ALLograft INformation EXchange (ALLINEX): Standard care versus standard care plus access to the ALLINEX website

ISRCTN	ISRCTN33172094
DOI	https://doi.org/10.1186/ISRCTN33172094
Secondary identifying numbers	11496

Submission date: 16/03/2012
Registration date: 16/03/2012
Last edited: 17/08/2015

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 of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-support-website-people-who-have-had-stem-cell-transplant-allinex

Contact information

Ms Beverly Clayton
Scientific

Level 03, Bexley Wing
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom

Email	b.a.clayton@leeds.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Not specified
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Internet/virtual
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	ALLograft INformation EXchange (ALLINEX) - phase three: A randomised pilot study of standard care versus standard care plus access to the ALLINEX website
Study acronym	ALLINEX
Study objectives	Survival for adult patients receiving allogeneic Haemopoietic Stem Cell Transplant (HSCT) is improving but many will experience challenges particularly associated with chronic Graft versus Host Disease (cGvHD). Allogeneic HSCT patients are followed up in tertiary care, being seen less frequently as they recover. Although recommendations have been made for assessment and support for HSCT patients on follow up, some patients do not access the care they want or need. There has been an increase in the use of technologies in providing support in health care. Allogeneic HSCT patients tend to be under the age of 65years and therefore are likely to be users of the internet. This is a group of patients who might benefit from a specifically designed website for use as an adjunct to their standard follow up care. Such a website could include information endorsed by their clinical team, the means to contact their clinical team and the facility for them to chat to each other via a secure forum. The aim of this study is to assess the acceptability and feasibility of introducing a specifically designed website for use in the allogeneic adult HSCT service as an adjunct to standard care. In this pilot we will aim to recruit suffiicent participants to allow for a minimum of 20 patients in each arm to complete the study to fulfil minimum requirements of a total of 30 participants recommended by Browne for randomised pilot studies. We will aim to recruit more than this minimum to provide the best estimate for primary outcome for a larger trial. More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11496
Ethics approval(s)	NRES Committee East Midlands - Nottingham 1 First MREC approval date 08/11/2011, ref: 11/EM/0407
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: All
Intervention	Intervention (access to website) plus standard care versus standard care. Consenting patients will complete baseline measures prior to randomisation. Participation time is twelve weeks. Consultations with the clinician will be audio-recorded. Website activity will be tracked. At six weeks the intervention arm will complete a Patient Technology Acceptance Survey. After twelve weeks all will complete outcome measures and a use of service questionnaire. The intervention arm will complete a feedback questionnaire concerning the website. Clinicians will take part in a debriefing interview concerning use of the website as an adjunct to standard care. Contact between patients and clinicians will be reviewed during the study period.
Intervention type	Other
Primary outcome measure	Feasibility and acceptability - Establish feasibility and acceptability of a specifically designed website as an adjunct to routine measured at 12 weeks
Secondary outcome measures	1. Patient behaviour - Demonstrate change in patient behaviour 2. Patient well-being - Enhancement of patient well-being compared to standard care group. Measured at 6 weeks
Overall study start date	18/01/2012
Completion date	29/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 40; UK Sample Size: 40
Key inclusion criteria	1. Having undergone allogeneic HSCT 2. Under specialist HSCT care 3. English literate 4. Aged 18 or over 5. Access to the internet Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified
Key exclusion criteria	1. Unable to provide informed consent to participate 2. Have cognitive impairment or communication difficulties which are incompatible with the study 3. Participation in the study is judged to be inappropriate on clinical grounds
Date of first enrolment	18/01/2012
Date of final enrolment	29/06/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St James's Institute of Oncology

Leeds
LS9 7TF
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Faculty of Medicine and Health
Academic Unit of Musculoskeletal and Rehabilitation Medicine
36 Clarendon Road
Leeds
LS2 9NZ
England
United Kingdom

"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Charity

Macmillan Cancer Support (UK)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2014		Yes	No
Results article	results	01/05/2016		Yes	No