Palliative Care in General Practice: Cancer Patient/Carer Experience

August 3, 2017 updated by: King's College London

Palliative Care in General Practice: Cancer Patients' and Carers' Experience of Their General Practitioner's (GP's) Role

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 1UL
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be invited and recruited to the study from St Joseph's Hospice in Hackney (single centre study). Patients and their carers from all three geographical areas, served by St Joseph's, will be invited to participate: City & Hackney, Tower Hamlets and Newham. The Principal Investigator Jane Naismith (JN) working at St Joseph's Hospice will assist with and coordinate the recruitment process.

This setting was chosen as it permits access to a varied group of patients and carers. A purposive sampling will ensure recruitment of patients across a breadth of socio-demographics, cancer diagnoses and experience of different GP practices.

A target sample size of up to 30 interviews has been chosen, taking into account available time and resources.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants
Cancer patients with palliative care needs (+/- their carers)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: October 2017 - December 2018

To explore patients' and carers' experience of:

  1. The role of the GP in providing palliative care to adult patients with cancer
  2. The facilitators and barriers to the GP's capacity to fulfill this perceived role
October 2017 - December 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jane Naismith, St Joseph's Hospice
  • Study Director: Patrick White, King's College London
  • Study Director: Heidi Lempp, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS ID 225027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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