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?

ISRCTN	ISRCTN13337289
DOI	https://doi.org/10.1186/ISRCTN13337289
Secondary identifying numbers	HTA 11/108/06; sponsor's ref : STH17019; University of Birmingham ref : LU3006

Submission date: 02/06/2015
Registration date: 17/06/2015
Last edited: 24/08/2022

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Study website

Contact information

Dr Ann Pope
Public

Cancer Research (UK) Clinical Trials Unit
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B29 2TT
United Kingdom

Phone	+44 (0)121 414 6372
Email	SPECIAL@trials.bham.ac.uk

Dr Sam H. Ahmedzai
Scientific

c/o Trial Co-ordinator
Cancer Research (UK) Clinical Trials Unit
School of Cancer Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 6372
Email	SPECIAL@trials.bham.ac.uk

Study information

Study design	Phase III randomised controlled trial with integral feasibility stage (non-randomised)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant 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
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 acronym	SPECIAL
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 http://www.nets.nihr.ac.uk/projects/hta/1110806 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/117428/PRO-11-108-06.pdf
Ethics approval(s)	UK REC North West – Greater Manchester (West), 22/05/2015, ref: 15/NW/0324
Condition	Stage IV non-small cell lung cancer; specialist palliative care
Intervention	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	Other
Primary outcome measure	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 study start date	01/03/2014
Overall study end date	03/03/2016
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Feasibility study: 60. Randomised trial: at least 525.
Total final enrolment	4
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 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.
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	01/09/2015
Recruitment end date	03/03/2016

Locations

Countries of recruitment

England
Scotland
United Kingdom

Study participating centres

Sheffield Teaching Hospitals NHS Foundation Trust

Weston Park Hospital
Sheffield
S10 2JF
United Kingdom

NHS Greater Glasgow and Clyde

Stobhill Hospital
Glasgow
G12 0XH
United Kingdom

University Hospital Birmingham NHS Foundation Trust

Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Sandwell and West Birmingham Hospitals NHS Trust

City Hospital
Birmingham
B18 7QH
United Kingdom

Sponsor information

Sheffield Teaching Hospitals NHS Foundation Trust
Hospital/treatment centre

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom

Website	http://sheffieldclinicalresearch.org
"ROR"	https://ror.org/018hjpz25

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	The Trial Management Group plan to publish an article regarding the difficulties encountered in setting up this complex trial, to be submitted for peer review and publication in 2017.
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol (other)		08/04/2016	12/04/2022	No	No
HRA research summary			26/07/2023	No	No

Editorial Notes

24/08/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2019 to 03/03/2016.
2. The total final enrolment number has been added.
3. The IPD sharing summary has been changed from "Available on request" to "Not expected to be made available".
12/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2018 to 03/03/2016.
2. A protocol link has been added.
11/11/2016: The study was abandoned on 01/03/2016 as participant recruitment did not meet required target set by funding body.