A trial investigating the impact of medication review on breast cancer patients in a pharmacy technician led outpatient clinic.
| ISRCTN | ISRCTN99273117 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99273117 |
| Secondary identifying numbers | N0283156787 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 10/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Miss Helena Read
Scientific
Scientific
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
| Phone | +44 (0)1903 285222 x 5698 |
|---|---|
| helena.read@wash.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study hypothesis | To assess whether the introduction of a pharmacy technician led outpatient clinic for breast cancer patients at Worthing Hospital results in an improved level of patient understanding about their chemotherapy support medication. A pharmacy technician clinic will be implemented, the research study will therefore primarily report any benefits of this clinic. Please note that as of 16/09/10 this record has been updated to include information missing at the time of registration. All information has been taken from the published results paper listed in the publications section below. |
| Ethics approval(s) | Added 16/09/10: 1. West Sussex Local Research Ethics Committee approved on the 23rd of November 2004 (ref: 04/Q1911/45) 2. The Sussex NHS Research Consortium approved on the 6th of January 2005 (ref: 0457/WASH/2004) |
| Condition | Breast cancer |
| Intervention | Randomisation into a research or control arm: Group A: attend pharmacy outpatient clinic Group B: usual care |
| Intervention type | Other |
| Primary outcome measure | Level of patient understanding: The chief investigator (HR) interviewed each consented patient using a standard question set, asking the patient to explain what each of their support medications was for and how they used it. Assessments were recorded as an overall rating of the subject's understanding on a Likert scale from 1=very poor to 5=very good, plus a drug-specific score derived from marks awarded for various pieces of information: drug name (+2); indication (+2); dose frequency (+2); dose duration (+1); dose (+1). Thus the maximum score per drug was 8 and the minimum 0. The average score per drug was also calculated. Assessments were conducted prior to randomisation; the chief investigator was blind during subsequent, post-randomisation assessments. |
| Secondary outcome measures | Added 16/09/10: 1. The numbers of patients experiencing delays in receiving their chemotherapy 2. The numbers of patients requiring chemotherapy dose reductions 3. Numbers of patients having potential drug interactions between GP prescribed medication and chemotherapy or chemotherapy support medication 4. The number of chemotherapy support medication items supplied per patient 5. The average cost of chemotherapy support medication supplied per patient 6. The numbers and costs of chemotherapy support medication not supplied 7. The average amount of pharmacy time per patient spent resolving medication issues 8. The numbers of patients requiring a prescription intervention at the point of dispensing |
| Overall study start date | 06/01/2005 |
| Overall study end date | 08/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 140 |
| Participant inclusion criteria | 1. 140 patients being treated for breast cancer and receiving chemotherapy. 2. 18 years and above |
| Participant exclusion criteria | Does not match inclusion criteria |
| Recruitment start date | 06/01/2005 |
| Recruitment end date | 08/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom
BN11 2DH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Sussex NHS Research Consortium (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/03/2007 | Yes | No |
