In this case, the randomization method becomes a Simple Block Randomization.
The description of the randomization method in this scenario is as follows:
Randomization method and description of each method:
Simple Block Randomization:
Since the statistical population is homogeneous (all female participants, with non-metastatic breast cancer and regardless of differences in disease severity), there is no need for stratification. In this method, all 80 participants are directly assigned to different groups without considering any stratification. Block randomization is used to maintain a balance in the number of participants during the allocation process.
Block Randomization: All 80 participants are organized into blocks of fixed size (e.g., blocks of 4). Then, in each block, the participants are randomly assigned to the intervention groups (Intervention Group 1, Intervention Group 2, Intervention Group 3) and the control group.
Randomization Unit:
The randomization unit is still Individual. Each of the 80 female participants is individually and randomly assigned to one of the four groups.
Randomization Layers:
In this scenario, there is no layer for randomization.
Randomization Tool:
Statistical Software is used to perform randomization. By entering the total number of participants (80), the number of groups (4 groups), and the block size, the researcher can generate a random sequence of assignments for the entire sample.
How to construct the random sequence:
Determining the block size: The appropriate block size was determined.
Random Sequence Generation: A random sequence of allocations to four groups is generated for all 80 participants using statistical software, taking into account the specified block size. For example, if the block size is 4, the software will generate sequences such as (M1, K, M2, M3), (M2, M3, K, M1), etc. randomly throughout the sequence of 80 participants.
Participant Allocation: Upon entry into the study, each participant is allocated to the corresponding group based on the predetermined random sequence order.
Explanation of Allocation Concealment:
The allocation concealment method will still be sealed and numbered envelopes (SNOSE). The steps for its implementation are also similar to the previous explanation:
Prepare 80 opaque envelopes containing the group allocation for each participant based on the randomly generated sequence.
Envelopes are numbered sequentially from 1 to 80.
Envelopes are completely sealed.
Envelopes are securely stored.
Each participant's envelope is opened by a person not involved in allocation, after eligibility and before the intervention begins.