Plain English Summary
Mrs Zoe Edwards
University of Bradford
IMPACCT: exploratory study of a community pharmacy pain medicines consultation for patients with cancer pain
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.
Leeds West REC, 15/10/2014, ref: 14/YH1126
Non-randomised; Interventional and Observational
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Current interventions as of 14/12/2016:
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.
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.
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.
Medicines Use Review (MUR) type intervention in a community pharmacy specifically for patients with cancer pain.
Primary outcome measure
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
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
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
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
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
Recruitment end date
Countries of recruitment
Trial participating centre
University of Bradford
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The study has been submitted to a journal and it is envisaged that it will be accepted by the end of 2018.
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
Participant level data
Stored in repository
Basic results (scientific)
1. 2018 patient interview results in https://www.ncbi.nlm.nih.gov/pubmed/29479766 (added 24/06/2019)
2. 2019 medicines optimisation results in https://www.ncbi.nlm.nih.gov/pubmed/30963448 (added 24/06/2019)