SPECIAL: Standard or Palliative Care in Advanced Lung Cancer - Does early referral of patients with metastatic non-small cell lung cancer to UK specialist palliative care services make a difference in their quality of life or survival?

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])

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 visits
2. Satisfaction with patient participant’s end of life care: assessed using the CODE™ instrument, completed by the carer (if willing) approximately 3 months post bereavement