Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Nov 14:15:94.
doi: 10.1186/s12911-015-0214-y.

RESTORE: an exploratory trial of a web-based intervention to enhance self-management of cancer-related fatigue: findings from a qualitative process evaluation

Affiliations
Randomized Controlled Trial

RESTORE: an exploratory trial of a web-based intervention to enhance self-management of cancer-related fatigue: findings from a qualitative process evaluation

Michelle Myall et al. BMC Med Inform Decis Mak. .

Abstract

Background: Cancer-related fatigue is a distressing symptom experienced by many after cancer treatment. An exploratory randomised controlled trial was conducted to test proof of concept of RESTORE: a web-based tool to enhance self-efficacy to manage cancer-related fatigue. This paper reports findings from a qualitative process evaluation to determine feasibility and acceptability of the intervention and trial processes.

Method: Qualitative process evaluation carried out at the end of the trial to explore participants' experiences using semi-structured telephone interviews with a purposive sample of participants from both trial arms. Normalisation Process Theory informed data collection and analysis. Analysis involved directed content analysis within a Framework Approach.

Results: Nineteen participants took part. They understood the purpose and requirements of the trial and identified beneficial outcomes from taking part. For the majority, the work of the trial was easily accommodated into daily routines and did not require new skills. There were mixed views about the value of the information provided by RESTORE, depending on time since diagnosis and treatment. Personal factors, constraints of the intervention, and environmental context inhibited the integration and embedding of RESTORE into everyday life. Access to the intervention at an early stage in the treatment trajectory was important to effective utilisation, as were individual preferences for delivery of information.

Conclusion: The theoretical foundations of the intervention were sound. Participants derived benefits from the intervention but barriers to implementation and integration suggest that RESTORE and the trial processes require some modification before testing in a full trial.

Trial registration: ISRCTN67521059 (10(th) October 2012).

PubMed Disclaimer

Similar articles

Cited by

References

    1. Oakley A, Strange V, Bonell C, Allen E, Stephenson J, Team RS. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006;332(7538):413–6. doi: 10.1136/bmj.332.7538.413. - DOI - PMC - PubMed
    1. Murtagh MJ, Thomson RG, May CR, Rapley T, Heaven BR, Graham RH, et al. Qualitative methods in a randomised controlled trial: the role of an integrated qualitative process evaluation in providing evidence to discontinue the intervention in one arm of a trial of a decision support tool. Qual Saf Health Care. 2007;16(3):224–9. doi: 10.1136/qshc.2006.018499. - DOI - PMC - PubMed
    1. Armstrong R, Waters E, Moore L, Riggs E, Cuervo LG, Lumbiganon P, et al. Improving the reporting of public health intervention research: advancing TREND and CONSORT. J Public Health (Oxf) 2008;30(1):103–9. doi: 10.1093/pubmed/fdm082. - DOI - PubMed
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655. - DOI - PMC - PubMed
    1. May CR, Finch T, Ballini L, MacFarlane A, Mair F, Murray E, et al. Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit. BMC Health Serv Res. 2011;11:245. doi: 10.1186/1472-6963-11-245. - DOI - PMC - PubMed

Publication types

Associated data