Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes