Condition category
Cancer
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
06/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Victoria Wood

ORCID ID

Contact details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
victoria.wood@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5700

Study information

Scientific title

A randomised trial comparing delivery of cancer systemic therapy in three different settings: patient's home, outreach surgery and hospital day unit

Acronym

OUTREACH

Study hypothesis

This is a randomised, prospective controlled trial to determine the true benefits and costs of delivering systemic therapy to cancer patients in two different community settings - at home or in an outreach surgery - compared with standard delivery of treatment in hospital facilities, in terms of: patient perceived benefits, cost-effectiveness and patient safety.

As of 24/02/2011 the anticipated end date for this trial has been updated from 01/12/2009 to 31/03/2011.

Ethics approval

Cambridgeshire 2 Research Ethics Committee approved in August 2008 (ref: 08/H0308/130)

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All

Intervention

The trial runs for 4 months with no patient follow up after that period. Three arms of the trial are treatment at home, treatment at a designated outreach surgery and at hospital day unit - this can be described as the control arm of the trial.

Study entry: single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient perceived benefits, measured by questionnaire at 0 weeks, 4 weeks, 8 weeks and 12 weeks with an optional 24 weeks visit.

Secondary outcome measures

1. Additional patient perceived benefits, measured by questionnaire at 0 weeks, 4 weeks, 8 weeks and 12 weeks with an optional 24 weeks visit
2. Impact on costs, measured by questionnaire at 0 weeks and 12 weeks

Overall trial start date

01/11/2008

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any cancer patient being treated at either Cambridge University Hospital (CUH) or West Suffolk Hospital (WSH)
2. Prepared to be considered for treatment at home or at one of the three defined outreach surgeries as alternatives to standard hospital treatment
3. Life expectancy greater than 6 months
4. Either commencing a course of treatment planned to last a minimum of 3 months, or having already commenced a course of treatment which is planned to continue for a minimum of 3 further months
5. Course of treatment may be aimed at cure, palliation or supportive care
6. Has hot and cold running water
7. Has an indoor toilet
8. Has a working telephone
9. Is not dependant on hospital transport
10. Able to give written informed consent
11. Aged greater than 18 years
12. No other acute or chronic medical or psychiatric conditions which might have a significant influence on choice of the appropriate location of the patient to receive treatment
13. Easter Cooperative Oncology Group (ECOG) performance status less than 2; if ECOG PS 2, there must be a second individual living in the home who functions as a carer
14. Either sex, lower age limit of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 390; UK sample size: 390

Participant exclusion criteria

1. Any patient receiving an unlicensed cancer drug treatment as part of a clinical trial, where the drug is defined as an investigational medical product (IMP), unless the trial itself has received ethics and research and development approval to be conducted in designated community settings used in the Outreach Trial
2. Patients with language barriers or communication difficulties whose safety might potentially be compromised by entry into this trial (in the opinion of the Investigator)
3. Any patient, where, in the opinion of the investigator, entry into this trial would give cause for concern regarding patient safety

Recruitment start date

01/11/2008

Recruitment end date

31/03/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0107-12101)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23989945

Publication citations

  1. Results

    Corrie PG, Moody AM, Armstrong G, Nolasco S, Lao-Sirieix SH, Bavister L, Prevost AT, Parker R, Sabes-Figuera R, McCrone P, Balsdon H, McKinnon K, Hounsell A, O'Sullivan B, Barclay S, Is community treatment best? a randomised trial comparing delivery of cancer treatment in the hospital, home and GP surgery., Br. J. Cancer, 2013, 109, 6, 1549-1555, doi: 10.1038/bjc.2013.414.

Additional files

Editorial Notes