Managing fatigue after cancer treatment: development of RESTORE, a web-based resource to support self-management (original) (raw)
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Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015
Cancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial. A multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed in the study. Participants (≥18 years; ≤5 years post treatment with moderate to severe fatigue) were recruited and randomly assigned to RESTORE or a leaflet. Feasibility and acceptability were measured by recruitment, attrition, intervention adherence, completion of outcome measures and process evaluation. Change in self-efficacy to manage CRF was also explored. Outcome measures were completed at baseline (T0), 6 weeks (T1) and 12 weeks (T2). Data were analysed using mixed-effects linear regression and directed content ...
BMC Medical Informatics and Decision Making, 2015
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.
JMIR cancer, 2017
Cancer-related fatigue (CrF) is the most common and disruptive symptom experienced by cancer survivors. We aimed to develop a theory-based, interactive Web-based intervention designed to facilitate self-management and enhance coping with CrF following cancer treatment. The aim of our study was to outline the rationale, decision-making processes, methods, and findings which led to the development of a Web-based intervention to be tested in a feasibility trial. This paper outlines the process and method of development of the intervention. An extensive review of the literature and qualitative research was conducted to establish a therapeutic approach for this intervention, based on theory. The psychological principles used in the development process are outlined, and we also clarify hypothesized causal mechanisms. We describe decision-making processes involved in the development of the content of the intervention, input from the target patient group and stakeholders, the design of the ...
2017
Background The number of post-treatment cancer survivors in Ireland is set to increase in coming years, due to advances in screening and treatment. This group will require ongoing supportive care as many will experience persistent negative side-effects that can impair quality of life. Cancer-related fatigue (CrF) is the most common and disruptive symptom experienced by cancer survivors. Fatigue is extremely complex, and likely to involve the interaction of several physiologic and psychological mechanisms. Current evidence supports the use of nonpharmacological treatment strategies for reducing CrF. In order to develop evidencebased psychological interventions there is a need to understand the biological, psychological, and social contributors to positive adjustment in post-treatment cancer survivors. Online interventions have been shown to be an effective mode of delivery and can facilitate selfmanagement of long-term conditions. Aim This thesis will outline the rationale, decision-making processes, methods, and findings which led to the development of an online intervention that was tested in a feasibility trial. This theory-based intervention aimed to facilitate self-management and enhance coping with fatigue following cancer treatment. Methods The studies conducted in this research were based on the development phase of the UK Medical Research Council Framework for developing complex interventions. In the first study a systematic review and meta-analysis was conducted to identify the evidence base xiii List of Appendices See Volume II of thesis submitted for the Degree of Doctor of Philosophy Contents in Volume II Appendices Appendix 1. Characteristics of studies in systematic review Appendix 2. Subgroup Analyses from Systematic Review Appendix 3. Ethical Approval for Ph.D. Research Appendix 4. Press Release for Focus Groups Nurses/ psychologist Wait list Ritterband 2012 CBTinsomnia The development of an online intervention for post-treatment cancer survivors with cancer-related fatigue: Appendices
Background: Internet interventions offer advantages that especially cancer survivors who suffer from fatigue could benefit from. Given the growing number of such patients, Internet interventions could supplement and strengthen currently available health care. Objective: This paper describes the design and analysis plan that will be used to study 2 Internet interventions aimed at reducing severe fatigue in cancer survivors: a mobile ambulant activity feedback therapy supported through a weekly e-mail by a physiotherapist and a weekly Web- and mindfulness-based cognitive therapy supported online by a psychologist. The data resulting from this trial will be used to (1) investigate the effectiveness, (2) investigate potential mediators of these interventions, and (3) explore participant characteristics that can predict the effect of these interventions. Methods: A 3-armed randomized controlled trial is proposed that compares both Internet interventions with an active control condition that solely consists of receiving psycho-educational e-mails. The intervention period is 9 weeks for all 3 conditions. Six months after baseline, participants in the control condition can choose to follow 1 of the 2 experimental Internet interventions. Outcomes are measured in terms of fatigue severity, mental health, and self-perceived work ability. All are Web-assessed at baseline, 2 weeks after the intervention period, and at 6 and 12 months after baseline. Fatigue severity, mindfulness, physical activity, expectations and credibility of the intervention, therapeutic working alliance, sleep quality, and sense of control over fatigue are assessed 3 times during the intervention period for identifying mediators of the interventions. Recruitment is performed nationally throughout the Netherlands through patient organizations and their Web sites, newspapers, and by informing various types of health professionals. All participants register at an open-access Web site. We aim at including 330 cancer survivors who have finished curative-intent cancer treatment at least 3 months previously, and have been suffering from severe fatigue ever since. All cancer types are included. A detailed analysis plan is described to address the research questions, which allows for individual variation, and fully exploits the longitudinal design. Results: Recruitment started in April 2013 and will proceed until April 2015. Conclusions: This paper describes a systematic trial design for studying 2 different interventions for chronic cancer-related fatigue in order to gain insight into the effectiveness and mediators of the interventions. This design will also be used to identify predictors for the interventions’ effect on fatigue. By publishing our hypotheses and analysis plan before completion of data collection, this paper is a first step in reporting on this trial comprehensively. Trial Registration: The Netherlands National Trial Register (NTR3483). (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).
Web-based individual Mindfulness-Based Cognitive Therapy for cancer-related fatigue — A pilot study
Internet Interventions, 2015
Background: Severe fatigue may persist for many years in cancer survivors and has a considerable impact on a patient's life. This condition is called cancer-related fatigue (CRF). Mindfulness-Based Cognitive Therapy has shown to significantly reduce CRF in cancer survivors. Internet-delivered interventions can be valuable for fatigued patients who are not able to travel to a healthcare institute because of the lack of energy and/or physical limitations. Therefore, we have developed a web-based, therapist guided individual 9-week Mindfulness-Based Cognitive Therapy (eMBCT) aimed at diminishing CRF. Objective: The aim of this study was to evaluate the efficacy of eMBCT in a clinical setting in reducing fatigue severity and distress in cancer survivors. Methods: This pilot study was based on data from severely fatigued cancer survivors who applied for eMBCT between 2009 and 2013. Our primary outcome measure was the change in self-reported web-assessed fatigue severity, measured with the Fatigue severity subscale of the Checklist Individual Strength before (baseline) and one month after (post-assessment) eMBCT. The secondary outcome was distress (HADS) and the proportion of participants that showed clinically relevant improvement on fatigue severity. Patients' satisfaction with using eMBCT and reasons for non-adherence were studied. Intention-to-treat analyses were performed using multiple imputations to deal with data loss at post-assessment. All patients had to be severely fatigued at baseline (≥35 on the fatigue severity subscale of the Checklist Individual Strength), were N 18 years old, had no history of psychosis or current Major Depressive Disorder, finished their last cancer treatment at least six months ago (mixed cancer types), and were not in the terminal phase of illness. Patients were recruited offline as well as online. Results: Two-hundred fifty-seven patients (age range 22-79 (M = 50.2, SD = 10.7), 76% women, 44% breast cancer, most had had surgery, chemo-and/or radiotherapy) met our inclusion criteria. Paired samples t-tests showed that fatigue severity was significantly reduced post-assessment (t(18) = 13.27, p b .001, Cohen's d: 1.45 as well as distress (t(46) = 7.66, p b .001, Cohen's d: 0.71). Thirty-five percent (n = 89) was clinically relevant improved at post-assessment and 62% (n = 159) adhered to treatment. This study had a completion rate of 1.5 and a registration rate of 2.3. Conclusion: These findings suggest that individual eMBCT may be effective in reducing fatigue in cancer survivors. A randomized controlled study with a large sample and longer follow up is needed to demonstrate the effectiveness of eMBCT for CRF.
BMJ Open, 2016
Introduction: Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancerrelated fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom. Objectives: This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment. Methods and analysis: This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator. Participants: 80 post-treatment cancer survivors will be recruited for the study. Interventions: An 8-week online intervention based on cognitive-behavioural therapy. Primary and secondary outcome measures: The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention. Results: The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes. Conclusions: This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF posttreatment. Setting: Recruitment from general public in Ireland. Ethics and dissemination: This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal.
BMC Nursing, 2008
Background Cancer-related fatigue (CRF) and its impact on patients' quality of life has been an increasing subject of research. However, in Germany there is a lack of evidence-based interventions consistent with the multidimensional character of fatigue. The objective of this study is to develop and evaluate a self-management program for disease-free cancer patients to cope with CRF. Methods Based on evidence extracted from a literature review, a curriculum for the self-management program was elaborated. The curriculum was reviewed and validated by an interdisciplinary expert group and the training-modules will be pretested with a small number of participants and discussed in terms of feasibility and acceptance. To determine the efficacy of the program a randomised controlled trial will be carried out: 300 patients will be recruited from oncological practices in Bremen, Germany, and will be allocated to intervention or control group. The intervention group participates in the pr...