CANAssess 2: Cancer Patients' Needs Assessment in Primary Care – A Cluster Randomised Controlled Trial
Neoplasms of uncertain or unknown behaviour
Current interventions as of 01/03/2022: 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/text message introducing them to the study, with the Participant Information Sheet, the Carer Information Sheet, and a reply form enclosed/available to view on the CANAssess website. Patients are encouraged to return the reply form, using the pre-paid envelope provided, indicating whether they would like to take part or not, or, to express their interest on the CANAssess website. 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, or to arrange a phone/video call where face-to-face is not possible. 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 or phone/video call, if happy to do so. During the visit or phone/video call, the researcher will screen the patient/patient and their carer to confirm they are eligible to take part. If eligible, the researcher will gain informed consent and collect
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 years 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 years 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
Current exclusion criteria as of 01/03/2022: GP surgeries that do not meet the inclusion criteria 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 only 3. Living in a care home or other institutional setting 4. Within 1 month of receiving their initial cancer diagnosis CARERS: 1. Employed to look after the patient PROCESS EVALUATION - CLINICIANS: 1. Clinicians on the Usual Care arm of the study PROCESS EVALUATION - OTHER GP STAFF: 1. Practice management and administrative staff on the Usual Care arm of the study Previous 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 1-month post anti-cancer treatments) 2. With basal cell carcinoma 3. Living in a care home or other institutional setting 4. Within 1 month of receiving their initial cancer diagnosis CARERS: 1. Paid carers PROCESS EVALUATION - CLINICIANS: 1. Clinicians on the Usual Care arm of the study PROCESS EVALUATION - OTHER GP STAFF: 1. Practice management and administrative staff on the Usual Care arm of the study