A patient education program is effective in reducing cancer-related fatigue: A multi-centre randomised two-group waiting-list controlled intervention trial
Introduction
Cancer-related fatigue (CRF) is defined as a distressing persistent sense of tiredness or exhaustion related to cancer that is not proportional to recent activity and interferes with usual functioning (National Comprehensive Cancer Network, 2011). CRF is seen as a multidimensional symptom as it encompasses physical, mental and emotional aspects (Glaus et al., 1996). CRF is highly prevalent across the cancer continuum from diagnosis and treatment through survivorship and end of life. The prevalence of cancer-related fatigue ranged from 4% to 91%, depending on the population studied and the methods of assessment (Lawrence et al., 2004). Advances in diagnosis and treatment of malignancies have resulted in a growth of the number of cancer survivors. Thus, clinicians are being faced with a growing number of patients with CRF, even years after treatment.
There is a wide range of treatment options for CRF which can be classified into pharmacologic and nonpharmacologic interventions. Drug therapy for CRF is not well established yet. Hemopoietic growth factors have been suggested to treat CRF but can no longer be recommended due to safety issues (Minton et al., 2010). There is evidence for the use of psychostimulants to treat CRF (Minton et al., 2011). However, large scale trials to confirm these results are required.
Nonpharmacologic interventions focus on exercise and psychosocial interventions. In a meta-analysis, these interventions achieved an overall effect size of −0.341 (p < 0.001) (Kangas et al., 2008), with negative indices indicating less fatigue post-intervention. Exercise has been studied extensively, yielding an effect size in survivors of 0.31 (Brown et al., 2011). Psychosocial interventions may comprise psychoeducation, psychotherapy or social support; in a meta-analysis the pooled effect size was −0.313 (Kangas et al., 2008), whereas single trials resulted in effect sizes from 0.17 to 1.07 (Goedendorp et al., 2009).
Psychoeducation is common in psychosocial interventions and is recommended as a key strategy in CRF management (National Comprehensive Cancer Network, 2011). However, the efficacy of psychoeducational interventions in cancer survivors has not been established. Therefore, a patient education program was developed by multidisciplinary collaboration using formative evaluation methods. The program is named FIBS, “Fatigue individuell bewältigen – ein Selbstmanagementprogramm für Krebspatienten” (Coping with fatigue individually – a self-management program for cancer patients). In this study, the aim was to determine whether FIBS could improve the patients' CRF management.
Section snippets
Methods
A multi-centre randomised two-group waiting-list controlled intervention trial was carried out. Our main hypothesis was: Participation in the patient education program significantly changes the level of CRF in disease-free cancer survivors with a follow-up period of 6 months. The study was approved by the Ethics Committee of the University of Bremen.
Results
327 patients were assessed for eligibility; 261 were randomised, 129 allocated to the IG and 132 to the CG. 120 patients attended the program. All of these and 114 patients in the CG were analysed at follow-up. 27 patients couldn't be analysed as there were no data available (Fig. 1). No patient discontinued the intervention, but some didn't attend all modules for different reasons (e.g. illness or scheduling conflicts). The mean participation rate was 4.3 modules (n = 104).
Table 3 displays the
Discussion and conclusion
This trial, designed and reported to meet CONSORT requirements (Schulz et al., 2010), introduces an education program for fatigued cancer patients following therapy completion. In the evaluation, the newly developed program FIBS proved superior to standard information and care for patients on a wait-list. At baseline, participating patients were suffering from severe symptom burden, and the majority of patients had already made multiple attempts to combat fatigue.
Practice implications
The program FIBS has aroused considerable interest by cancer patients in Germany, since there is currently no other treatment available. The results show that FIBS has the potential to fill this gap. As the program was implemented for both sexes, for adults at a wide range of ages, many cancer entities, and at levels of fatigue from mild to severe, the results indicate that the entire range of fatigued cancer survivors may benefit from FIBS. Therefore, FIBS is supposed to be a complementary
Ethical approval
The study has been approved by the ethics committee of the University of Bremen (Germany).
Funding
The study was funded from 2007 to 2010 by the German Federal Ministry of Education and Research (FKZ: 01GT0605). The sponsor was not involved in decisions about the study design; the collection, analysis and interpretation of data; the writing of the report; or in the decision to submit the paper for publication.
Competing interests
The authors KR, UdV, FP, and SG declare no conflict of interest. The authors disclose no financial and personal relationships with other people or organisations that could inappropriately influence (bias) our work.
Study protocol
The study protocol has been published (Stuhldreher et al., 2008).
Registration
The trial was registered with ClinicalTrials.gov (Identifier: NCT00552552).
Statement
I confirm all patient/personal identifiers have been removed or disguised so the patient/person(s) described are not identifiable and cannot be identified through the details of the story.
Acknowledgements
The authors would like to thank the members of the “Bremer Krebsgesellschaft e.V.” for their practical support in realizing the initial idea and implementing the program. We would like to thank all other participating centres as well: Brandenburgische Krebsgesellschaft, Bayerische Krebsgesellschaft, Universitätsklinikum Jena, Universitätsklinikum Greifswald, Klinik für Tumorbiologie in Freiburg, Klinikum Hanau, Klinikum Region Hannover, Krankenhaus Ludmillenstift in Meppen, Praxis Phoenix in
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