ALLograft INformation EXchange (ALLINEX): Standard care versus standard care plus access to the ALLINEX website
| ISRCTN | ISRCTN33172094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33172094 |
| Protocol serial number | 11496 |
| Sponsor | University of Leeds (UK) |
| Funder | Macmillan Cancer Support (UK) |
- 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
Contact information
Ms Beverly Clayton
Scientific
Scientific
Level 03, Bexley Wing
St James's Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom
| b.a.clayton@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Not specified |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Feasibility and acceptability - Establish feasibility and acceptability of a specifically designed website as an adjunct to routine measured at 12 weeks |
| Key secondary outcome measure(s) |
1. Patient behaviour - Demonstrate change in patient behaviour |
| Completion date | 29/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
St James's Institute of Oncology
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
