The study is being conducted to evaluate the preference, and safety of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of chemotherapy-related moderate to severe neutropenia of Patients with nonmyeloid malignancies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
first cycle: Auto-HHPG-19K Injection or HHPG-19K Injection second cycle: HHPG-19K Injection or Auto-HHPG-19K Injection
The preference ratio of patients for HHPG-19K and Auto-HHPG-19K , as assessed in the Patient Preference Questionnaire"Considering your overall experience in this study, which administration method do you prefer for drug injection?"
The available options for a participant's response were HHPG-19K, Auto-HHPG-19K, and No preference.
Time frame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
The preference ratio of physicians and nurses for HHPG-19K and Auto-HHPG-19K, according to the question in the "Preference Questionnaire of Physician and Nurse": "Which formulation would you recommend for patient use?"
The available options for a participant's response were HHPG-19K, Auto-HHPG-19K, and No preference.
Time frame: approximately 2 months
Factors influencing patients' preference for HHPG-19K and Auto-HHPG-19K.
According to participants' response in the Patient Preference Questionnaire and the Patient Satisfaction Questionnaire, conducting descriptive summaries of influencing factors, including physical condition, convenience, injection pain, and individual evaluation. The available options for a participant's response in the Patient Satisfaction Questionnaire were No, a little, quite, and extremely. The available options for a participant's response in the Patient Preference Questionnaire were HHPG-19K, Auto-HHPG-19K, and No preference.
Time frame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days).
Factors influencing the preference of physician and nurse for HHPG-19K and Auto-HHPG-19K
Influencing factors were analysed according to the items in the Preference Questionnaire of Physician and Nurse.
Time frame: Evaluation after experiencing at least 3 cases of HHPG-19K injection and 3 cases of Auto-HHPG-19K injection therapy
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The injection experience of patients using HHPG-19K and Auto-HH PG-19K
Conduct descriptive summaries based on the patient's injection experience items in the Patient Satisfaction Questionnaire. The available options for a participant's response in the Patient Satisfaction Questionnaire were No, a little, quite, and extremely.
Time frame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
The proportion of successful administration of HHPG-19K Injection within 24h-72h after the end of chemotherapy drugs.
The proportion was summarized based on the time of HHPG-19K administration for each patient.
Time frame: Evaluation after administration on Day 2 of Cycle 2 (each cycle is approximately 21 days)
Incidence of adverse events Auto-HHPG-19K Injection.
Adverse events were assessed by CTCAE v5.0
Time frame: From screening period to the last follow-up visit(approximately up to 2 months )