Palliative Care Clinical Trial
— PiPCAROfficial title:
Participating in Palliative Care Research
NCT number | NCT04894162 |
Other study ID # | NHCT0230 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | June 30, 2022 |
Verified date | April 2022 |
Source | Northumbria Healthcare NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research seeks the views of patients who are admitted to hospices and specialist palliative care units (SPCUs) regarding whether they would consider being involved in different types of clinical research. This is a questionnaire based study of inpatients in the North East of England. The results will be used to inform healthcare professionals about the research which patients may or may not be interested in, as well as enabling future research design to be supportive of patient preferences. Many of the interventions used within specialist palliative care lack a strong evidence base with guidelines often based on a mixture of expert opinion, anecdotal evidence or extrapolated from research in other patient groups rather than robust clinical research. Previous studies have highlighted multiple potential barriers to expanding research within the palliative care setting. Barriers include a lack of funding compared to other medical specialties and a lack of institutional capacity. An ongoing barrier to research in this field is that the nature of the population makes patient recruitment to research challenging. This may be associated with professionals in palliative care being reluctant to ask patients if they would want to be involved in research as they feel that it would be inappropriate to potentially burden patients who are very unwell with research which is unlikely to change the disease outcome for the individual. However, many recognise that it is important to understand what patients themselves think about the potential to take part in clinical research. Our main research question will help us to ascertain whether patients admitted under Palliative Medicine in our region would welcome the opportunity to be involved in clinical research. Previous studies have been at a single site with small numbers of patients, whereas our research will aim to recruit a larger number of patients and will be a multi-centre study involving a range of inpatient settings including an independent hospice, two National Health Service (NHS) Palliative Care Units. These centres are across the north-east region (Northumbria and Newcastle) and accept admissions from a mixture of affluent and less affluent areas. It will also involve patients with both malignant and non-malignant disease. Previous studies have not surveyed patients that were described as "too unwell", therefore as a secondary outcome we will be recording how well patients are functionally (by recording performance status- AKPS) to examine if those patients who are most unwell would still want to be involved in research. There is a gap in current knowledge of whether those patients with advanced disease and close to end of life would still find it rewarding to have the opportunity to be involved in research of some sort and whether it is fair to exclude them from being offered opportunities to be involved based on their advanced disease status.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Inpatient on a specialist palliative care unit - Admitted in the study period. - Over 18 years of age - Willing to participate - Able to complete the questionnaire (with or without support) during their admission Exclusion Criteria: - Lack of capacity to consent to involvement in the study - Clinical team consider the offer of participation may cause distress or burden - Patients not under the care of the specialist palliative care team e.g. medical borders (this exclusion criteria is only relevant to the specialist palliative care units attached to hospitals and not the hospice) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Wansbeck General Hospital | Ashington | |
United Kingdom | St Oswald's Hospice | Newcastle | |
United Kingdom | North Tyneside General Hospital | North Shields |
Lead Sponsor | Collaborator |
---|---|
Northumbria Healthcare NHS Foundation Trust |
United Kingdom,
Chen EK, Riffin C, Reid MC, Adelman R, Warmington M, Mehta SS, Pillemer K. Why is high-quality research on palliative care so hard to do? Barriers to improved research from a survey of palliative care researchers. J Palliat Med. 2014 Jul;17(7):782-7. doi: 10.1089/jpm.2013.0589. Epub 2014 Jun 2. — View Citation
Downing A, Morris EJ, Corrigan N, Sebag-Montefiore D, Finan PJ, Thomas JD, Chapman M, Hamilton R, Campbell H, Cameron D, Kaplan R, Parmar M, Stephens R, Seymour M, Gregory W, Selby P. High hospital research participation and improved colorectal cancer survival outcomes: a population-based study. Gut. 2017 Jan;66(1):89-96. doi: 10.1136/gutjnl-2015-311308. Epub 2016 Oct 19. — View Citation
Henderson M, Addington-Hall JM, Hotopf M. The willingness of palliative care patients to participate in research. J Pain Symptom Manage. 2005 Feb;29(2):116-8. — View Citation
Higginson IJ. Research challenges in palliative and end of life care. BMJ Support Palliat Care. 2016 Mar;6(1):2-4. doi: 10.1136/bmjspcare-2015-001091. — View Citation
Lunder U, Sauter S, Fürst CJ. Evidence-based palliative care: beliefs and evidence for changing practice. Palliat Med. 2004 May;18(4):265-6. — View Citation
Ross C, Cornbleet M. Attitudes of patients and staff to research in a specialist palliative care unit. Palliat Med. 2003 Sep;17(6):491-7. — View Citation
Terry W, Olson LG, Ravenscroft P, Wilss L, Boulton-Lewis G. Hospice patients' views on research in palliative care. Intern Med J. 2006 Jul;36(7):406-13. — View Citation
White C, Hardy J. What do palliative care patients and their relatives think about research in palliative care?-a systematic review. Support Care Cancer. 2010 Aug;18(8):905-11. doi: 10.1007/s00520-009-0724-1. Epub 2009 Aug 25. Review. — View Citation
White CD, Hardy JR, Gilshenan KS, Charles MA, Pinkerton CR. Randomised controlled trials of palliative care - a survey of the views of advanced cancer patients and their relatives. Eur J Cancer. 2008 Sep;44(13):1820-8. doi: 10.1016/j.ejca.2008.05.003. Epub 2008 Jun 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients admitted consecutively to specialist palliative care inpatient units in the North east of England who wish to participate in research - binary Yes/No outcome. | Questionnaire study of consecutively admitted inpatients in specialist palliative care inpatient units. | 6 months | |
Secondary | Proportion of patients who express a desire to participate in research who have malignant (vs non-malignant) disease. | Details of diagnosis (malignant or non-malignant) will be gathered to determine whether there is a difference between those with cancer and those with non-malignant disease, in relation to their preferences for research participation. | 6 months | |
Secondary | Proportion of patients who express a desire to participate in research who have an Australia-modified Karnofsky Performance Scale (AKPS) of =70%, between 40% and 60% and =30% respectively. | Data regarding functional status (using the Australia-modified Karnofsky Performance Scale) will be gathered to determine whether there is a difference between those with higher or lower functional scores, in relation to their preferences for research participation. | 6 months | |
Secondary | Proportion of patients who express a desire to participate in research who survive =1 week, = 2weeks, =3 weeks, =4weeks, between 4-6 weeks, between 6-8 weeks, between 8-12 weeks, between 3-6 months and >6 months from completion of questionnaire. | Outcome data (regarding living at home, in care home, in hospital or death) will be gathered after 3 and 6 months following completion of the questionnaire, to determine whether there is a difference between those who have a shorter or longer prognosis, and their desire to participate in research. | 18 months from first patient recruitment |
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