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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03243188
Other study ID # IRAS ID 225027
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 27, 2017
Last updated August 3, 2017
Start date October 2017
Est. completion date December 2018

Study information

Verified date July 2017
Source King's College London
Contact Emilie Green
Phone 02078488679
Email emilie.green@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study Title: Palliative care in general practice: cancer patients' and carers' experience of their GP's role

Study Design: Qualitative interview study

Study Participants: Adult patients with cancer and palliative care needs, accompanied by their carers

Planned Sample Size: Up to 30 interviews with patients +/- their carers

Planned Study Period: October 2017 - December 2018

Research Question: What experience do adults with cancer, and carers, have of their GP's involvement in palliative care provision?


Description:

Participants will be invited and recruited to the study from St Joseph's Hospice in Hackney (single centre study). Patients with cancer that are either attending the day centre service at St Joseph's or being visited at home by the community specialist palliative care nursing/medical team based at St Joseph's Hospice; will be approached by their direct clinical care staff. (Some of the direct clinical care team are National Health Service (NHS) staff and some care is commissioned by the NHS despite St Joseph's Hospice being a non-NHS site). Staff will initiate discussion about the project, and will assess for both mental and physical capacity to participate.

Dr Emilie Green (EG) will then contact the potential participants by phone or in person (if they have previously given verbal consent for her to join their usual clinical staff on a home visit or when they are attending the day centre). The project will be discussed with each potential participant, and EG will answer any questions they may have, will assess for mental and physical capacity, and will arrange a mutually convenient time and location to meet for the interview.

Before starting the interview, EG will again make time to clarify any questions each participant may have. She will ask each participant to date/sign three consent forms before starting the interview (one for EG, one for the participant, and one for their notes at St Joseph's Hospice). If a joint interview is undertaken with a patient and their carer; both parties will individually sign their own consent forms. She will then ask questions relating to sociodemographic data (recording this on the Personal Information Sheet) e.g. age, living situation and diagnosis before starting the interview. The interviews will each last at least 30 minutes.

If participants decide that they would like a telephone interview, the process will be slightly different. EG will send three consent forms to each prospective participant (one for them to keep, and two for them to date/sign and send back by post) in a stamped addressed envelope. If the forms are not received within 3 weeks, EG will follow up with a phone call to the prospective participant, to clarify whether they still wish to participate. Only after she receives the two dated/signed consent forms will EG arrange a time with them for the telephone interview. She will then phone the participant from a private location that she does not share with other colleagues. She will collect sociodemographic information (which will be recorded on the Personal Information Sheet) before starting the interview (which will last at least 30 minutes.)

Qualitative data will be obtained through semi-structured interviews with adults with cancer and palliative care needs. Patients will be invited to bring their carer to the interview. EG will conduct and transcribe up to 30 audio-recorded semi-structured interviews, which will be carried out at the patient's preferred location (either at home, over the phone, or in a pre-booked room at St Joseph's Hospice). EG will ask questions relating to sociodemographic data (recording this on the Personal Information Sheet) prior to starting the interview.

EG will transcribe all interviews verbatim. Data will be analysed thematically and will adhere to the principles of the Framework Analysis developed by Ritchie and Spencer. Recurring themes and concepts will be identified using a constant comparative approach. Any contributions made by carers will be included and analysed as 'added value' data.This will enable us to explore if and how carers' perspectives contribute to our understanding of patient experience of their GP's involvement in palliative care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria for participants

- Patients either attending the St Joseph's Hospice day centre or being visited at home by their community specialist palliative care nursing/medical team and their carers

- Adult patients with a cancer diagnosis and their carers

- Able to understand and communicate in written and spoken English

- With mental and physical capacity to consent Exclusion criteria for participants

- Paediatric patients

- Patients without a cancer diagnosis

- Unable to understand written or spoken English

- Without mental and physical capacity to consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Qualitative interview
Qualitative data will be obtained through semi-structured interviews with adults with cancer and palliative care needs. Patients will be invited to bring their carer to the interview. EG will conduct and transcribe up to 30 audio-recorded semi-structured interviews, which will be carried out at the patient's preferred location (either at home, over the phone, or in a pre-booked room at St Joseph's Hospice). EG will ask questions relating to sociodemographic data (recording this on the Personal Information Sheet) prior to starting the interview.

Locations

Country Name City State
United Kingdom King's College London London

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To explore the experience/perspectives of adults with cancer, and carers, of the role of their GP in providing palliative care, using a qualitative semi-structured interview schedule To explore patients' and carers' experience of:
The role of the GP in providing palliative care to adult patients with cancer
The facilitators and barriers to the GP's capacity to fulfill this perceived role
October 2017 - December 2018
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