Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Beverly Clayton
ORCID ID
Contact details
Level 03
Bexley Wing
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom
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b.a.clayton@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11496
Study information
Scientific title
ALLograft INformation EXchange (ALLINEX) - phase three: A randomised pilot study of standard care versus standard care plus access to the ALLINEX website
Acronym
ALLINEX
Study hypothesis
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
NRES Committee East Midlands - Nottingham 1 First MREC approval date 08/11/2011, ref: 11/EM/0407
Study design
Randomised; Interventional; Design type: Not specified
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
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
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
18/01/2012
Overall trial end date
29/06/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 40; UK Sample Size: 40
Participant 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
Recruitment start date
18/01/2012
Recruitment end date
29/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James's Institute of Oncology
Leeds
LS9 7TF
United Kingdom
Funders
Funder type
Charity
Funder name
Macmillan Cancer Support (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 expected to be available
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24330318
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26215187