Investigating two home-based interventions for people suffering from chronic fatigue after cancer.

About a quarter of cancer survivors suffer from severe chronic fatigue. Chronic fatigue 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. Physical activity interventions and psychosocial interventions, specifically designed to reduce fatigue, seem effective in reducing fatigue. However, there is a considerable number of severely fatigued cancer survivors who do not have access to these specific interventions. Delivering interventions through the internet enables treatment at home and as such makes interventions available for patients who do not have the time or energy to travel. This study aims at investigating the efficacy of two home-based interventions, an Ambulant personalized Activity Feedback intervention (AAF) and an online Mindfulness-Based Cognitive Therapy (MBCT) in reducing Chronic Cancer-Related Fatigue compared to a control group. In addition, we will study how these interventions work and what type of intervention is best for whom. More specifically we will test if these interventions reduce fatigue by treatment specific mechanisms as increasing activity and balancing activities during the day and increasing mindfulness and sleep quality or by more generic mechanisms as working alliance and client’s expectation about the effect of the intervention.

We hypothesize that fatigue will significantly be reduced in participants in both intervention groups, compared to participants in the minimal control intervention. We expect that this decrease in fatigue is correlated with an increase in wellbeing. In addition, we hypothesize that both intervention groups will show a significant increase in work ability, thus 1) more people will return to work, 2) on average, working hours per week is increased, and 3) on average, self-perceived ability to work is increased. The AAF is expected to have effect through increasing and the enhancement of balance in physical activity. MBCT is expected to have effects through an increase in the level of mindfulness. Both interventions are expected to have effect through non-specific variables as alliance and the expectation by the client that the intervention offered to him is suitable for reducing fatigue. In addition the outcome of both interventions may be mediated by a better sleep quality.

Patients will fill out questionnaires at the start of the intervention (T0), three-months later (T1), and after three months of follow up (T2). After T2, patients in the control condition will be offered one of the interventions at random. The intervention groups will be followed for another 6 months (T3; follow-up).

AAF (Ambulant Activity Feedback):

Patient will receive a tri-axial accelerometer (a mtx-w sensor) and a Personal Digital Assistant (PDA). The PDA displays the patient's activity and the goal activity. Patients will wear these devices during their everyday live, for a maximum of 14 hours each day (8.00 till 22.00 o’clock). The intervention consists of a monitoring and a feedback period. During the monitoring part, patients will be monitored for seven days in their own environment to establish a baseline daily activity pattern (week 0). No feedback will be given to the patient during this period. During the feedback period, patients are instructed to use the PDA for regulation of their daily physical activities. Together with their personal physiotherapist the patient will agree on a individually tailored goal value. This goal value will help the patient to balance the physical activity pattern, as more balance in the activity pattern over the day is expected to decrease the level of fatigue. In addition, patients report about their experience to their personal physiotherapist by e-mail weekly and will receive e-mail feedback on a predetermined day of the week.



Online MBCT:

Mindfulness Based Cognitive Therapy (MBCT) adds elements of cognitive therapy to the Mindfulness Based Stress Reduction (MBSR) program that was developed by John Kabat-Zinn. In contrast to Cognitive Behavioural Therapy (CBT), MBCT does not emphasize changing the content or specific meaning of negative automatic thoughts. It simply attempts to teach the participant to use a detached perspective as a skill to prevent the escalation of automatic negative thinking patterns. MBCT also teaches patients how to accept physical limitations, pain, or fatigue. The MBCT online intervention follows the same protocol and uses the same reader and homework assignments as the face-to-face MBCT protocol (van der Lee and Garssen, 2010), based on the original protocol designed by Segal et al (2001) for relapse of depression. Patients start the intervention by studying the reader for that first week and downloading an MP3 file with mindfulness exercises, which they are asked to practice every day. The reader holds information and instructions about a particular theme each week and psycho-educational information about cancer and fatigue and how mindfulness can help reduce CCRF. They register their experience with the exercise in their homework logs during the week and the therapist delivers a reaction to the logs on a predetermined day of the week. Exploration of experiences with the mindfulness exercises is essential in MBCT, therefore therapists will relate their feedback to the maintenance of fatigue. Weekly, for nine weeks, a new reader will appear on the website with new MP3 mindfulness exercises. Patients cannot continue with a next session before they have registered their experience with homework assignment of the previous week. All patients will be guided by two therapists, both having more than 5 years of experience with MBCT in cancer patients.



Minimal intervention control condition:

Patients that are assigned to the control condition, thus the minimal intervention condition, will receive weekly supportive e-mail containing standard texts with psycho-education and information about CCRF. Participants cannot reply to these e-mails in order to keep this intervention minimal and standard. This design was copied from the online alcohol addiction intervention study from Marloes Postel. In this trial the minimal intervention led to a minimal dropout rate of 15% in the control condition.