Medicines optimisation in cancer pain

ISRCTN	ISRCTN14670659
DOI	https://doi.org/10.1186/ISRCTN14670659
Protocol serial number	17969
Sponsor	University of Bradford
Funder	National Institute for Health Research

Submission date: 21/01/2015
Registration date: 21/01/2015
Last edited: 12/09/2022

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

http://www.cancerresearchuk.org/about-cancer/trials/a-study-looking-at-improving-cancer-pain-managed-in-the-community-impacct

Contact information

Mrs Zoe Edwards
Scientific

University of Bradford
Richmond Road
Bradford
BD7 1DP
United Kingdom

ORCID ID	0000-0001-6525-8190

Study information

Primary study design	Interventional
Study design	Non-randomised; Interventional and Observational
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	IMPACCT: exploratory study of a community pharmacy pain medicines consultation for patients with cancer pain
Study objectives	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(s)	Leeds West REC, 15/10/2014, ref: 14/YH1126
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	14/04/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	45
Key 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
Key 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.
Date of first enrolment	30/12/2014
Date of final enrolment	31/03/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Bradford

Richmond Road
Bradford
BD7 1DP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	medicines optimisation results	01/06/2019	24/06/2019	Yes	No
Results article	patient interview results	01/07/2018	24/06/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results		08/09/2022	12/09/2022	No	Yes

Editorial Notes

12/09/2022: A link to results in plain English has been added.
24/06/2019: Publication reference added.
16/10/2018: The publication and dissemination plan was updated.
14/12/2016: The overall trial end date was changed from 02/09/2015 to 14/04/2017.