Condition category
Cancer
Date applied
21/01/2015
Date assigned
21/01/2015
Last edited
14/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Zoe Edwards

ORCID ID

http://orcid.org/0000-0001-6525-8190

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

The plan is 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 a community pharmacy based service will be designed and implemented to help patients with cancer pain.

Ethics approval

Leeds West REC, 15/10/2014, ref: 14/YH1126

Study design

Non-randomised; Interventional and Observational

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Cancer

Intervention

Current interventions as of 14/12/2016:
Stage 1
Patients with pain from advanced cancer will be interviewed to find out how they use their community pharmacy. They will discuss continuity of use, what experiences they have of community pharmacy services, and what would be helpful to them from a community pharmacy service. The trialists will also explore how services can be provided for patients with pain from cancer.

Stage 2
A multi-stakeholder workshop will be held inviting pharmacists, doctors, nurses, policy makers and educators as well as academics. They will explore what needs and barriers exist for the provision of a community pharmacy based medicine optimisation service for patients suffering from cancer pain. Baseline questionnaires will also be completed with healthcare professionals about community pharmacy services for patients with cancer pain.

Stage 3
The design of the service will be finalised and patients recruited. After baseline questionnaires, a medicine optimisation service will be provided for patients with cancer pain to help them get the most benefit from the medicines they are taking. Post-consultation questionnaires will be completed with the patients, pharmacists and healthcare professionals involved.

Previous interventions:
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

Current primary outcome measures as of 14/12/2016:
The acceptability of the pain medicines consultation to patients, assessed by postal questionnaire two weeks after their final consultation

Previous primary outcome measures:
Feasibility of the process; Timepoint(s): by the end of the study

Secondary outcome measures

Added 14/12/2016:
The feasibility of delivering the pain medicines consultation to patients with advanced cancer, assessed by how many patients are recruited and whether the consultations can be delivered to them

Overall trial start date

30/12/2014

Overall trial end date

14/04/2017

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

31/03/2017

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

To be confirmed at a later date

IPD sharing plan
Data will be held at Bradford University on password-controlled computers and then archived at Leeds University. Patient level data will not be available unless there is no risk of identifying patients involved.

Intention to publish date

14/04/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/12/2016: The overall trial end date was changed from 02/09/2015 to 14/04/2017.