Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000473561
Ethics application status
Approved
Date submitted
8/11/2006
Date registered
15/11/2006
Date last updated
15/11/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Anti-nausea Medication Survey
Scientific title
Anti-nausea Medication Survey Project- Optimising chemotherapy related nausea and vomiting and assessment of mood and sleep changes in cancer patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer patients under-going chemotherapy 1449 0
Condition category
Condition code
Cancer 1544 1544 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will use 3 questionnaires and a medication diary as a research tool. The 3 questionnaires are the Hospital Anxiety and Depression Scale (HADS); Sleep Questionnaire (SQ) and MASCC (Multinational Association of Supportive Care) Anti-emesis Tool (MAT). The questionnaires will be filled in at 3 different time points. On day 1 of cycle 1 of chemotherapy- the HADS and SQ will be completed. On day 5 of cycle 1 of chemotherapy- the HADS, SQ and MAT will be completed. The day before cycle 2 of chemotherapy- the HADS and SQ will be completed. It is anticipated that the completion of the booklet will take around 30 minutes in total. The patient will have help filling in the diary by the pharmacist who fill in the medications that the patient needs to take. The patient only has to tick a box when they take an anti-nausea tablet.
Intervention code [1] 1437 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2133 0
Hospital Anxiety and Depression Scale score.
Timepoint [1] 2133 0
Assessed day 1 cycle 1 of chemotherapy (baseline), day 5 cycle 1 of chemotherapy (to see if there is an effect from anti-nausea tablets) then the day before cycle 2 of chemotherapy (to compare to baseline).
Secondary outcome [1] 3695 0
Level of sleep disturbance as measured by sleep questionnaire
Timepoint [1] 3695 0
Measured on day 1 and and day 5 of cycle 1 of chemotherapy and the day before cycle 2 of chemotherapy.
Secondary outcome [2] 3696 0
Degree of nausea and vomiting as measured but MAT.
Timepoint [2] 3696 0
Measured on day 5 of cycle 1 of chemotherapy.
Secondary outcome [3] 3697 0
Assessment of anti-nausea tablets taken using information collected from the medication diary which is filled in daily by the patient during cycle 1 of chemotherapy.
Timepoint [3] 3697 0

Eligibility
Key inclusion criteria
:1. Patients starting their first cycle of chemotherapy for any malignancy 2. Patients having first line chemotherapy used in either the adjuvant or metastatic setting.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. New chemotherapy regimens for second or subsequent lines of chemotherapy2. Patients who cannot understand written English3. Patients with a contraindication to the use of dexamethasone4. Patients with a known pre-existing psychiatric condition.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1684 0
Hospital
Name [1] 1684 0
Westmead Hospital
Country [1] 1684 0
Australia
Funding source category [2] 1685 0
Hospital
Name [2] 1685 0
Blacktown Hospital
Country [2] 1685 0
Australia
Funding source category [3] 1686 0
Hospital
Name [3] 1686 0
Nepean Hospital
Country [3] 1686 0
Australia
Primary sponsor type
Individual
Name
Dr Rina Hui is a Medical Oncology Consultant working in the Medical Oncology Department at Westmead Hospital and the Principal Investigator of the trial. She is the overall person responsible for the trial.
Address
Country
Australia
Secondary sponsor category [1] 1486 0
Individual
Name [1] 1486 0
Dr Rachel Shaw (Medical Oncology Advanced Trainee Registrar)
Address [1] 1486 0
Country [1] 1486 0
Secondary sponsor category [2] 1487 0
Individual
Name [2] 1487 0
Sonia Cuan (Specialist Clinical Pharmacist)
Address [2] 1487 0
Country [2] 1487 0
Secondary sponsor category [3] 1488 0
Individual
Name [3] 1488 0
Deirdre D'Souza (Clinical Pharmacist Coordinator)
Address [3] 1488 0
Country [3] 1488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3134 0
Westmead Hospital
Ethics committee address [1] 3134 0
Ethics committee country [1] 3134 0
Australia
Date submitted for ethics approval [1] 3134 0
Approval date [1] 3134 0
20/10/2006
Ethics approval number [1] 3134 0
HREC2006/9/4.9(2430)
Ethics committee name [2] 3135 0
Blacktown Hospital
Ethics committee address [2] 3135 0
Ethics committee country [2] 3135 0
Australia
Date submitted for ethics approval [2] 3135 0
Approval date [2] 3135 0
20/10/2006
Ethics approval number [2] 3135 0
HREC2006/9/4.9(2430)
Ethics committee name [3] 3136 0
Nepean Hospital
Ethics committee address [3] 3136 0
Ethics committee country [3] 3136 0
Australia
Date submitted for ethics approval [3] 3136 0
Approval date [3] 3136 0
20/10/2006
Ethics approval number [3] 3136 0
HREC2006/9/4.9(2430)

Summary
Brief summary
The study aims to clarify whether patients on the first cycle of chemotherapy receiving anti-emetics recommended by international anti-emetic guidelines experience a change in mood (especially anxiety and depression) or sleep disturbance. We would also like to determine if there is a difference between anxiety and depression levels and level of sleep disturbance in patients with different cancer types; particularly breast cancer versus non-breast cancer patients. The final aim is to confirm prescribing compliance with international anti-emetic guidelines and assess the control of both acute (first 24 hours after chemotherapy) and delayed (2-5 days after chemotherapy) nausea and vomiting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27371 0
Address 27371 0
Country 27371 0
Phone 27371 0
Fax 27371 0
Email 27371 0
Contact person for public queries
Name 10626 0
Dr Rachel Shaw
Address 10626 0
Medical Oncology Department
Hawkesbury Road
Westmead Hospital NSW 2145
Country 10626 0
Australia
Phone 10626 0
+61 416 112539
Fax 10626 0
Email 10626 0
[email protected]
Contact person for scientific queries
Name 1554 0
Dr Rachel Shaw
Address 1554 0
Medical Oncology Department
Hawkesbury Road
Westmead Hospital NSW 2145
Country 1554 0
Australia
Phone 1554 0
+61 416 112539
Fax 1554 0
Email 1554 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.