Online intervention to enhance confidence to manage problems associated with cancer related fatigue following primary cancer treatment

ISRCTN	ISRCTN67521059
DOI	https://doi.org/10.1186/ISRCTN67521059
Secondary identifying numbers	12769

Submission date: 03/10/2012
Registration date: 05/10/2012
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-online-support-people-extreme-tiredness-after-cancer-treatment-restore

Contact information

Dr Chloe Grimmett
Scientific

University Road
Southampton
SO17 1BJ
United Kingdom

Email	restore1@soton.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Prevention, Process of Care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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 http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12769
Ethics approval(s)	NRES Committee South Central Oxford A, First MREC approval date 18/07/2012, ref: 12/SC/0374
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
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 study start date	13/09/2012
Overall study end date	28/06/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 125; UK Sample Size: 125
Total final enrolment	163
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 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

England
United Kingdom

Study participating centre

University of Southampton

Southampton
SO17 1BJ
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Email	sharon.atwill@uhs.nhs.uk
"ROR"	https://ror.org/0485axj58

Funders

Funder type

Charity

Macmillan Cancer Support (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	21/06/2013		Yes	No
Results article	results	14/11/2015		Yes	No
Results article	results	01/06/2016		Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
05/12/2017: internal review.
09/12/2015: Publication reference added.