Neoplasms of uncertain or unknown behaviour Cancer Neoplasms of uncertain or unknown behaviour
Conditions
Interventions
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 usua
Sponsors
University of Hull
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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 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 policy and commissioning, relevant to cancer care in primary care
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unmet need identified in any domain in the Supportive Care Needs Survey Short Form 34 (SCNS-SF34) at 3 months post-registration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma McNaught
Outcome results
None listed