The psychological effects of completing daily diary cards for patients receiving chemotherapy
| ISRCTN | ISRCTN82960239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82960239 |
| Secondary identifying numbers | N0255127859 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Noreen Cushen
Scientific
Scientific
Galen House
The Princess Alexandra Hospital NHS Trust
Hamstel Road
Harlow
CM20 1QX
United Kingdom
| Phone | +44 (0)1279 694937/28 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The psychological effects of completing daily diary cards for patients receiving chemotherapy |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Nausea and vomiting |
| Intervention | Daily diary cards vs standard practice |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 08/09/2003 |
| Completion date | 08/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 68 |
| Key inclusion criteria | Patient receiving chemotherapy and using daily diary cards |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 08/09/2003 |
| Date of final enrolment | 08/10/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Princess Alexandra Hospital NHS Trust
Harlow
CM20 1QX
United Kingdom
CM20 1QX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
The Princess Alexandra Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
