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:
  1. Type of Surgery: Mastectomy or Breast Conservation
  2. Regional Nodal Radiation: Required or Not
  3. Triple Negative Breast Cancer: Yes or No
  4. 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.