Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Plain English Summary under review with external organization

Trial website


Contact information



Primary contact

Dr Ann Pope


Contact details

Cancer Research (UK) Clinical Trials Unit
School of Cancer Sciences
University of Birmingham
B29 2TT
United Kingdom
+44 (0)121 414 6372



Additional contact

Dr Sam H. Ahmedzai


Contact details

c/o Trial Co-ordinator
Cancer Research (UK) Clinical Trials Unit
School of Cancer Sciences
University of Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 6372

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 11/108/06; sponsor's ref : STH17019; University of Birmingham ref : LU3006

Study information

Scientific title

A phase III randomised trial, with integral feasibility stage, to assess changes in quality of life and survival in patients being referred for early than versus standard specialist palliative care on being diagnosed with stage IV non-small cell lung cancer.



Study hypothesis

Palliative care services in the UK have have traditionally been provided for patients with advanced cancer by local and national independent charitable organisations. Recent progress in anticancer treatments means that increasingly patients with advanced disease may still be receiving active interventions into the late stages of disease. Thus it is important for both the National Health Service and other providers to undertake research into new models of care in advanced cancer, in which anticancer treatment and patient/family-directed supportive and palliative care services are simultaneously provided.

To help direct supportive and palliative care interventions, the National Cancer Action Team has recommended that all patients with cancer should receive Holistic Needs Assessment (HNA) at key points of their trajectory from diagnosis, after primary treatment, through continuing disease into end of life care or into survivorship.

As patients with advanced non-small cell lung cancer (NSCLC) often have a high symptom burden at diagnosis this patient group is in particular need of HNA at the point of diagnosis as well as through their ongoing care. Holistic needs include not only physical symptoms but also psychological, social, spiritual, financial issues; problems with independent living; concerns about treatments and side-effects; and information needs. Many services are not yet using any formal means of assessing holistic needs though there is a range of HNA tools available with the Distress Thermometer/Concerns Checklist or the Sheffield Profile for Assessment and Referral for Care (SPARC) most commonly used in the UK (Ahmedzai et al., 2008).

A single-centre study in USA found that patients with advanced NSCLC randomised to early palliative care had improved quality of life parameters and also achieved a longer survival time compared to patients who had palliative care according to standard procedures (Temel et al, 2010). The SPECIAL trial has been designed to address the question of whether early referral to palliative care services in the UK achieves the same range of benefits as those observed in the US study, given that the availability, structure and funding of palliative care are so different in the two countries. It further asks the question whether a formal holistic needs assessment enhances the referral to palliative care.

References :
Ahmedzai SH, K.G., Rogers E, Noble B, SPARC: a holistic screening questionnaire for palliative and supportive care needs. J Palliat Care 2008. 24(3): p. 194-195.
Temel, J.S., et al., Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med, 2010. 363(8): p. 733-42.

More details can be found at
Protocol can be found at

Ethics approval

UK REC North West – Greater Manchester (West), 22/05/2015, ref: 15/NW/0324

Study design

Phase III randomised controlled trial with integral feasibility stage (non-randomised)

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Patient's and Carers' information sheet is not available in web format; please use the contact details below to request the relevant patient information sheet


Stage IV non-small cell lung cancer; specialist palliative care


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 completed by the patient to be sent with the referral letter to specialist palliative care (SPC), if and when this occurs).

Randomised trial:
Study arms:
Arm A : Standard of care (i.e., standard referral to SPC, if patient is willing)
Arm B : sub-randomisation
Arm B1 : Early SPC referral + standard of care
Arm B2 : Early SPC referral + standard of care + SPARC assessment

Intervention type



Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

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.

Participant type


Age group




Target number of participants

Feasibility study: 60. Randomised trial: at least 525.

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Weston Park Hospital
S10 2JF
United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde
Stobhill Hospital
G12 0XH
United Kingdom

Trial participating centre

University Hospital Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
B15 2TH
United Kingdom

Trial participating centre

NHS Lanarkshire
Hairmyres Hospital
East Kilbride
G75 8RG
United Kingdom

Trial participating centre

Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Doncaster Royal Infirmary
United Kingdom

Trial participating centre

Sandwell and West Birmingham Hospitals NHS Trust
City Hospital
B18 7QH
United Kingdom

Sponsor information


Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor details

Royal Hallamshire Hospital
Glossop Road
S10 2JF
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

The final results of the trial will be discussed with participating hospitals’ investigators and a report will be submitted for peer review and publishing in a medical journal. The anticipated date of publication of trial results is 2020.

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/07/2016: Internal review.