The psychological effects of completing daily diary cards for patients receiving chemotherapy
| ISRCTN | ISRCTN82960239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82960239 |
| Protocol serial number | N0255127859 |
| Sponsor | Department of Health |
| Funder | The Princess Alexandra Hospital NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Hospital Anxiety and Depression (HAD) questionnaire |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 08/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
The Princess Alexandra Hospital NHS Trust
Harlow
CM20 1QX
United Kingdom
CM20 1QX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
