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

Myall et al. BMC Medical Informatics and Decision Making (2015) 15:94 DOI 10.1186/s12911-015-0214-y RESEARCH ARTICLE Open Access RESTORE: an exploratory trial of a web-based intervention to enhance self-management of cancer-related fatigue: findings from a qualitative process evaluation Michelle Myall1, Carl R. May1, Chloe Grimmett1, Christine M. May1, Lynn Calman1, Alison Richardson1,2 and Claire L. Foster1* 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 (10th October 2012). Keywords: Process evaluation, Normalisation Process Theory, Cancer survivors, Self-efficacy, Oncology, Cancer * Correspondence: ; 1 University of Southampton, Faculty of Health Sciences, Southampton SO17 1BJ, UK Full list of author information is available at the end of the article © 2015 Myall et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Myall et al. BMC Medical Informatics and Decision Making (2015) 15:94 Page 2 of 9 Background Process evaluations are an important part of randomised controlled trials (RCT), particularly complex healthcare interventions [1–5]. They increase understanding of participants’ views of the intervention and trial processes, so that they can be modified prior to a large-scale trial. A theoretical approach to a process evaluation supports understanding and explanation of the processes involved during the implementation of an intervention and its potential integration into everyday practice [6]. This paper reports findings from a qualitative process evaluation of RESTORE, an exploratory RCT of a web-based intervention to enhance self-efficacy to manage cancer-related fatigue (CRF) following primary cancer treatment [7]. CRF is one the most common and distressing symptoms experienced by people affected by cancer with no known effective pharmacological treatment [8]. There is growing support for physical activity [9] and interventions that include psychosocial support and cognitive behaviour therapy in improving CRF [10], however access to existing programmes is limited and such programmes are, most often, resource intensive. Access to the internet is growing rapidly, particularly amongst older adults [11] and increasingly the internet is being used to promote health behaviour change [12] and deliver self-management interventions for long-term conditions [13, 14]. Two existing publications describe web-based interventions to improve CRF [15, 16]. However none have considered the importance of selfefficacy to manage CRF or include any evidence of process evaluation. Full details of the development, content and trial protocol of RESTORE have been published elsewhere [17]. Briefly, the content of RESTORE was theoretically informed [18, 19]. It consists of 5 sessions, completed independently by participants, at weekly intervals, bringing together clinical knowledge and lay examples from survivors. Sessions 1-2 are compulsory and introduce CRF (including prevalence, definitions and aetiology), and the concept of setting SMART goals. For the following 3 weeks participants then choose from sessions on i) diet, sleep, exercise, home and work life; ii) thoughts and feelings; iii) talking to others. Participants can complete all sessions, or spend more time on a session/s most relevant to them. A choice of structured activities, such as goal setting and keeping a fatigue diary are provided throughout the intervention, in addition to automated tailored feedback on achievement of goals and video clips of patients’ stories. During the exploratory RCT participants, who had completed primary treatment within the last 5 years, were randomised to receive either RESTORE or a leaflet comparator. The process evaluation was conducted at the end of the trial. The aim was to understand the work required for participants; establish if the concept and theoretical foundations of the intervention were sound; identify barriers to integrating and embedding the intervention into everyday routines; and ascertain whether and how implementation needed to be improved. Evaluation approach Normalisation Process Theory (NPT) provided the theoretical lens for the evaluation [20, 21]. NPT is an action theory concerned with what people do rather than their views and beliefs. By focusing on collective, distributed patterns of action NPT seeks to explain how and why things become, or do not become, embedded into everyday practice [21]. NPT assists “in understanding and explaining the dynamic processes that are encountered during the implementation of complex interventions and technological or organisational innovations in healthcare” [5]. In NPT, 4 theoretical constructs shape the processes of successful intervention implementat (...truncated)