Condition category
Cancer
Date applied
21/01/2015
Date assigned
21/01/2015
Last edited
05/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Zoe Edwards

ORCID ID

Contact details

University of Bradford
Richmond Road
Bradford
BD7 1DP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17969

Study information

Scientific title

IMPACCT: exploratory study of a community pharmacy pain medicines consultation for patients with cancer pain

Acronym

Study hypothesis

We plan to interview patients suffering from cancer pain in order to gain insights into their needs in relation to pharmacies and medicines. With this information and a workshop with healthcare practitioners we will design and implement a community pharmacy based service to help patients with cancer pain.

Ethics approval

158740

Study design

Non-randomised; Interventional and Observational

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Cancer

Intervention

Medicines Use Review (MUR) type intervention in a community pharmacy specifically for patients with cancer pain.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility of the process; Timepoint(s): by the end of the study

Secondary outcome measures

N/A

Overall trial start date

30/12/2014

Overall trial end date

02/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Stage 1
1. Aged 16 or over
2. Have advanced cancer and pain
3. Been receiving strong opiods for 2 weeks or more (morphine, fentanyl, buprenorphine, diamorphine, hydromorphone, methadone or oxycodone)
4. Have a good level of spoken and written English (we do not have the resources to employ an interpreter at this time)
5. Have the capacity to provide informed consent to participate
6. Be deemed well enough to take part by their healthcare provider

Stage 3 - as well as the criteria for stage 1 the participants should
1. Regularly use the pharmacies participating in the study it is not feasible to train all the local pharmacists to provide this service at this point but may be an option for future role out.

Patients with advanced cancer will be defined as:
Those with metastatic cancer (histological, cytological or radiological evidence) AND/OR those receiving anti-cancer therapy with palliative intent

Patients with pain will be defined as:
Those receiving strong opiod analgesic treatment for cancer symptom-related pain AND/OR those receiving analgesics for treatment of cancer therapy-related pain

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 45; UK Sample Size: 45

Participant exclusion criteria

Stage 1 and 3
1. Are unconscious or confused
2. Are, in the opinion of the clinician, unable to understand and complete the interview or questionnaires (due to cognitive impairment for example)
3. Are unwilling to provide informed consent
4. We are not looking to recruit patients in the last days of life so we will exclude those who have received anticipatory medicines in readiness for this

Stage 3 only
1. They do not use one of the participating pharmacies (although these patients may be included at a later date if the study is expanded)
2. Patients who are deemed ethically inappropriate to approach for example where death is imminent.

Recruitment start date

30/12/2014

Recruitment end date

02/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bradford
Richmond Road
Bradford
BD7 1DP
United Kingdom

Sponsor information

Organisation

University of Bradford

Sponsor details

Richmond Road
Bradford
BD7 1DP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

14/01/2016: Internal corrections.