Cancer needs assessment in primary care

ISRCTN	ISRCTN22325477
DOI	https://doi.org/10.1186/ISRCTN22325477
IRAS number	221366
Secondary identifying numbers	34461, IRAS 221366

Submission date: 03/07/2017
Registration date: 05/07/2017
Last edited: 05/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-new-way-to-assess-the-needs-of-people-with-cancer

Study website

Contact information

Dr Joseph Clark
Public

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

Study information

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
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	See additional files
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
Study 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(s)	Yorkshire & The Humber - Leeds East Research Ethics Committee, 23/05/2017, ref: 17/YH/0141
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
Primary outcome measure	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 study start date	01/09/2016
Overall study end date	30/11/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 60; UK Sample Size: 60
Total final enrolment	64
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 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	31/03/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

James Alexander Family Practice

Hull
HU7 4DW
United Kingdom

Hedon Group Practice

Hull
HU12 8JD
United Kingdom

Sponsor information

University of Hull
Hospital/treatment centre

Research and Enterprise
University of Hull
Cottingham Road
Hull
HU6 7RX
England
United Kingdom

Phone	+44 1482463123
Email	andrew.taylor@hull.ac.uk
"ROR"	https://ror.org/04nkhwh30

Funders

Funder type

Charity

Yorkshire Cancer Research
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date	01/07/2018
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	Planned publication of the results in high quality medical journals relevant to: palliative care, cancer and primary care.
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	28/01/2021	29/03/2021	Yes	No
HRA research summary		28/06/2023	No	No
Protocol file	09/05/2017	05/09/2023	No	No

Additional files

ISRCTN22325477_Protocol_09May2017.pdf

Editorial Notes

05/09/2023: The following changes have been made:
1. Uploaded protocol (not peer reviewed).
2. IRAS number added.
29/03/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
22/01/2018: The recruitment end date was changed from 31/12/17 to 31/03/18
16/01/2018: Cancer Help UK lay summary link added to plain English summary field
16/10/2017: Internal review.
11/08/2017: Internal review.