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Online intervention to enhance confidence to manage problems associated with cancer related fatigue following primary cancer treatment
ISRCTN ISRCTN67521059
DOI 10.1186/ISRCTN67521059
ClinicalTrials.gov identifier
EudraCT number
Public title Online intervention to enhance confidence to manage problems associated with cancer related fatigue following primary cancer treatment
Scientific title RESTORE: An exploratory randomised controlled trial of an online intervention to enhance confidence to manage problems associated with cancer related fatigue following primary cancer treatment
Acronym N/A
Serial number at source 12769
Study hypothesis The Macmillan Survivorship Research Group has been funded by Macmillan Cancer Support to undertake a programme of research to understand recovery following primary cancer treatment and develop an internet based resource to support people living with problems following treatment. This study is a fundamental part of the programme.

The purpose of this study is to determine if an online resource called RESTORE which provides clinical information, examples of how others manage, and support with setting personal goals increases confidence to self-manage problems associated with cancer related fatigue.

Cancer-related fatigue is a common problem often reported during chemotherapy and radiotherapy treatment and many people report fatigue persists once treatment is over. Fatigue may have an impact on individuals in a number of ways such as how they feel about themselves, whether and how they engage in everyday activities, and may also affect their relationships with others. This study will test an online resource (RESTORE) with a focus on increasing confidence to manage cancer related fatigue for those people who use the internet, or are willing to use the internet. Participants who use RESTORE will be compared with those receiving a booklet; Macmillan Cancer backup ‘Coping with Fatigue’ in order to assess the effectiveness of RESTORE. Those with access to RESTORE are expected to demonstrate greater confidence to self manage problems associated with cancer related fatigue compared to those receiving the booklet alone.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12769
Lay summary http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-online-support-people-extreme-tiredness-after-cancer-treatment-restore
Ethics approval NRES Committee South Central – Oxford A, First MREC approval date 18/07/2012, ref: 12/SC/0374
Study design Randomised; Interventional; Design type: Prevention, Process of Care
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All
Participants - inclusion criteria 1. Have had a clinical diagnosis of invasive cancer within the last 5 years
2. Have completed or are nearing complement of treatment (surgery/chemotherapy/ radiotherapy) with curative intent
3. Have no evidence of metastatic disease
4. Aged 18+, no upper age limit
5. Are experiencing fatigue: defined as scoring ≥ 4 on a unidimensional 11-point numeric rating scale (NRS) for fatigue
as suggested by the National Comprehensive Cancer Network and/or have low self-efficacy to manage their fatigue <4 on a unidimensional 10 point rating scale.
6. Able to complete written records in English
7. Have access to the internet – at home, from a community resource such as a library or through patients information services linked to health services e.g. Macmillan information services
8. Have or are willing to create an email account
Participants - exclusion criteria 1. In the opinion of a relevant clinician they are unable to give informed consent (e.g. due to severe cognitive impairment
or learning disability)
2. Are too ill to engage in the intervention
3. The intervention will be developed and tested in the English language this means that non-English speakers will be excluded from this study. We would hope to be able to make the intervention accessible in a number of languages once testing is complete and we have established effectiveness.
Anticipated start date 13/09/2012
Anticipated end date 28/06/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned Sample Size: 125; UK Sample Size: 125
Interventions Participants who use online resource (RESTORE) will be compared with those receiving a booklet; Macmillan Cancer backup ‘Coping with Fatigue’

Online intervention to enhance self-efficacy (confidence) to manage problems associated with cancer-related fatigue following primary cancer treatment.
Primary outcome measure(s) Test the value (provide ‘proof of concept’) of the intervention, measured using questionnaire (validated method) which is completed by the participants
Secondary outcome measure(s) No secondary outcome measures
Sources of funding Macmillan Cancer Support (UK)
Trial website
Publications 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23786716
Contact name Dr  Chloe  Grimmett
  Address University Road
  City/town Southampton
  Zip/Postcode SO17 1BJ
  Country United Kingdom
  Email restore1@soton.ac.uk
Sponsor Southampton University Hospitals NHS Trust (UK)
  Address Tremona Road
  City/town Southampton
  Zip/Postcode SO16 6YD
  Country United Kingdom
  Email sharon.atwill@uhs.nhs.uk
Date applied 03/10/2012
Last edited 25/10/2013
Date ISRCTN assigned 05/10/2012
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