S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
Kulcsszavak
Absztrakt
Leírás
PRIMARY OBJECTIVES:
I. To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among patients registered at intervention components versus usual care components.
II. To compare the rate of febrile neutropenia (FN) among patients registered at intervention components versus usual care components.
III. To compare the rate of FN among intermediate risk patients registered at intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).
SECONDARY OBJECTIVES:
I. To compare the rate of FN among low-risk patients registered at intervention components versus usual care components.
II. To compare the FN-related health-related quality of life (HRQOL) among low-risk patients registered at intervention components versus usual care components.
III. To compare patient adherence to PP-CSF prescribing among patients registered at intervention components versus usual care components.
IV. To compare patient knowledge of the indications for, efficacy of, and side effects associated with PP-CSF between the initiation and conclusion of the first cycle of myelosuppressive systemic therapy among patients registered at intervention components versus usual care components.
V. To compare the proportion of patients completing the initial systemic therapy regimen at planned duration and at planned dose intensity among patients registered at intervention components versus usual care components.
VI. To compare antibiotic use both as prophylaxis and as treatment for FN among patients registered at intervention components versus usual care components.
VII. To compare the rate of FN-related emergency department visits and hospitalizations among intermediate risk patients registered to Intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).
VIII. To compare the FN-related health-related quality of life (HRQOL) among intermediate risk patients registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).
IX. To compare overall survival among intermediate risk patients registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).
TERTIARY OBJECTIVES:
I. To characterize and descriptively report the differences among cohort components and the intervention and usual care components.
II. To evaluate the time to invasive recurrence in non-metastatic patients by component treatment assignment
OUTLINE: Patients are randomized to 1 of 4 clinic groups.
CLINIC GROUP 1 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN.
CLINIC GROUP 2 (CLINIC WITH NO AUTOMATED SYSTEM): Patients receive CSF based on clinical practice guidelines.
CLINIC GROUP 3 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high or moderate risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN.
CLINIC GROUP 4 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSF not be used for drugs that have a moderate risk of FN.
After completion of study treatment, patients are followed up for 12 months.
Dátumok
| Utolsó ellenőrzés: | 12/31/2019 |
| Első benyújtás: | 03/29/2016 |
| Becsült beiratkozás benyújtva: | 03/29/2016 |
| Első közzététel: | 04/04/2016 |
| Utolsó frissítés beküldve: | 01/14/2020 |
| Utolsó frissítés közzétéve: | 01/17/2020 |
| A tanulmány tényleges kezdési dátuma: | 09/30/2016 |
| Becsült elsődleges befejezési dátum: | 03/31/2021 |
| A tanulmány becsült befejezési dátuma: | 09/30/2021 |
Állapot vagy betegség
Beavatkozás / kezelés
Other: Preventive Intervention
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Fázis
Karcsoportok
| Kar | Beavatkozás / kezelés |
|---|---|
| Experimental: Clinic group 1 (clinic with automated system) Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN. | |
| Experimental: Clinic group 2 (clinic with no automated system) Patients receive CSF based on clinical practice guidelines. | |
| Experimental: Clinic group 3 (clinic with automated system) Patients with a high or moderate risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN. | |
| Active Comparator: Clinic group 4 (clinic with automated system) Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSF not be used for drugs that have a moderate risk of FN. |
Jogosultsági kritériumok
| Tanulásra alkalmas korok | 18 Years Nak nek 18 Years |
| Tanulásra alkalmas nemek | All |
| Egészséges önkénteseket fogad | Igen |
| Kritériumok | Inclusion Criteria: - Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; the current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic - Patients must be registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage 9or disease setting). - Patients must not have had any systemic therapy (chemotherapy or combination regimens) in the 180 days just prior to registration. Prior biologic therapy, immunotherapy, tyrosine kinase inhibitors, and hormonal therapy are allowed. - Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; myelosuppressive therapy must follow the standard regimen, although a dose reduction of up to 10% is permitted. This treatment may be neoadjuvant or adjuvant chemotherapy. - Patients must not be receiving or planning to receive concurrent radiation during systemic treatment. - Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, or tbo-filgrastim - Patients must be able to understand and provide information for the patient-completed study forms in either English or Spanish - Patients may have had a prior malignancy - Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF during their first 6 months after registration - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system |
Eredmény
Elsődleges eredménymérők
1. Change in FN-related HRQL (patient report) assessed using the Functional Assessment of Cancer Therapy -Febrile Neutropenia (FACT-N) [Baseline to up to 14 days]
2. Change in patient knowledge of PP-CSF benefits (patient report) [Baseline to up to 14 days (1 course)]
3. Change in patient knowledge of PP-CSF indications (patient report) [Baseline to up to 14 days]
4. Change in patient knowledge of PP-CSF out-of-pocket costs (patient report) [Baseline to up to 6 months]
5. Change in patient knowledge of PP-CSF risks (patient report) [Baseline to up to 14 days (1 course)]
6. Incidence of febrile neutropenia (clinical) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 [Within 14 days after the completion of first course of therapy]
7. Incidence of febrile neutropenia (clinical) graded according to the NCI Common Toxicity Criteria version 4.0 [Within 6 months]
8. Overall survival (clinical) [Time from date of registration to date of death due to any cause, assessed up to 12 months]
9. Patient adherence to PP-CSF prescription (clinical and patient report) [Within 14 days after the completion of first course of therapy]
10. Prophylactic and FN-related antibiotic use (clinical) [Within 30 days of therapy]
11. Proportion completing initial systemic therapy regimen: a) at planned duration and b) at planned dose intensity (clinical) [Up to 12 months]
12. Rate of CSF prescribing as primary prophylaxis (clinical) [Time from initiation of granulocyte CSFs during the first cycle of myelosuppressive systemic therapy, given 24 to 72 hours after cessation of systemic therapy, assessed up to 12 months]
13. Rate of FN-related emergency department (ED) visits and hospitalizations (clinical) [At 6 months]
Egyéb kimeneti intézkedések
1. Cancer relapse (clinical) only to patients with local or regional disease treated with curative intent [Time from registration to documented invasive local or regional recurrence, assessed up to 12 months]
