Condition category
Cancer
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
10/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Helena Read

ORCID ID

Contact details

Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
+44 (0)1903 285222 x 5698
helena.read@wash.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0283156787

Study information

Scientific title

Acronym

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

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)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

Randomisation into a research or control arm:
Group A: attend pharmacy outpatient clinic
Group B: usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

06/01/2005

Overall trial end date

08/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. 140 patients being treated for breast cancer and receiving chemotherapy.
2. 18 years and above

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

140

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

06/01/2005

Recruitment end date

08/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Sussex NHS Research Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17311014

Publication citations

  1. Results

    Read H, Ladds S, Rhodes B, Brown D, Portlock J, The impact of a supplementary medication review and counselling service within the oncology outpatient setting., Br. J. Cancer, 2007, 96, 5, 744-751, doi: 10.1038/sj.bjc.6603634.

Additional files

Editorial Notes