Clinical trial NCT04342780: Prevalence of Delayed Chemotherapy Associated Nausea
Official title: Delayed Chemotherapy-induced Nausea: A Multi-center Prevalence Survey in Adult Oncology Patients in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: prevalence
chemotherapy-induced nausea and vomiting
oncology
suportive care
Lead sponsor: St.Gallen University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: ZETUP St. Gallen
name: Dr.-Hans-Altschüler-Stiftung
name: University Medical Center Freiburg
name: Spital Thurgau AG
First posted: 2020-04-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult oncology patients in dayclinics

Brief summary: This study evaluates the prevalence of delayed chemotherapy induced nausea in adult oncology patients in real clinical practice of day clinics.

Detailed description: Chemotherapies are rated to have a high to minimal emetogenic potential in oncology patients. Their potential to induce delayed nausea is supposed to often be higher than their emetogenic potential. However, data on delayed chemotherapy-related nausea are scarce, which is problematic because nausea (a) has a large impact on patients quality of life and treatment decisions, (b) is often underestimated by health care professionals, (c) is less responsive to commonly used antiemetic medication, and (d) may even be different from rates that have been established in controlled clinical trials.

Therefore, the aim of this study is to assess the prevalence of delayed chemotherappy-induced nausea in adult oncology patients in dayclinics.

Eligibility criteria: Inclusion Criteria:

* first day of chemotherapy of a new cycle (any cycle)
* speak and write German
* sign the consent forms

Exclusion Criteria:

* cognitive or linguistic impairments that would significantly impede consent or participation (as assessed by the nurses in charge)
* accompanying radiotherapy;
* pre-existing nausea within three days before the start of the first chemotherapy in this cycle; and
* prior participation in CINrate (each person participates only once)

Primary outcomes:
measure: delayed Nausea
timeFrame: Each patient: each days for 5 days after chemotherapy; recruitment: six weeks
Secondary outcomes:
measure: acute nausea
timeFrame: Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks
measure: acute and delayed vomiting
timeFrame: Each patient: each day for 5 days after chemotherapy; recruitment: six weeks
measure: adherence to antiemetics
timeFrame: Each patient: each day for 5 days after chemotherapy; recruitment: six weeks
measure: antiemetic prescription
timeFrame: Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks
measure: interference of nausea or vomiting with everyday life
timeFrame: Each patient: measured at day 5 after chemotherapy; recruitment: six weeks
measure: patient-related barriers to antiemetics
timeFrame: Each patient: measured at day 5 after chemotherapy; recruitment: six weeks
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: ZeTuP
Study officials:
affiliation: Ostschweizer Fachhochschule St. Gallen
name: Antje Koller
role: PRINCIPAL_INVESTIGATOR
References: