Condition category
Cancer
Date applied
04/05/2011
Date assigned
05/07/2011
Last edited
27/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Bill Noble

ORCID ID

Contact details

Macmillan Senior Lecturer in Palliative Medicine
Sykes House
Little Common Lane
Sheffield
S11 9NE
United Kingdom
+44 (0)114 262 0174 (ext 28)
n.ahmed@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

A feasibility study of an holistic needs assessment questionnaire in a supportive and palliative care service using the Sheffield Profile for Assessment and Referral for Care (SPARC)

Acronym

SPARC

Study hypothesis

The Academic Unit of Supportive Care is undertaking a research study about holistic needs assessment. We are carrying out a study with patients referred for supportive or palliative care, to learn if using the SPARC questionnaire improves their care.

The study aims are:
1. To determine the effect of holistic needs assessment on health related quality of life and self identified concerns in patients referred for supportive and palliative care
2. To determine the effect of holistic needs assessment on interventions, consultations and referrals within supportive and palliative care
3. To measure the difference at baseline assessment between patients identified as cancer survivors, those living with a long term condition and those receiving end of life care, in terms of their concerns, quality of life and need for supportive or palliative care
4. We hope to learn if using SPARC makes a difference in quality of life, and in referrals for help; whether it makes a difference how early on it is used, and whether the experience is different for different groups of patients

Ethics approval

Bradford Research Ethics Committee, REC ref: 10/H1302/88 - approval pending as of 05/05/2011

Study design

Randomised waiting list controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

All patients (cancer and non cancer) referred to the service

Intervention

1. The study will be carried out with in-patients, out-patients and in community settings, to assess whether using the SPARC tool makes a difference to symptoms and concerns, quality of life, needs identified, and being referred for help.
2. SPARC is a multidimensional screening tool which gives a profile of needs to identify patients who may benefit from additional supportive or palliative care, regardless of diagnosis or stage of disease
3. SPARC is intended for use by primary care, hospital teams or other services to improve patient management, either by current professional carers or by referral to a specialist team
4. It covers:
4.1. Physical and psychological symptoms
4.2. Spiritual issues
4.3. Activities/independence
4.4. Family, social and treatment issues
5. Its aim is to identify patients who could benefit from additional supportive or palliative care
6. We will use SPARC in addition to the usual care that people receive
7. Some patients will complete the questionnaire straightaway, others will receive it after a period of two weeks
8. For everyone, care will continue as normal
9. The responses given on the SPARC questionnaire will be followed up by one of the usual care team to ensure that needs identified are addressed
10. Participants will fill in three short research questionnaires as part of the study, repeated after two weeks, four weeks and six weeks
11. Once people have opted to participate in the study, they will be allocated either to the group receiving SPARC straight away, or to the group which receives it after two weeks (randomly decided)
12. A small group of participants will be invited to take part in interviews

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. The difference in score between the patient Measure Yourself Concerns and Wellbeing (MYCAW) on the patient self-scoring visual analogue scale at baseline and the two-week follow up
2. Assuming the changes in the score (baseline to week 2) are normally distributed, a t-test will be carried out to test the null hypothesis that the difference between the intervention and control groups in the mean score on the first symptom nominated on the scale at baseline and two weeks is zero
3. To detect a medium difference between two independent sample means requires a minimum of 64 individuals in each group with scores at baseline and two weeks (Cohen, 1992). Therefore, a total of 128 patients will have to be recruited.
4. In order collect both baseline and follow-up data from 128 patients, 500 patients will be recruited to the study, assuming that approximately one quarter will be able to participate at the two-week follow-up.
5. The calculation for the sample size has taken account of the attrition to be expected in this population overall, although with varied survival rates, we can also expect to recruit sufficient numbers of patients able to give useable follow-up data. The statistical analysis will therefore be predominantly descriptive, with correlations drawn between specific demographic and medical variables with SPARC scores.

Secondary outcome measures

1. The change in scores in the EQ-5D at the two time points
2. Changes in the enablement scores (PEI) at the two time points
3. Comparisons will be made between the intervention group and the waiting list control
4. Outcomes in patients entering the service in different ways, as inpatients where input is requested, as inpatients on the Palliative Care Unit, and as outpatients, will be explored
5. The pattern of actions taken and referrals made as a result of the SPARC screening tool will be examined, by analysis of the clinical record
6. Comparisons will be made regarding MYCAW patient nominated concerns, EQ-5D, and the PEI at baseline between patient groups (long term conditions, cancer survivors, and people needing end of life care)

Overall trial start date

01/01/2010

Overall trial end date

30/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any diagnosis (cancer and non-cancer)
2. Any referral to the service
3. Patients 18 years old or above
4. Patients able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Follow up data from n=128 patients (n=500 patients required taking account of attrition)

Participant exclusion criteria

1. Incapable of giving informed consent
2. Incapable of completing SPARC even with the help of a relative or informal carer
3. Under 18 years old

Recruitment start date

01/01/2010

Recruitment end date

30/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S11 9NE
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

c/o Mr Nisar Ahmed
10-12 Brunswick Street
The University of Sheffield
Sheffield
S11 9NE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Macmillan Cancer Support (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26087472

Publication citations

Additional files

Editorial Notes