Development and effectiveness of a webbased psycho-educational self-management intervention for breast cancer patients.

In the Netherlands approximately 10,000 patients are newly diagnosed with
breast cancer, of which 94% have curative treatment. The expected 10-year
survival is over 70% in the period 2000-2002. Despite the increased life
expectancy, women diagnosed with breast cancer often experience anxiety and
depression. After the operation and diagnosis of abnormal cells in the lymph
nodes both depression and anxiety reduce, and return to base level one year
after the operation. Although breast cancer patients show a good adaptation of
general distress after treatment, a part of the patients is at risk for
persistent distress. Several years after surgery approximately one third of the
women experience more anxiety and depression compared to peers without breast
cancer. In this group of patients the impact of the disease does not decrease
in the course of time.

The psychological distress of breast cancer patients after primary surgery
plays a central role in predicting subsequent survival. Low levels of distress,
low fatigue and low anxiety predicted longer relapse-free survival. Depending
on the professional, individual specialized psycho-oncological care appears to
have fair to good effect. It is scientifically demonstrated that psychological
interventions with cognitive behavioral therapy through E-health is equally
effective as psychological interventions with face-to-face contact, for example
in the area of anxiety, depression or emotional processing problems. At this
moment there are no comparable psychological treatments available online for
patients with breast cancer.

The purpose of this study is to develop a webbased intervention for breast
cancer patients to reduce the impact of psychological problems that arise after
the completion of medical treatment at an early stage. The question is whether
this intervention compared with usual care is effective in reducing
psychological distress.

In a randomized controlled trial (RCT), two groups will be compared. In the
experimental group usual care will be supplemented with the use of the BREATH
intervention on a protected website. The control group only uses usual care and
reflects the natural course of treatment. The latter group may freely use
information on breast cancer on the Internet, as in daily practice is possible,
but does not have access to the protected website with the BREATH intervention.
By comparing the experimental group and the control group, the effect of the
intervention will be identified. During hormonal therapy patients report mood
swings and increased fatigue, which can be expected to influence the
relationship between the intervention and the outcome variable. Therefore,
after stratification for the use of hormonal therapy a randomized block design
will be used. After stratification patients will be randomized according to a
predetermined procedure and random allocation to the two research groups will
take place.

The Internet intervention will focus on information and treatment of
psychological problems (such as anxiety and depression), emotional processing
issues, social problems (such as work resumption and reactions fo the
environment), and physical problems (such as pain, fatigue and sexuality),
which can all be influenced by psychological factors. With short-term cognitive
behavioral therapy patients are offered the opportunity to successively go
through several treatment modules for psychological, social or physical
problems. Each cognitive behavioral module contains exercises or homework to
promote behavioral change.
The intervention will be developed by the Department of Medical Psychology of
the UMC St Radboud. This department has a long experience in developing
e-health programs for medical and psychological treatment (eg IVF, young people
with diabetes, rheumatoid arthritis, psoriasis and cardiac patients).

There are no risks involved for the participating patients of this study. Only
time investment is asked regarding the completion of the questionnaires. In
addition, patients in the experiment group have access to an additional
psychoeducational website (BREATH website), in addition to standard treatment.
No condictions are attached to the use, and correspondingly, the time
investment of the intervention, this is done at the initiative of the patient.
It is up to the patient to what extent they use the website. The aim of the
research is to reduce the impact of psychological problems that arise after the
completion of medical treatment at an early stage. In the long term the
research may contribute to prevention of psychologiscal problems in breast
cancer patients.