(Cost-) effectiveness of online self-help training for fear of cancer recurrence in breast cancer patients.

The prevalence of patients living with breast cancer in the Netherlands has
been estimated to rise to 140.000 in 2020. One third of all women who have had
breast cancer suffer from fear of recurrence, which has a profound negative
impact on their quality of life. This fear may also lead to higher healthcare
costs and may compromise health outcomes. Breast cancer patients have indicated
that they lack support in dealing with their fear of cancer recurrence. In
light of the increasing prevalence of breast cancer and increasing health care
costs, we are in urgent need of a form of support that is both easily
accessible to a large group of patients and is cost-effective. Recently, an
online self-help training for fear of cancer recurrence was developed.

The primary objective of this project is to study the (cost-)effectiveness of
an online self-help training for fear of cancer recurrence. Online self-help
for FCR is not expected to be effective for all participants. It is important
to identify factors that predict whether a person does or does not benefit from
treatment. This will be the second objective of this project.

Research questions
1. Is online self-help for fear of cancer recurrence (cost-) effective?
2. Can we predict for whom online self-help is beneficial?

The design of the study will be a multi-center, randomized-controlled trial,
comparing online self-help training with care as usual. Primary outcome measure
will be fear of cancer recurrence. Secondary outcome will be healthcare costs
and distress. Patients will be randomized to either the online self-help or
care as usual. Patients will be recruited through hospitals in various regions
in the Netherlands. Assessments will take place at baseline (T0), and 3 (T1), 9
(T2), 15 (T3) and 24 months later (T4).

Participants start the training by filling out the Fear of Recurrence
Inventory, after which they get feedback about their scores and a suggestion
about which modules to follow.

The two basic modules concern:
1. Psycho-education about FCR, its symptoms and learning to recognize symptoms
of fear.
2. Teaching the basic principles of cognitive behavior therapy.

After these basic modules women can choose from the following 4 modules:
1. How to stop rumination, behavioral techniques to stop ruminating.
2. Action, making an action plan about what one can do when fear of recurrence
pops up.
3. Relax, audio files with relaxation practices.
4. Reassurance, how and when to seek reassurance.

Each module consists of an informative part and a practical part in which
participants are motivated to do exercises or assignments in daily life.
Participants are advised to take a week for each module they follow, so most
participants will need four to six weeks depending on how many modules they
follow. It is explained that the more time they invest, the more effect they
can expect from the training, but participants eventually choose themselves how
much time is actually spent on the training.

This study involves capacitated adults and therapeutic research. Participation
is free of charge. The pilot study indicates that no concrete risks are related
to the intervention. Participating in this study can be time consuming, as
participants will fill out several questionnaires at different time points.
These questionnaires contain questions that might be confronting for the
participant, as they confront the participant with her current situation.
Though, we do not expect this to be harmful.