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PhD Defence Fieke Bruggeman-Everts

evaluation of two different web-based interventions for chronic cancer-related fatigue - online mindfulness-based cognitive therapy and ambulant activity feedback

Fieke Bruggeman-Everts is a PhD student in the research group Biomedical Signals and Systems. Her supervisor is prof.dr. M.M.R. Vollebroek-Hutten from the Faculty of Electrical Engineering, Mathematics and Computer Science.

About a quarter of cancer survivors suffer from chronic cancer-related fatigue (CCRF). CCRF may persist for many years after treatment and has a considerable impact on a patient’s life because of its interference with daily activities and because it hinders patients to participate optimally into the society and work [1–7]. Fortunately, physical activity interventions and psychosocial interventions seem effective in reducing these fatigue complaints [8–12]. Moreover, eHealth allows interventions to be available at any time and place, which is especially beneficial for CCRF patients who do not have the energy to travel. Therefore, two different Web-based interventions were developed aimed at reducing CCRF: a physiotherapist-guided ambulant activity feedback (AAF) therapy encompassing the use of an accelerometer, and a psychologist guided Web-based mindfulness-based cognitive therapy (eMBCT).

To improve the quality and accessibility of Web-based interventions for cancer survivors who suffer from CCRF, this dissertation comprises the investigation of the following research questions in a 3-armed RCT:

  1. The effectiveness of two different types of Web-based interventions (AAF and eMBCT) for reducing CCRF compared to an unguided active control condition receiving psycho-educational e-mails (PE);
  2. Specific and generic predictors and working mechanisms of these interventions;
  3. Patient experiences with following these interventions.

This project is called the ‘Fitter na kanker’ trial, or FNK trial, and concerns applied research initiated by two research departments in clinical psycho-oncology practice centers: the Helen Dowling Institute (www.hdi.nl) and Roessingh Research and Development (www.rrd.nl).

Chapter 1 holds a short introduction about CCRF and Web-based interventions aimed to help reducing CCRF. In chapter 2 it was investigated whether cancer-related fatigue was significantly reduced after eMBCT intervention compared to before in a clinical setting (pre-post measurement). It was found that in 35% of the patients fatigue severity was clinically relevant improved after the intervention. In addition, results showed acceptability of this form of treatment by CCRF patients was sufficient. The findings suggested that individual eMBCT may be effective in reducing fatigue in cancer survivors, but as this help a pre-post measurement design, a randomized controlled study with a large sample and longer follow up is needed.

In chapter 3, the research protocol of a 3-armed randomized-controlled trial was presented. This trial design paper was published before analyzing the data, and is therefore in line of the Open Science movement [13], which strives to make science more transparent during the research process. Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: AAF (n=62), eMBCT (n=55), and PE (n=50). All interventions were 9 weeks. Our primary outcome measure was fatigue severity, measured with the fatigue severity subscale of the Checklist Individual Strength. Our second outcome was mental health, measured with Positive and Negative Affect Scale (PANAS) and Hospital Anxiety and Depression Scale (HADS). Fatigue severity and mental health were assessed before, during (week 3,6 and 9), and after the interventions. Also other constructs of interest such as expectations about the interventions, the level of mindfulness and sense of control over fatigue were assessed to investigate working mechanisms and predictors of fatigue severity change. Physical activity was monitored before, during and after the interventions using an accelerometer. Moreover to investigate qualitatively how these interventions attuned to the patients’ needs, we carried out semi-structured interviews.

To investigate whether, or to what extent, mindfulness skills are a working mechanism in mindfulness-based interventions, there is a need for reliable and valid tools to measure mindfulness. We chose to investigate a Dutch translation of the Freiburg Mindfulness Inventory [14] (FMI-14) as it is short and measures the aspects of mindfulness that are thought to be of great importance in medical psychology research and practice, namely Awareness and Presence. In chapter 4 we indeed found this two component structure and concluded that the Dutch FMI is an acceptable instrument to measure mindfulness in patients who experienced a life-threatening illness in a Dutch speaking population.

In chapter 5, we present the results of the effectivity of both AAF and eMBCT compared to PE between baseline and 6 months later. Using latent growth curve modeling (LGM) we visualized the course of fatigue severity over time, and found that this course of fatigue severity (thus the slope of fatigue severity change) was significantly steeper than the slope in PE. Moreover, fatigue severity substantially reduced (clinical relevant improvement) in 62% of the participants in AAF, 49% in eMBCT compared to 12% in PE. Furthermore, mental health increased in all three conditions. Reducing the intensity of eMBCT and improving usability of the accelerometer in the AAF may reduce dropout rates.

To increase our knowledge on how change in AAF and eMBCT may be established, in chapter 6 the predictive value of (1) the baseline values (predictors) and (2) the slope factors (working mechanisms) for fatigue severity change were investigated in two separate multiple group regression analyses. We found that (1) patients with high sense of control at baseline benefit from eMBCT, (2) patients with high credibility of psycho-education about CCRF benefit from PE, (3) an increase in sense of control was a generic working mechanism for fatigue severity reduction in both eMBCT and AAF, and not in PE, and (4) a decrease in fatigue catastrophizing was a specific working mechanisms in PE. Interestingly, the pre-hypothesized constructs expectancy, mindfulness (acceptance and presence), sleep quality, fear of cancer recurrence, and baseline fatigue severity had no significant predictive value for fatigue severity reduction in all three conditions, neither were they found to be working mechanisms.

And finally, in chapter 7 we report on a phenomenological study that aimed to understand CCRF patient experiences with following AAF or eMBCT. We found that CCRF is characterized by a distance between the inner world (affected body and mind due to invasive and insecure cancer treatment feelings of fatigue, pain, feeling alienated in the body) and the outer world (expectations of themselves, social environment and society about  living care free, having high energy, maintaining a job, hobbies). This distance resulted in need for reorientation of what they could and what they wanted to do in their daily life. eMBCT and AAF were helpful in a sense that patients were given useful insights in their boundaries and pitfalls, while being guided by an acknowledging, professional and caring therapist. In AAF reorientation was established by changing the outer world, by receiving feedback on physical activity that advised them when to rest and when to be physically active, thereby providing them with a new norm of what is the right behavior and what was expected. In eMBCT patients learnt to focus on their inner world, and communicating about it with their therapist. Hindering factors such as poor technology usability and mismatch in the amount and content of the exercises, and no personal match with the therapist, led to frustration and/or dropout.

In conclusion, AAF and eMBCT are effective interventions for reducing fatigue and improve mental health, as they help increasing sense of control of fatigue through providing helpful tools and being guided by a professional and caring therapist. The interventions helped patients’ reorientation of their identity as they gained insights in their boundaries and pitfalls.

In chapter 8 (discussion) we further elaborate on the results of this dissertation and we give recommendations for improvement of the interventions, and recommendations future research.