Contact information
Type
Scientific
Primary contact
Ms Noreen Cushen
ORCID ID
Contact details
Galen House
The Princess Alexandra Hospital NHS Trust
Hamstel Road
Harlow
CM20 1QX
United Kingdom
+44 (0)1279 694937/28
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0255127859
Study information
Scientific title
The psychological effects of completing daily diary cards for patients receiving chemotherapy
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Signs and Symptoms: Nausea and vomiting
Intervention
Daily diary cards vs standard practice
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Hospital Anxiety and Depression (HAD) questionnaire
2. Rotterdam Symptom CheckList (RSCL)
3. Diary cards
Secondary outcome measures
Not provided at time of registration
Overall trial start date
08/09/2003
Overall trial end date
08/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patient receiving chemotherapy and using daily diary cards
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
68
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
08/09/2003
Recruitment end date
08/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Princess Alexandra Hospital NHS Trust
Harlow
CM20 1QX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Princess Alexandra Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary