Assignment of interventions:
allocation
Sequence generation {16a}
Stratified randomization using permuted blocks will be used for
randomization. The randomization sequence will be generated using the
Robust Randomization App (available athttps://clinicalresearch-apps.shinyapps.io/rrapp/)
or a similar application and the randomization scheme generated from the
app will be then used with the RedCap Randomization module to generate
the randomization sequence. Patients will be allocated into the two
groups in a 1:1 ratio. The following stratification factors will be
used:
- Type of Surgery: Mastectomy or Breast Conservation
- Regional Nodal Radiation: Required or Not
- Triple Negative Breast Cancer: Yes or No
- Institute
Concealment mechanism
{16b}
Randomization of the patient will be done using the randomization module
implemented in the RedCap randomization module in the study database.
Central randomization will be done to ensure allocation concealment.
Implementation {16c}
After screening and eligibility checks are completed, consenting
patients will be randomized using the randomization module. The
randomization will be done centrally at Tata Medical Center. RedCap
provides a data access group feature which ensures that randomization is
stratified by the institute. After filling the other stratification
factors, the randomize button will be clicked which will then provide
the arm allocation information. This information is permanently recorded
in the database and cannot be altered in future.