Stage IV non-small cell lung cancer
Conditions
Interventions
Feasibility study :
All patients will be asked to complete a Sheffield Profile for Assessment and Referral for Care (SPARC) holistic needs questionnaire (a copy of the last form comple
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients : 1. Any adult (=18 years) patient with newly diagnosed stage IV non-small cell lung cancer, with histologically confirmed diagnosis 2. ECOG performance score 0-3 Carers: Must be caring for a patient participant of the trial. NB. A patient's involvement in the trial is not dependent upon having a carer willing and able to take part also.
Exclusion criteria
Exclusion criteria: 1. ECOG performance score 4 2. Prognosis of =2 weeks 3. Participation in another local competing supportive or palliative care trial 4. Dementia, delirium or other lack of capacity or communication which renders the patient unable to participate in the trial 5. Any other psychological disorder which, in the view of the investigator, renders the patient unable to participate 6. Unable to communicate in English or with the use of an interpreter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility study : 1. The number of potentially eligible patients and the proportion consenting to registration in the three participating centres, and to evaluate adequate acceptance rate for patient willingness to be randomised 2. Patient pathway planning and scoping for Randomised Controlled Trial (RCT) adaptation 3. Feasibility of using quality of life (QoL) and resource use questionnaires To inform design for large scale RCT. Randomised trial: To compare the two treatment arms in terms of the two co-primary outcome measures: 1. Global Health Status Score (GHSS) at 3 months after trial entry 2. Quality-adjusted survival time (QAS) over 6 months (also referred to as Quality Adjusted Life Years [QALY]) | — |
Secondary
| Measure | Time frame |
|---|---|
| Randomised trial: 1. Overall survival: defined as the time from randomisation to death (due to any cause) or to date last seen for those not known to have died 2. Anxiety/depression: as measured using the patient-completed HADS questionnaire at baseline, 3 and 6 months 3. Pain: as measured using the EORTC QLQ-C30 and –LC13 questionnaires at baseline and subsequent monthly (or three-weekly, treatment regime dependent) clinic visits 4. Health Economics, Cost-effectiveness and Resource Use: 4.1. Number of days spent in hospital/hospice: obtained from patient records. Duration defined as time from admission to discharge 4.2. Use, or not, of medical interventions in last month of life: details to be collected from patient records. The patient subgroup will be defined as those for which death was observed 4.3. Intensive Therapy Unit (ITU) admission: the number of patients admitted, the frequency of duration of visits will be obtained from patient records. Duration is defined as the time from admission to discharge from ITU 4.4. Use of Cardio Pulmonary Resuscitation (CPR): obtained from patient records 5. Quality of life: to be assessed using EQ-5D-5L and EORTC QLQ-C30, -LC13 and –BM22 questionnaires at baseline and subsequent monthly (or three-weekly, treatment regime dependent) clinic visits 6. Memory and cognitive ability: will be assessed for consenting participants using the Montreal Cognitive Assessment (MoCA) at baseline, 3 and 6 months 7. Modified Glasgow Prognostic Score (mGPS): will be assessed from blood albumin and CRP results at baseline, 3 and 6 months Secondary outcomes pertaining to family care-givers include: 1. Health Survey: assessment using the SF-12® at baseline and subsequent visits to the clinic corresponding with the patient participant’s vis | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactAnn Pope
Outcome results
None listed