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ISRCTN
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ISRCTN82960239
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ClinicalTrials.gov identifier
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Public title
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The psychological effects of completing daily diary cards for patients receiving chemotherapy
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0255127859
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Study hypothesis
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There is a relationship between the use of daily diary cards and an increase in the incident of nausea/vomiting and anxiety in patients receiving chemotherapy.
The sample size calculation is based upon RSCL normative data for chemotherapy patients provided in the manual (De-Hanes eta al 1996). This information was not available within the literature for the HAD scale therefore it was decided to base the sample size on RSCL characteristics. Using the normative data from the RSCL manual I assumed: control group mean = 25; standard deviation = 22; treatment group standard deviation = 22. Based
on these assumptions and requiring a statistical power of 0.8; using a 2-sided test at alpha = 0.05 to discern a 15 point difference between treatment and control groups the calculations indicated a sample size of 34 patients per group (total 68) would be sufficient.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Signs and Symptoms: Nausea and vomiting
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Participants - inclusion criteria
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Patient receiving chemotherapy and using daily diary cards.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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08/09/2003
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Anticipated end date
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08/10/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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68
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Interventions
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Daily diary cards vs standard practice
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Primary outcome measure(s)
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1. Hospital Anxiety and Depression (HAD) questionnaire
2. Rotterdam Symptom CheckList (RSCL)
3. Diary cards
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The Princess Alexandra Hospital NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Ms
Noreen
Cushen
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Address
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Galen House
The Princess Alexandra Hospital NHS Trust
Hamstel Road
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City/town
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Harlow
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Zip/Postcode
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CM20 1QX
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Country
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United Kingdom
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Tel
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+44 (0)1279 694937/28
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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08/06/2009
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Date ISRCTN assigned
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30/09/2004
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