| Source of record | UK Trials |
| ISRCTN | ISRCTN82960239 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0255127859 |
| Public title | The psychological effects of completing daily diary dards for patients receiving chemotherapy |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Signs and Symptoms: Nausea and vomiting |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics information provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patient recieving chemotherapy and using daily diary cards. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 08/09/2003 |
| Anticipated end date | 08/10/2004 |
| Status of trial | Completed |
| Target number of participants | 68 |
| Interventions | Randomised Controlled Trial - Qualitative and Quantitative.
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. |
| Primary outcome measure(s) | 1. Hospital Anxiety and Depression (HAD) questionnaire
2. Rotterdam Symptom CheckList (RSCL)
3. Diary cards |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The Princess Alexandra Hospital NHS Trust (UK) |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Ms Noreen Cushen |
| Contact details | Galen House
The Princess Alexandra Hospital NHS Trust
Hamstel Road
Harlow
United Kingdom
CM20 1QX |
| Contact telephone | +44 (0)1279 694937/28 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82960239 |
| Date last extracted from ISRCTN register | 17/04/2008 |
