Condition category
Cancer
Date applied
03/07/2017
Date assigned
05/07/2017
Last edited
16/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

http://research.hyms.ac.uk/researchcentres/chaps/seda/research-project/r

Contact information

Type

Public

Primary contact

Dr Joseph Clark

ORCID ID

Contact details

SEDA Research Group
Hertford Building
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34461

Study information

Scientific title

Cancer Needs Assessment in Primary Care: A cluster randomised feasibility trial (cRCT) to test the routine use of the NAT:PD-C in primary care to reduce unmet cancer patient and caregiver need and determine the feasibility of a definitive trial

Acronym

CANAssess:PC

Study hypothesis

The aim of this study is to investigate if a cluster randomised controlled trial (cRCT) to test the routine use of the Needs Assessment Tool Progressive Disease Cancer (NAT:PD-C) in primary care to reduce unmet patient and carer needs is feasible.

Ethics approval

Yorkshire & The Humber - Leeds East Research Ethics Committee, 23/05/2017, ref: 17/YH/0141

Study design

Randomised; Both; Design type: Process of Care, Complex Intervention, Management of Care, Qualitative

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Primary Care, Primary sub-specialty: Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of independent (primary) multiple sites

Intervention

Participants are asked to complete five study questionnaires about their health and wellbeing. Participants are asked to nominate a carer to join the study if they have one. Carers are requested to complete two study questionnaires on entry to the study about their experience of caring and wellbeing. They are then requested to arrange a 20 minute appointment at their GP practice as directed by the researcher. The researcher measures how many patient appointments are conducting using the NAT:PD-C.

The most appropriate way to recruit patients for a needs assessment appointment administered by a clinician trained in the use of the NAT:PD-C is done by randomly allocating participants to one of two groups. Randomisation (1:1) takes place at the cluster level to either:

1. Promotion and use of the NAT:PD-C with directed clinical encounter with NAT:PD-C trained clinician. Participating GP practices are trained on how to use the NAT:PD-C. The main aim of this arm is to evaluate if participants are happy to attend an appointment with NAT- trained clinician with whom they do not have an existing relationship with.

2. Promotion and use of the NAT:PD-C with clinical encounter a with a clinician in line with usual practice. The main issue is how many patients will not have a NAT-guided consultation, if as many clinicians are trained as possible, but are not directed towards a specific clinician and simply asked to make an appointment.

GPs and nurses on both arms of the trial are trained in the use of the NAT:PD-C. The uncertainty here relates to the best way of ensuring that patients have a NAT:PD-C-guided consultation, to inform the primary outcome of a potential future definitive trial. For example, we do not know if patients will find it acceptable to be directed towards a NAT:PD-C trained clinician if they have not seen that person before and have a pre-existing relationship with another clinician.

Patients (and carers) are then requested to complete the study questionnaires after one, three and six months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Recruitment is assessed by calculating the number of GP practices recruited, number of patients screened, eligible, contacted by usual care team, agreeing to researcher contact, and registered per practice, rate of patients (and caregivers) recruited across the feasibility sites over six months
2. Uptake and delivery is assessed by calculating the uptake of the NAT:PD-C, the expected number of completed NAT:PD-C forms completed per patient vs actual will be assessed, total patients by trial arm seen by a NAT:PD-C trained clinician and had a NAT:PD-C completed for that consultation, time from baseline to needs assessment appointment, length of appointments at six months
3. Data collection and quality: Participant reported questionnaire completion rates, amount/pattern of missing data and sub-scales of the proposed primary outcome measure the SCNS, patient/carer outcomes i.e. unmet needs, ability to care, quality of life, performance at six months

Secondary outcome measures

1. Patients’ supportive care needs are measured measured using the Supportive Care Needs Survey (SCNS-SF34) at baseline, one, three and six months.
2. Patients’ symptom burden is measured using the Edmonton Symptom Assessment System (ESAS-R) at baseline, one, three and six months
3. Patients’ health status is measured using EORTC QLQ-C15-PAL at baseline, one, three and six
4. Patients’ use of health care services and personal expenses is measured using Resource Use Questionnaire (RUQ) at one, three and six
5. Patients’ co-morbidities are measured using Charlson Co-morbidity Index (CCI) at baseline
6. Patients’ performance status is measured using Australian Modified Karnofsky Scale (AMKS) at baseline, one, three and six
7. Patients’ wellbeing is measured using ICECAP Supportive Care Measure (ICECAP-SCM) at baseline, one, three and six
8. Patients’ health status is measured using EQ-5D-5L at baseline, one, three and six
9. Carers’ support needs are measured using Carer Support Needs Assessment Tool (CSNAT) at baseline, one, three and six
10. Carers’ experience of caring is measured using the Carer Experience Scale (CES) at baseline, one, three and six
11. Patient/carer need is measured using the Needs Assessment Tool Progressive Disease Cancer (NAT:PD-C) post-baseline

Overall trial start date

01/09/2016

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Patient level:
1. Adults (aged 18 and above)
2. Diagnosis of active incurable cancer
3. Willing to have a consultation with a practice clinician
4. Able to complete study measures
5. Written or observed verbal informed consent

Carers:
1. Adults (aged 18 and above)
2. Nominated by the patient
3. Able to complete study measures
4. Written or observed verbal informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

Patient level:
1. Patients in complete remission
2. Patients receiving treatment with intent to cure (patients receiving anti-cancer treatments with the intention to palliate, OR receiving supportive care only will be eligible).
3. Patients living in a care home or other institutional setting
4. Patients who do not speak English well enough to provide informed consent and complete study measures.
5. Known to have a co-morbid condition which means they lack sufficient mental capacity to provide informed consent in the opinion of the clinician (e.g. dementia)
6. Have known of their diagnosis for less than one month

Carer level:
1. Carers who do not speak English well enough to provide informed consent and complete study measures.
2. Paid carers

Recruitment start date

15/07/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

James Alexander Family Practice
HU7 4DW
United Kingdom

Trial participating centre

Hedon Group Practice
HU12 8JD
United Kingdom

Sponsor information

Organisation

University of Hull

Sponsor details

Research and Enterprise
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom
+44 1482463123
andrew.taylor@hull.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Yorkshire Cancer Research

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of the results in high quality medical journals relevant to: palliative care, cancer and primary care.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/07/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/10/2017: Internal review. 11/08/2017: Internal review.