MedPath

Developing and comparing different training methods of brachtherapy skills for gynecological cancers

Not yet recruiting
Conditions
Malignant neoplasm of cervix uteri, unspecified,
Trainees requiring training for advanced gynec brachytherapy procedures, Radiation onco residents in TMH
Registration Number
CTRI/2021/12/039028
Lead Sponsor
Applied for funds
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

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria
    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).
Exclusion Criteria

Trainees refusing to consent for formal evaluation of learning curve.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To establish learning curve by scoring on the assessment parameters in trainees for performing standard brachytherapy procedures.3,6,9 months
Secondary Outcome Measures
NameTimeMethod
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 models3,6,9 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

Trial Locations

Locations (1)

Tata Memorial Hospital, Advance Centre for Treatment, Research and Education in Cancer

🇮🇳

Raigarh, MAHARASHTRA, India

Tata Memorial Hospital, Advance Centre for Treatment, Research and Education in Cancer
🇮🇳Raigarh, MAHARASHTRA, India
Dr Supriya Sastri
Principal investigator
9930958309
supriyasastri@gmail.com

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