Condition category
Cancer
Date applied
03/10/2012
Date assigned
05/10/2012
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Chloe Grimmett

ORCID ID

Contact details

University Road
Southampton
SO17 1BJ
United Kingdom
restore1@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12769

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

Acronym

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

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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: All Cancers/Misc Sites; Disease: All

Intervention

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

Other

Phase

Not Applicable

Drug names

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

13/09/2012

Overall trial end date

28/06/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

13/09/2012

Recruitment end date

28/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Road
Southampton
SO17 1BJ
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom
sharon.atwill@uhs.nhs.uk

Sponsor type

Hospital/treatment centre

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 provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23786716

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.

Additional files

Editorial Notes