A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting
1 other identifier
interventional
92
1 country
1
Brief Summary
The goal of this clinical trial is to investigate the effect of a nurse-led standardized intervention on chemotherapy induced nausea and vomiting (CINV) in patients with head and neck squamous cell carcinoma. The main questions it aims to answer are: (1) what's the best practice to enhance the management of CINV; (2) how's the effect of the nurse-led standardized intervention on CINV in the patients treated with cisplatin-based chemotherapy. Participants in the intervention group will receive evidence-based, nurse-led standardized management of CINV, including nurse-led risk assessment, education on prevention and control of CINV, antiemetics following guidelines, dietary strategies, relaxation therapy, and follow up. Participants in the control group will receive routine care of CINV. The incidence and occurrence degree of CINV and its influence on patients' quality of life will be compared between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 31, 2023
CompletedStudy Start
First participant enrolled
April 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2023
CompletedNovember 14, 2023
March 1, 2023
6 months
March 13, 2023
November 12, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
The incidence of chemotherapy-induced nausea and vomiting
The number of patients who have chemotherapy-induced nausea and vomiting during the first cycle of chemotherapy will be collected.
Five days after administration of cisplatin
The degree of chemotherapy-induced nausea and vomiting
The degree of chemotherapy-induced nausea and vomiting would be assessed by the Common Terminology Criteria for Adverse Events v3.0 during the first cycle of chemotherapy
Five days after administration of cisplatin
The influence of chemotherapy-induced nausea and vomiting on patients' quality of life
The influence of chemotherapy-induced nausea and vomiting on patients' quality of life would be assessed by the Functional Living Index-Emesis during the first cycle of chemotherapy
Five days after administration of cisplatin
Study Arms (2)
The intervention group
EXPERIMENTALThe intervention group will receive evidence-based, nurse-led standardized management of CINV, including nurse-led risk assessment, education on prevention and control of CINV, antiemetics following guidelines, dietary strategies, relaxation therapy, and follow up.
The control group
NO INTERVENTIONThe control group will receive the routine CINV management. Patients are given drugs to prevent and control emesis according to the physicians' individual prescriptions. Nurses provide related education about nausea and vomiting control and recommend patients to drink more water and eat light food. Patients will be given Metoclopramide when they are vomiting.
Interventions
Once the patient in the intervention group decided to undergo cisplatin-based chemotherapy, the nurses would assess the risk factors associated with chemotherapy-induced nausea and vomiting (CINV) and reported to the physicians. During the chemotherapy, nurses would provide education on prevention and control of CINV using web-based approaches. All patients received standard antiemetic regimen, which included Aprepitant, 5-Hydroxytryptamine3-receptor antagonists, and Dexamethasone. If the physician's prescription was not accordance with the standard antiemetic regimen, nurse would remind the physician to adjust the prescription. Patients were recommended to eat small and frequent meals slowly. Overly spicy, fatty, and sweet foods should be avoided. Music relaxation therapy was performed for 60 min each time, once a day, and 3 times in the whole chemotherapy cycle. Follow-up was delivered until the 5th day after chemotherapy.
Eligibility Criteria
You may qualify if:
- diagnosed with head and neck squamous cell carcinoma
- receive first cycle of chemotherapy
- receive cisplatin-based chemotherapy
- able to read and write.
You may not qualify if:
- experience nausea or vomiting in 24 hours before receiving chemotherapy
- mental disturbance
- disturbance of consciousness
- history of stomach disease or surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin medical universtiy cancer institute and hospital
Tianjin, Tianjin Municipality, 300060, China
Related Publications (1)
Cao J, Chen C, Wang Y, Liu M, Han X, Li H. A nurse-led multidomain intervention to improve the management of chemotherapy-induced nausea and vomiting in patients with head and neck cancers: A randomized controlled trial. Eur J Oncol Nurs. 2024 Jun;70:102615. doi: 10.1016/j.ejon.2024.102615. Epub 2024 May 20.
PMID: 38797114DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 31, 2023
Study Start
April 2, 2023
Primary Completion
October 2, 2023
Study Completion
October 12, 2023
Last Updated
November 14, 2023
Record last verified: 2023-03