None listed
Conditions
Brief summary
This study aims to evaluate the effectiveness of a symptom assessment supported by a clinical care pathway for adult patients with liver cancer who are attending ambulatory liver cancer clinics. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an active liver cancer and you are attending one of the participating liver cancer and palliative care centres as an outpatient (Royal Prince Alfred Hospital, Westmead Hospital, Liverpool Hospital and St George Hospital). Unpaid carers for eligible patients will also be invited to participate. Study details Depending upon the hospital/clinical care centre that participants would normally attend they will either continue to be treated per the current care guidelines or they will be invited to participate in the intervention model of care. Participants who attend either of the usual care or intervention centres will be asked to complete two questionnaires about their symptoms and quality of life at each of their scheduled visits, and will be provided with instructions that they can raise any symptom concerns with their treating clinician at their appointment. Completion of the questionnaires is anticipated to take 10-15 minutes. Carers of participants who attend one of the intervention centres will also be asked to complete a questionnaire about their support needs. For participants and carers who attend one of the intervention centres, the questionnaire responses will be assessed against a set of criteria. If the participant is experiencing a decrease in their quality of life, an increase in their symptoms and/or severity of symptoms, or the carer has identified that their support needs are not being met this will trigger a referral to be sent to palliative care services. Participants who receive this referral will also be reviewed by a Palliative Medicine Specialist for further clinical review so that they may be provided with personalised symptom management, other supportive management and interdisciplinary referral as required. It is hoped this research will determine whether implementation of a symptom and needs-based assessment framework for additional palliative care services is feasible and whether this framework has a positive impact on the quality of care of patients with liver cancer. If the assessment framework model of care is seen to have a positive impact, it may be expanded to include a greater number of clinic care centres which would allow further patients with liver cancer to receive more personalised care.
Interventions
The intervention sites will implement the model as standard practice within their ambulatory care clinic model. As this is a cluster based trial with patient allocation at level of hospital, patients will be allocated to intervention or control based upon attendance at their regular clinic. This model will require patients to perform Liver-specific Edmonton Symptom Assessment scale, and European Organisation for Research and Treatment of Cancer Quality of Life questionnaire, and their carers t
The intervention sites will implement the model as standard practice within their ambulatory care clinic model. As this is a cluster based trial with patient allocation at level of hospital, patients will be allocated to intervention or control based upon attendance at their regular clinic. This model will require patients to perform Liver-specific Edmonton Symptom Assessment scale, and European Organisation for Research and Treatment of Cancer Quality of Life questionnaire, and their carers to perform a Carer-Support Needs Assessment Tool (CSNAT) questionnaire at their ambulatory care appointments for liver cancer every 3 months as part of their regular scheduled follow up. These questionnaires take around 10-15 minutes to complete. Based on the agreed framework, if a patient’s symptom reaches a certain threshold, this will trigger referral to palliative care services. Palliative care services will review these patients and carers, and institute standard management and treatment, as required. These questionnaires will be entered electronically into REDCap on iPads at each of the clinic sites. Automatic generation of notification of moderate-severe symptoms (liver specific ESAS >4) at intervention sites will be emailed to study co-ordinator and HCC clinical nurse consultants, who will notify the relevant specialist to trigger referral to palliative care. Palliative care services will entail a comprehensive clinical review and tailored symptom management, with additional supportive management and interdisciplinary referral as per the standard palliative care clinical guidelines. Completed liver specific ESAS forms will be monitored, as well as palliative care referral rates from intervention sites will be utilised to review adherence to the study protocol.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Sites will be ambulatory liver cancer clinics at participating hospitals. Participants will include patients, carers and centre staff at each site. Inclusion criteria: Liver cancer patients 1. Attend a participating liver cancer and palliative care centre as an outpatient during the study period 2. Have a diagnosis of current active liver cancer 3. Be able to self-complete a 0-10 liver-specific Edmonton Symptom Assessment scale (ESAS) Inclusion criteria for carers will be: 1. Identified by a patient who has completed the symptom and needs assessment as providing them with substantial emotional and practical support in an unpaid capacity 2. Have spoken and written English proficiency sufficient to complete the Carer-Support Needs Assessment Tool (CSNAT). Inclusion criteria for centre staff : 1. Employed full- or part-time at a participating cancer or palliative care centre in a role that provides clinical care to patients with liver cancer 2. Provide written informed consent.
Exclusion criteria
Exclusion criteria for liver cancer patients: 1. Patients with Barcelona Clinic Liver Cancer (BCLC) stage A disease and no underlying liver disease 2. Patients with advanced disease (BCLC D) where inpatient care or direct referral to palliative care has been performed prior to ambulatory liver cancer clinic appointment. 3. Those who opt-out of completing the ESAS and needs assessment as part of their clinic assessment. 4. Participation at another centre taking part in the trial; 5. Documented as having cognitive impairment that would preclude capacity to give informed consent. Exclusion criteria for carers: 1. Those who opt-out of completing the needs assessment as part of the assessment of the person for whom they are providing care.
Outcome results
None listed