Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Dr Chloe Grimmett


Contact details

University Road
SO17 1BJ
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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


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

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


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


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.

Intervention type



Not Applicable

Drug names

Primary outcome measure

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


Reason abandoned (if study stopped)


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

Participant type


Age group




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

United Kingdom

Trial participating centre

University of Southampton
SO17 1BJ
United Kingdom

Sponsor information


Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Macmillan Cancer Support (UK)

Alternative name(s)

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

Basic results (scientific)

Publication list

2013 protocol in
2015 results in
2015 results in

Publication citations

  1. Protocol

    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.

  2. Results

    Myall M, May CR, Grimmett C, May CM, Calman L, Richardson A, Foster CL, RESTORE: an exploratory trial of a web-based intervention to enhance self-management of cancer-related fatigue: findings from a qualitative process evaluation, BMC Med Inform Decis Mak, 2015, 15, 1, 94.

Additional files

Editorial Notes

05/12/2017: internal review. 09/12/2015: Publication reference added.