Condition category
Cancer
Date applied
16/03/2012
Date assigned
16/03/2012
Last edited
17/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes