Condition category
Cancer
Date applied
09/03/2020
Date assigned
07/04/2020
Last edited
07/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Many people with cancer experience a wide range of symptoms and problems across all areas of life. Studies suggest that these symptoms are common but are often not known about or managed by the doctors and nurses caring for them.

The Needs Assessment Tool-Cancer (NAT-C) has been developed for use by doctors or other clinicians in GP Surgeries to identify and address any concerning symptoms and unmet needs of their cancer patients. We will test whether regular use of this tool improves patient care.

Who can participate?
Adults with cancer registered at a GP Surgery taking part in the trial. Surgeries will identify suitable participants through medical records and send a letter inviting them to take part. In this letter, we invite patients to nominate a relative/friend who cares for them to also take part.
Clinicians at intervention Surgeries and key stakeholders can take part in the sub-study (process evaluation).

What does the study involve?
Researchers will visit participants in their home or at their GP Surgery and ask them to complete a questionnaire about their level of need (patient) or caring situation (carer). All participants will be asked to complete the same questionnaire one month and three months later, and some will also be asked six months later. All participants are offered support by a researcher in completing these.
In this study, half of the GP Surgeries taking part will use a needs assessment tool (NAT-C). If patients are registered at one of these Surgeries, they will be asked to attend a NAT-C guided appointment.
In the sub-study, clinicians and key stakeholders will be asked to participate in surveys and interviews about their opinions and experiences of using the NAT-C needs assessment tool (intervention).

What are the possible benefits and risks of participating?
This study could improve the quality of life of people with cancer, but the researchers cannot say that they will definitely experience an improvement. If a patient’s GP Surgery is in in the intervention group, they may benefit from having a guided appointment.
There are no known risks of participating in this study. Participants agreeing to complete questionnaires will be giving up some of their time to do this.

Where is the study run from?
54 GP Surgeries across Yorkshire and Tyne and Wear.

When is the study starting and how long is it expected to run for?
March 2020 to August 2022

Who is funding the study?
Yorkshire Cancer Research (UK)

Who is the main contact?
Ms Emma McNaught (public), CANASSESS@leeds.ac.uk
Prof. Miriam Johnson (scientific), miriam.johnson@hyms.ac.uk


Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

Prof Miriam Johnson

ORCID ID

http://orcid.org/0000-0001-6204-9158

Contact details

Wolfson Palliative Care Centre
University of Hull
Hull
HU6 7RX
United Kingdom
+44 (0)1482 463442
miriam.johnson@hyms.ac.uk

Type

Public

Additional contact

Ms Emma McNaught

ORCID ID

Contact details

Clinical Trials Research Unit
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)113 3431978
CANASSESS@leeds.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 44992, IRAS 270012

Study information

Scientific title

CANAssess 2: Cancer Patients' Needs Assessment in Primary Care – A Cluster Randomised Controlled Trial

Acronym

CANAssess 2

Study hypothesis

The Needs Assessment Tool-Cancer (NAT-C) used by clinicians in Surgeries with their cancer patients will address patient unmet need resulting in a better quality of life, compared to usual care

Ethics approval

Approval pending, London - Surrey Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 1048129; nrescommittee.secoast-surrey@nhs.net), ref: 20/LO/0312

Study design

Complex intervention cluster randomized controlled trial including sub-study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neoplasms of uncertain or unknown behaviour

Intervention

The CANAssess study is a cluster-randomised controlled trial, where the whole GP Surgery (cluster) will be randomised to receive either the intervention or usual care. GP Surgeries will deliver either the intervention or usual care, according to their randomisation, to all patients they recruit onto the trial. The researchers cannot accurately predict what happens as part of usual care to be able to determine the effects of the intervention, which is why the researchers have a control group to also evaluate.

The researchers aim to recruit 1080 adult patients diagnosed with active cancer more than one month ago, and their friends/relatives who provide them with support. Eligible patients at 54 GP Surgeries will be sent an invitation letter introducing them to the study, with the Participant Information Sheet, the Carer Information Sheet, and a reply form enclosed. Patients are encouraged to return the reply form, using the pre-paid envelope provided, indicating whether they would like to take part or not. Patients who are willing to take part will then be contacted by a researcher to arrange a visit at the patient’s home or at the Surgery.

Eligible patients can also be approached about the study by their GP/nurse in clinic. Their GP/nurse will ask the patient if a researcher can contact them with further information about the trial. If they agree, they will be given the Participant Information Sheet and Carer Information Sheet to read, and a researcher will contact them to discuss and arrange a visit, if happy to do so.

At the visit, the researcher will screen the patient/patient and their carer to confirm they are eligible to take part. If eligible, the researcher will gain written informed consent and collect general demographics from the patient/patient and their carer. Consent is to data collection only. Patient consent includes access of their data through medical records. Patients will be asked to complete a questionnaire about their level of need, and carers will be asked to complete a questionnaire about their caring situation. Cancer demographics and co-morbidities will also be collected for the patient via medical records.

Patients registered at GP Surgeries allocated to the intervention will be invited to attend an appointment with their GP/nurse. The NAT-C needs assessment tool, the intervention, will guide this appointment with the patient. This will last approximately 20 minutes and can take place at the Surgery or at the patient’s home. Patients registered at GP Surgeries allocated to usual care will receive care as normal and will not be asked to attend the appointment.

All participants, patients and carers, will be asked to complete the same questionnaire completed at the visit at 1 month and 3 months post-registration. Some participants will also be asked to complete the questionnaire again at 6 months post-registration. This is so the researchers can determine any changes over the 6 month period. Each time a patient receives a questionnaire, a researcher will phone them to ask a few further questions about their physical ability. All participants will be given the opportunity for support by a researcher in the completion of questionnaires, either face-to-face or over the phone.

A sub-study will take place alongside the main study to determine clinician and key stakeholders’ views of using the intervention in GP Surgeries. Clinicians at GP Surgeries randomised to the intervention will be asked to complete two surveys, one at the intervention training session and one at the end of the trial. Completion of the survey will be understood as implied consent. At the end of the training session, clinicians will be asked for permission to be contacted to participate in interviews. Informed consent will be taken prior to interview. Key stakeholders will be approached by letter to take part in the surveys and interviews, and informed consent will also be taken prior to interview. A sample of 15-20 clinicians and 15-20 key stakeholders will be interviewed. Should the trial be positive, a plan will be developed for implementing the intervention in GP Surgeries across the UK.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Unmet need identified in any domain in the Supportive Care Needs Survey Short Form 34 (SCNS-SF34) at 3 months post-registration

Secondary outcome measures

Assessed at 1, 3 and 6 months post-registration, except for intervention uptake which is assessed at 3 months.
Effectiveness of the NAT-C compared to usual care with regard to:
1. The individual components of the primary endpoint, namely the proportion of patients with unmet need, and level of unmet need, on psychological, health system information, physical and daily activity, patient care and support, and sexuality domains, and overall on the SCNS-SF34 at 1, 3 and 6 months
2. Patient performance status, measured using the Australian-modified Karnofsky Performance Status (AKPS)
3. Patient severity of symptoms, measured using the Edmonton Symptom Assessment System (ESAS-r)
4. Patient mood and quality of life as measured by the EORTC QLQ-C15-PAL
5. Service utilisation and cost-effectiveness assessed using a bespoke Resource Use Questionnaire, the EQ-5D-5L and ICECAP-SCM
6. Caregivers’ ability to care and caregiver wellbeing as measured using the Carer Experience Survey (CES) and Zarit Burden Interview (ZBI-12).
7. Evaluate intervention delivery, uptake and fidelity of the NAT-C as measured by:
7.1. NAT-C training of GPs and nurses in each GP Surgery
7.2. Completed NAT-C consultations by patient and GP Surgery
7.3. Length of NAT-C consultations; and actions taken to meet identified unmet need (including referrals to health professionals and/or services) from the completed NAT-C

Overall trial start date

01/07/2019

Overall trial end date

31/05/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

GENERAL PRACTICES:
1. Willing to be trained and to offer and use the NAT-C, if so allocated, for all recruited patients
2. Willing to commit to trial procedures:
2.1. Supporting screening and inviting patients to participate
2.2. Allowing researchers access to the GP Surgery to support the study
3. Capacity to recruit approximately 20 patients
4. Written informed consent provided by practice manager or deputy

PATIENTS:
1. Adults (aged 18 and above)
2. Diagnosis of active cancer (receiving anti-cancer treatment both with curative or palliative intent; managed with “watch and wait”; recurrent or metastatic; or inoperable) Note: anti-cancer treatment includes any treatment designed to modify the growth of the cancer, such as chemotherapy, immunotherapy, hormone therapy, radiotherapy, or surgery
3. Willing and able to complete questionnaires at the trial follow-up schedule (able to complete trial measures
4. Provision of written or observed verbal informed consent.
5. Sufficient knowledge of the English language to provide informed consent and complete trial questionnaires. The use of an appropriate translator/interpreter is allowed

CARERS:
1. Adults (aged 18 and above)
2. Nominated by the patient
3. Able to complete trial measures
4. Written or observed verbal informed consent
5. Sufficient knowledge of the English language to provide informed consent and complete trial questionnaires. The use of an appropriate translator/interpreter is allowed

PROCESS EVALUATION - CLINICIANS:
1. Any clinician who has received NAT-C training (survey 1)
2. Any clinician who has delivered the NAT-C intervention (survey 2)
3. Any clinician who has received NAT-C training and/or delivered the NAT-C intervention (interview)

PROCESS EVALUATION - OTHER GP STAFF:
1. Practice management and administrative staff in participating intervention practices

PROCESS EVALUATION - KEY STAKEHOLDERS:
1. Identified by the research team or clinical experts as having a key role in health policy and commissioning, relevant to cancer care in primary care

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1,080; UK Sample Size: 1,080

Participant exclusion criteria

GENERAL PRACTICES:
1. Locum GPs who work across general practices and registrars due to leave the practice before the end of the trial will be excluded to avoid potential contamination
2. GP Surgeries with existing or planned (within the recruitment period of the trial) systematic implementation of cancer care review services/holistic needs assessments, which have the potential to significantly overlap with the NAT-C (as determined by the CI & GP hub leads), will be excluded.

PATIENTS:
1. In complete remission (no clinical or radiological evidence of cancer, and at least one-month post anti-cancer treatments)
2. With basal cell carcinoma
3. Living in a care home or other institutional setting
4. Within one month of receiving their initial cancer diagnosis

CARERS:
1. Paid carers

PROCESS EVALUATION - CLINICIANS:
1. Clinicians on Usual Care arm of the study

PROCESS EVALUATION - OTHER GP STAFF:
1. Practice management and administrative staff on Usual Care arm of the study

Recruitment start date

01/09/2020

Recruitment end date

31/05/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Clinical Trials Research Unit Leeds Institute of Clinical Trials Research Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Hull

Sponsor details

Research and Innovation
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom
+44 (0)1482 462352
Researchgovernance@hull.ac.uk

Sponsor type

University/education

Website

http://www2.hull.ac.uk/

Funders

Funder type

Charity

Funder name

Yorkshire Cancer Research; Grant Codes: H423

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 in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. CTRU-DataAccess@leeds.ac.uk. Data will be shared according to a controlled-access approach. Data will only be shared for participants who have given consent to use of their data for secondary research. Requests will be reviewed by relevant stakeholders. No data will be released before an appropriate agreement is in place setting out the conditions of release.

Intention to publish date

30/05/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/03/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).