Barriers and facilitators to deprescribing antithrombotic therapy in advanced cancer patients: A qualitative interview study of patients’, companions’ and clinicians’ experiences and perspectives
| ISRCTN | ISRCTN18388825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18388825 |
| IRAS number | 323195 |
| Secondary identifying numbers | 10039823, IRAS 323195 |
- Submission date
- 30/01/2023
- Registration date
- 08/02/2023
- Last edited
- 16/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
For some patients with cancer, medicine given to thin the blood (known as antithrombotic therapy) can have some negative effects (such as excessive bleeding) and this can have an effect on their quality of life and well-being. Doctors might suggest that stopping this medicine could be helpful for some patients if they became further unwell with cancer, but what patients think about this is important. In addition, patients and their families/loved ones will need information and support to help them understand the risks and benefits of both continuing or stopping this medicine. However, firstly, we need to understand what the views and experiences of patients are around this subject, as well as that of their clinicians, as their current views and experiences are unknown. The results of these interviews will lead to the next stage of a larger study, which will be the development of an app. This app will contain information and support to help future cancer patients make choices about continuing or stopping this medicine in partnership with their doctors (known as shared-decision making).
Who can participate?
Patients who have cancer and are currently taking medicine to thin their blood (known as antithrombotic therapy) either due to a heart condition or they have developed a blood clot as a result of their cancer. Patients may include a companion to take part with them should they wish to do so. Clinicians will also be interviewed, from a variety of specialities involved in the management of these patients.
What does the study involve?
A 30-60 minute interview to explore experiences, values and perspectives on antithrombotic therapy at the end of life.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part, however, views and experiences will be used to inform the development of a shared decision-making app to help future patients make joint decisions about continuing or not continuing their antithrombotic medicine near the end of life. There are no anticipated risks to participating, participants will take part in one 30-60 minute interview. Topics discussed may result in some distress, however, this will be managed by experienced qualitative researchers. Taking part does not have any influence or impact on their existing care/treatment.
Where is the study run from?
This study is being carried out across Europe (UK, Denmark, Spain and France) to get the perspectives of patients with cancer and clinicians from these countries. Each research institution is responsible for carrying out the research separately and has its own research approvals in place.
When is the study starting and how long is it expected to run for?
September 2022 to October 2024
Who is funding the study?
INNOVATE UK/Horizon Europe
Who is the main contact?
Prof Simon Noble (Chief Investigator), NobleSI1@cardiff.ac.uk (UK)
Contact information
Principal Investigator
3rd Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
 ORCID ID |
0000-0001-5425-2383 |
|---|---|
| Phone | +44 (0)2920687500 |
| NobleSI1@cardiff.ac.uk |
Scientific
Department of Cardiology
Aalborg University Hospital
Niels Jernes Vej 10
Aalborg
9220
Denmark
| ORCID ID |
0000-0002-3851-3069 |
|---|---|
| Phone | None provided |
| a.wind@rn.dk |
Public
8th floor
Neuadd Meirionnydd
University Hospital of Wales
Heath Park
Cardiff
CF14 4YS
United Kingdom
| ORCID ID |
0000-0002-6075-8425 |
|---|---|
| Phone | +44 (0)29 2068 7473 |
| NelsonA9@cardiff.ac.uk |
Study information
| Study design | Qualitative interview study |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | GP practice, Home, Hospice, Hospital, Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Barriers and facilitators to deprescribing antithrombotic therapy in advanced cancer patients: A qualitative interview study of patients’, companions’ and clinicians’ experiences and perspectives |
| Study acronym | SERENITY |
| Study hypothesis | The aim of this qualitative study is to explore what influences the current practice of continuing and deprescribing antithrombotic therapy in cancer patients and identify potential barriers and facilitators to changing antithrombotic therapy at the end of life from the perspective of patients and clinicians. |
| Ethics approval(s) |
1. Approved 24/02/2023, London South East Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 2071048120; approvals@hra.nhs.uk), ref: 23/PR/0115 2. Approved 28/10/2022, The study is part of North Denmark Region’s record of processing activities (ID No. F2022-157). Other approvals are not necessary according to Danish legislation (Forskning, Uddannelse og Innovation, Forskningsdata og Statistik, Sdr. Skovvej 15, Aalborg, 9000, Denmark; -; forskningsanmeldelse@rn.dk), ref: F2022-157 3. Approved 29/05/2023, Comite de Etica de la Investigacion con medicamentos del Hospital Clinic de Barcelona (Hospital Clinic De Barcelona, Villarroel, Barcelona, 170-08036, Spain; -; cfont@clinic.cat), ref: HCB/2023/0336 4. Approved 28/04/2023, Comité de protection des personnes Ile de France I (Hopital Hotel Dieu - 1, place du Parvis Notre dame, Paris, 75004, France; +33 142348052; cppidf1.htd@aphp.fr), ref: CPPIDFI-2023-DI24-Cat3 |
| Condition | Cancer and deprescribing antithrombotic therapy at end-of-life |
| Intervention | Intervention A qualitative study design to gain insight and a deeper understanding of patients’ and clinicians’ experiences and perceptions of continuing and deprescribing antithrombotic therapy. This will be explored using semi-structured interviews with patients and clinicians, at one time point, using a semi-structured interview guide, and will last between 30-60 minutes. The interviews will be analysed using framework analysis. The decision whether to continue or to deprescribe antithrombotic therapy in patients with cancer at the end of life is not clear since both options bring with them competing risks and advantages. Key factors in decision-making include the views of patients, their companions, if present, and clinicians. Currently, experiences and perspectives informing their stance are unknown. This interview study aims to gain insight from patients and clinicians on this topic. The results (anonymous) will inform future stages of a larger programme of work. Patient participants will be identified by their lead consultant and approached by them during a routine clinical appointment and provided with a participant information sheet. Patient participants will be given a minimum of 24 hours to consider the information and are invited to have a companion take part with them. If the patient is interested, they can let their consultant know, or directly contact the researchers. An interview will be arranged at a time and mode of their choosing (face-to-face or remote). This may be at their home, at a hospital site or over telephone/remote video software (e.g. Zoom). A minimum of 15 patients will be recruited per participating country. In the event of participant distress due to discussion of sensitive topics, or if a clinical issue emerges, the researchers, using their experience, will react at the time and will refer the issue to the participants’ clinical team, with their permission. Clinician participants will be sampled from different specialities and will be identified as eligible and recruited through hospital management or hospital directories and invited by email to participate, with the participant information sheet. A total of 18-24 clinicians per participating country will be recruited, from the following specialities: Oncology, Care of the Elderly (Geriatrics), Frailty, Stroke Medicine, Palliative/Hospice Care, General Practitioner, Cardiology, Respiratory Medicine, and Vascular surgery. Interviews will be undertaken at participants' preferred location – face-to-face at a hospital site, or remotely, over video software or telephone. Informed consent will be obtained from all participants prior to the interview, and participants will be made clear they can withdraw at any point. The researcher will take consent and conduct the interview. All interviews will be audio recorded; the recordings will be stored securely in locked files held within university servers, with restricted access. Audio files of the interviews will be transcribed verbatim by a member of the research team or a trusted, approved transcription agency. Transcripts will be anonymised prior to data analysis. Consent forms will also be stored securely, separate from anonymised transcripts. The participant information sheet contains detailed information on the confidentiality and data protection of data obtained during the interview, including how it will be stored, and how their anonymised data will be used/disseminated. The protocol will have the favourable opinion of a Research Ethics committee, as well as R&D approval from the recruiting sites prior to any research activity. The interview transcripts (which will have been anonymised before analysis) will be analysed using framework analysis. Framework analysis was developed for use in applied policy research where objectives are clearly set and shaped by specific outcome needs with the intention of developing actionable outcomes and providing answers. NVivo 12 will be used as a data management tool to assist the analytical process. The themes and sub-themes identified will be displayed/summarised in a framework. |
| Intervention type | Other |
| Primary outcome measure | Outcome variables are measured using a 30-60 minute interview at one time point: 1. Cancer patients’ (and companions’ if present) experiences, values, and perspectives on antithrombotic therapy measured using a semi-structured interview guide 2. Clinicians’ experiences of the current practice of continuing and deprescribing antithrombotic therapy to cancer patients, and their perceptions of key facilitators and barriers to deprescribing measured using a semi-structured interview guide |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2022 |
| Overall study end date | 01/10/2024 |
Eligibility
| Participant type(s) | Patient, Health professional, Carer, Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Minimum of 15 patients (and companions if present), and 18-24 clinicians, per research institution |
| Participant inclusion criteria | Patients: 1. Aged 18 years old and over 2. Advanced cancer (whose life expectancy is less than one year, according to the healthcare professional identifying eligible participants) 3. Receiving antithrombotic medicine for one of the following diseases: atrial fibrillation/stroke prevention, mechanical heart valve, peripheral vascular disease, and deep vein thrombosis or pulmonary embolus 4. Capacity to give informed consent 5. Capacity to undertake an interview in English Companions: 1. Companions are defined as person(s) who look after and/or support the patient as identified and chosen by the patient to take part alongside them, should the companion wish to do so 2. Aged 18 years old and over 3. Capacity to give informed consent 4. Capacity to undertake an interview in English Clinicians: Clinicians practising in their chosen speciality for 10 years or more, from across the following specialities: oncology, care of the elderly, frailty, stroke medicine, palliative/hospice care, family physician/general practice, cardiology, respiratory medicine, and vascular surgery |
| Participant exclusion criteria | Patients and companions: 1. Cognitive impairment 2. Unable to speak or understand English 3. Considered too unwell to participate in a 30-60 minute interview |
| Recruitment start date | 01/04/2023 |
| Recruitment end date | 31/07/2024 |
Locations
Countries of recruitment
- Denmark
- France
- Spain
- United Kingdom
- Wales
Study participating centres
St Cadoc's Hospital
Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
Cardiff
CF14 2TL
United Kingdom
Hobrovej
Aalborg
18-22, 9000
Denmark
Aalborg
18-22, 9000
Denmark
Institut Clinic de Malalties Hematològiques i Oncològiques (ICMHO)
Institut per a la Recerca Biomèdica August Pi i Suñer (IDIBAPS)
Villarroel street 170
Barcelona
08036
Spain
Paris
75004
France
Sponsor information
University/education
Cardiff Joint Research Office
Lakeside Building 2nd Floor
Heath Park
Cardiff
CF14 4YS
Wales
United Kingdom
| Phone | +44 (02)920879273 |
|---|---|
| resgov@cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Hospital/treatment centre
Department of Cardiology
Centre for Thrombosis and Drug Research
Hobrovej
Aalborg
18-22, 9000
Denmark
| Phone | +4597664442 |
|---|---|
| trombose@rn.dk | |
| Website | http://www.aalborguh.rn.dk/ |
|
"ROR" |
https://ror.org/02jk5qe80 |
Hospital/treatment centre
Medical Oncology Department
Institut Clinic de Malalties Hematològiques i Oncològiques (ICMHO)
Institut per a la Recerca Biomèdica August Pi i Suñer (IDIBAPS)
Villarroel street 170
Barcelona
08036
Spain
| Phone | +34 93 227 5743 |
|---|---|
| CFONT@clinic.cat | |
| Website | https://www.clinicbarcelona.org/ |
|
"ROR" |
https://ror.org/02a2kzf50 |
Hospital/treatment centre
3 Victoria Avenue
Paris
75004
France
| Phone | +33 1 40 27 50 05 |
|---|---|
| isabelle.mahe@aphp.fr | |
| Website | http://www.aphp.fr/ |
|
"ROR" |
https://ror.org/00pg5jh14 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- innovateuk
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Planned publication in a high-impact and peer-reviewed journal 2. Presentation at relevant research conferences 3. The data will be used to inform the development of a shared decision-making tool which forms part of the SERENITY project. Anonymised quotes will inform the subsequent project work packages. This will include a report of the Framework Analysis undertaken, in which themes from the data will be summarised and short, anonymised quotes will be used for the purpose of illustrating those summaries. 4. Selected quotes will be used to illustrate relevant topics and may be used to contribute to a wider body of work alongside similar data from Denmark, France, Spain, and Wales. 5. The data will be used for educational purposes |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
16/10/2024: The intention to publish date was changed from 30/09/2024 to 31/03/2025.
15/05/2024: The recruitment end date was changed from 31/03/2024 to 31/07/2024.
20/09/2023: A link to the HRA research summary was added.
22/06/2023: The following changes were made to the trial record:
1. The ethics approval was added.
2. The study settings GP Practice and Hospice were added.
3. The study website was added.
4. The participant types Patient, Health professional, and Carer were added.
03/02/2023: Trial's existence confirmed by Innovate UK.
