Delivery of cancer systemic therapy in patient's home, outreach surgery and hospital day unit

ISRCTN	ISRCTN66219681
DOI	https://doi.org/10.1186/ISRCTN66219681
Secondary identifying numbers	5700

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/trial-looking-at-comparing-the-delivery-of-treatment-for-cancer-in-the-community-and-hospital-OUTREACH

Contact information

Mrs Victoria Wood
Scientific

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Email	victoria.wood@addenbrookes.nhs.uk

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised trial comparing delivery of cancer systemic therapy in three different settings: patient's home, outreach surgery and hospital day unit
Study 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.
Ethics approval(s)	Cambridgeshire 2 Research Ethics Committee approved in August 2008 (ref: 08/H0308/130)
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
Primary outcome measure	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 study start date	01/11/2008
Overall study end date	31/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 390; UK sample size: 390
Total final enrolment	97
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 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

England
United Kingdom

Study participating centre

Addenbrookes Hospital

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Website	http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Government

Research for Patient Benefit Programme (ref: PB-PG-0107-12101)
Government organisation / National government

Alternative name(s): NIHR Research for Patient Benefit Programme, RfPB
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/09/2013		Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
24/02/2011: The anticipated end date for this trial has been updated from 01/12/2009 to 31/03/2011.