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
Protocol serial number	N0283156787
Sponsor	Department of Health
Funder	Sussex NHS Research Consortium (UK)

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 of protocol

Not provided at time of registration

Contact information

Miss Helena Read
Scientific

Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Phone	+44 (0)1903 285222 x 5698
Email	helena.read@wash.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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)
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	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
Completion date	08/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	140
Key inclusion criteria	1. 140 patients being treated for breast cancer and receiving chemotherapy. 2. 18 years and above
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	06/01/2005
Date of final enrolment	08/03/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Worthing & Southlands Hospitals NHS Trust

Worthing
BN11 2DH
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?
Results article	results	12/03/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes