Plain English Summary
Dr Chloe Grimmett
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
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
NRES Committee South Central Oxford A, First MREC approval date 18/07/2012, ref: 12/SC/0374
Randomised; Interventional; Design type: Prevention, Process of Care
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All
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 measures
Test the value (provide proof of concept) of the intervention, measured using questionnaire (validated method) which is completed by the participants
Secondary outcome measures
No secondary outcome measures
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Planned Sample Size: 125; UK Sample Size: 125
Participant 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.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Southampton University Hospitals NHS Trust (UK)
Macmillan Cancer Support (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23786716
Grimmett C, Armes J, Breckons M, Calman L, Corner J, Fenlon D, Hulme C, May CM, May CR, Ream E, Richardson A, Smith PW, Yardley L, Foster C, RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial., Trials, 2013, 14, 184, doi: 10.1186/1745-6215-14-184.