s critical that the skills of trainees to perform brachytherapy are appropriately developed. Traditionally, training in brachytherapy was performed by initially observing the procedures followed by assisting procedures and then proceeding to individually performing the procedures. However, in recent years various changes have led to reduction in this hands-on experience, including Almost a 2-3-fold increase in the number of MD trainee positions The present multiphase study is proposed to report on the trainee learning curve using “standard or passive-active†methods and “active training†methods like 1) Simulators and Mannequins 2) Virtual and augment-ed reality-based training and report on its impact on the learning curve. In the first phase of the study, the trainee learning curve will be established with “standard observational training, based on a 54-point assessment scale. In the first year, a baseline learning curve generation will be performed using convenience-based sampling based on a number of residents / trainees to work within clinical rotations within the Gynecology brachytherapy unit. We expect 30-40 residents to participate in the first phase of the study. In the second phase of the study “simulator or mannequin-based training†will be added in addition to standard trainingâ€. For this cohort of trainees (which is expected to be different than the first cohort of residents due to clinical rotation organization), a learning curve will be generated. Unpaired t-test and learning curve slope analysis will be undertaken to see if additional extra simulation-based training helps in the reduction of the number of cases needed to reach the expected level of performance. In the subsequent phase, the study will move to aim 3 where virtual and augmented reality methods will be field-tested first for integration into the learning system and then for incorporation for training at both residents, trainee, and staff levels. Using the performance assessment metrics as enumerated earlier a primary and secondary learning curve will be established. The newer training methods of immersive and experiential training will be initially piloted on trainees but have the potential of being used across multiple environments and training platforms increasing possibilities of training many physicians in high incidence regions. The scientific evidence and learning curve development will also set a benchmark for proficiency requirements at various levels and will in the future allow accreditation of trainees for brachytherapy practice |