Tired of being fatigued? Extending evidence-based treatment options for fatigued breast cancer survivors using the internet

Up to 40% of breast cancer survivors suffer from severe fatigue that impairs
daily functioning and reduces quality of life. A randomised controlled trial
(RCT) performed by our own research group showed that face-to-face cognitive
behaviour therapy (CBT) specifically designed for postcancer fatigue
significantly reduced fatigue and functional impairments in fatigued cancer
survivors [1]. The substantial positive effects were maintained at a two years
follow up [2]. Unfortunately, treatment capacity for face-to-face CBT for
postcancer fatigue in the Netherlands is limited. To meet the need for
evidence-based treatment for postcancer fatigue we will develop a web-based
intervention with minimal support from therapists and test its efficacy. If its
efficacy can be demonstrated, internet therapy will have several advantages
compared to face-to-face CBT. First, treatment capacity can be increased
because less therapist capacity is needed to deliver the intervention.
Secondly, the accessibility of the intervention can be increased. Finally, the
burden for patients is reduced, because they no longer need to travel and can
choose the moments that they want to use the intervention.
At this moment, face-to-face CBT for postcancer fatigue is offered to survivors
who finished cancer treatment at least one year previously. However, there are
indications that fatigued survivors could be offered this CBT at an earlier
stage, i.e. 3 months post-treatment [3], but this has not been tested. If CBT
is already effective at 3 months post-treatment, patients could receive
treatment earlier and do not necessarily need to suffer from postcancer fatigue
for at least one year. In the current study we will investigate if time passed
since the end of cancer treatment moderates the effects of internet therapy on
fatigue.

Increase the evidence-based treatment options by testing the efficacy of
self-guided web-based CBT for fatigued breast cancer survivors with minimal
therapist support in a randomised controlled trial.

A multicenter randomized controlled trial with two conditions, i.e. one
control condition (care as usual) and one intervention condition (internet
therapy). Two hospitals will participate in the study: Radboud University
Nijmegen Medical Centre and Ziekenhuis Gelderse Vallei at Ede. Participants
will be assessed twice, i.e. at baseline (T0), and after 6 months (T1).

Internet therapy: Fatigued breast cancer survivors will receive internet
therapy; a web-based version of the face-to-face CBT protocol for postcancer
fatigue, with self-guidance instructions. Patients will be guided through the
treatment modules with the help of assignments and instructions in a period of
6 months. They will e-mail with a therapist about their progress and
difficulties. In addition to e-mail contact, we will offer distance video
contact through FaceTalk. This e-Health application mimics a *real*
face-to-face CBT session by using a high-quality video link on a secure
connection. In the first two sessions and during the last session patients will
have face-to-face contact with their therapist. If a patient remains fatigued
after internet therapy, regular face-to-face CBT for postcancer fatigue will be
offered.
Care as usual: Participants assigned to this control condition will receive
care as usual. After the second assessment, these participants will be offered
regular face-to-face CBT for postcancer fatigue. In routine care a waiting
period exists for regular face-to-face CBT of at least six month. Therefore
participation in the study will not lead to longer waiting periods.

There are no risks involved in participating in the internet intervention.
Previous studies indicated that both face-to-face CBT and Internet CBT is a
safe treatment for patients suffering from chronic fatigue syndrome [4-6]. In
addition, the burden is limited and less than face to face CBT. It consists of
visiting the treatment centre for two assessments, 3 face-to-face sessions with
a therapist, following the CBT via the Internet and doing home-work
assignments. There are substantial potential benefits: face-to-face CBT for
cancer survivors proved to be a highly effective intervention in reducing
fatigue and disabilities and it is likely that participants of the present
study will also profit and become less fatigued and disabled.
Participants have to complete questionnaires, two times in a period of
approximately 6 months. The questionnaires can be completed at home, online, or
(upon request) a paper and pencil version will be send to the participant. It
will take patients about 45 minutes to complete the questionnaires. Completing
the questionnaires is without risk and the burden is limited.
Face-to-face CBT for postcancer fatigue is part of clinical routine at the
Expert Centre for Chronic Fatigue (ECCF). Due to limited treatment capacity
patients have to wait at least six month for this treatment. Therefore,
participation in the current study will not lead to a longer waiting period.
Allocated to the internet therapy condition patients have the opportunity to
start earlier with treatment and allocation to the usual care condition will
lead to the standard waiting period of the current clinical routine.