The effectiveness and evaluation of the online 'Kanker Herstel Hulp' intervention in cancer survivors.

In the Netherlands 83.000 new cancer cases occur each year. It is estimated
that the number of patients who survive their cancer and have to live with the
aftermath will rise to almost 700.000 patients in 2015. This means that each
year large numbers of cancer patients end their treatment en try to move on
with their lives. These survivors however often experience a number of social,
psychological and physical problems, for which they receive insufficient after
care treatment. The Health Council of the Netherlands recently concluded that
current after care for cancer survivors is insufficient and doesn't meet their
needs. To provide in this need for information, help and advice, an inegrated
and tailored website will be developed, the 'Kanker Nazorg Wijzer'. The
effectiveness of this webite in improving quality of Life, reducing distress
and physical en psychosocial problems, fulfillment of informational needs and
promoting a healthy lifestyle, self-management and problem solving skills will
be studied.

The project primarily aims to study short (3 and 6 months) and long term (12
months) health related effects of the 'Kanker Nazorg Wijzer' on survivors'
psychosocial distress and quality of life (QoL). Furthermore, process aspects
of usage and evaluation of different modules of the 'Kanker Nazorg Wijzer' will
be studied.

Secondary aims are to study the effect of the use of the intervention on
disease self-management and problem solving skills, the amount of experienced
social support from important others, the extent to which a healthier lifestyle
is achieved and the extent to which the information need is fulfilled.

It is expected that the use of the 'Kanker Nazorg Wijzer' will lead to better
disease self-management and problem solving skills, a healthier lifestyle,
better fulfilled informational needs and more satisfactory support, which in
turn is expected to decrease the level of distress and improve quality of life
in cancer survivors.

The study is a randomised clinical trial (RCT). A clinical trial will be
carried out to compare the experimental group with the waiting list control
group. The cancer survivors will be randomised to one of the two conditions.

Randomisation takes place after the participants have returned the signed
informed consent form to the researchers. After returning their informed
consent, they can log in on the online research site. They then receive some
short questions to check again whether the participants meet the inclusion
criteria. Participants who do not meet the criteria will be excluded.
Participants who meet the criteria will be online randomly assigned to the
intervention condition or the control condition. To secure a balanced
allocation to the two groups with respect to some core variables like age and
gender, these variables will be taken into account. During the randomisation
process, a correction in allocation will be made when gender and age are
unevenly divided between the two groups.

After randomisation, the experimental group first fills out a baseline
questionnaire and then gets access to the online intervention, the 'Kanker
Nazorg Wijzer' for a period of 6 months. Moreover, this group has access to the
general information about the study. The control group will have access tot the
intervention after the last measurement at 12 months. During the study period,
they only have access to the part of the intervention with general information
about the study. There they are also presented the questionnaires they have to
fill in. All participants will receive (online) questionnaires: at baseline
(see the explanation above) and then at 3, 6 and 12 months after the first
measurement.

Outline of the study design:

E: O1 x O2 x O3 - O4 -
C: O1 - O2 - O3 - O4 x

Measurements:
E: Experimental group
C: Control group
O1: baseline: Quality of life (Qol), level of distress and physical and
psychosocial problems, lifestyles, self-management and problem solving skills,
information needs, before access to intervention
O2: 3 months after first measurement: Quality of life, level of distress and
physical and psychosocial problems, lifestyles, self-management and problem
solving skills, information needs. In addition, in the experimental group a
process evaluation of the intervention (usage and evaluation of modules,
process data),
O3: 6 months after first measurement: Quality of life, level of distress and
physical and psychosocial problems, lifestyles, self-management and problem
solving skills, information needs. Process evaluation of the intervention (in
the experimental group)
O4: 1 year after first measurement: Quality of life, level of distress and
physical and psychosocial problems, lifestyles, self-management and problem
solving skills, information needs.
x: access to the intervention
-: no access to the intervention

The participants in the experimental group receive access to the online
intervention for 6 months. The intervention will provide information and
tailored advice through different modules on the following subjects:

- (disease) self-management
- problem solving skills (coping)
- lifestyle behaviors
- psychological distress due to the disease
- physical complaints due to the disease (e.g. fatigue)
- handling the social environment / return to work

The modules consist among other things of written text, short videos (in which
former cancer patients tell their story) and assignements/exercises. These are
based on proven effective methodes, like cognitive behavioral therapy,
mindfulness, modelling, action planning and coping planning.

Participants in the experimental group can log in as often and as long as they
want to. Participants receive an advice to follow one or two modules, based on
the baseline questionnaire. However, participants can choose for themselves
which modules they want to follow or which information they want to read. Also,
participants can decide for themselves whether they want to follow the advice
given in the module or whether they want to do the assignments/exercises.
Participants use the programma independently, but they can always contact the
research team when needed. Medical advice will never be given. When
participants have questions regarding medical issues, they will be referred to
their own physician.

A discussion forum will probably be a part of the online programma. This
discussion forum is secured, as is the programma itself, which is not publicly
accesible. A moderator with a medical or health-psychological background will
monitor the discussion forum for the safety of the participants. However, this
person will never give personal advice and will refer participants to their own
physician when they have questions regarding their medical condition.

Participants in the waiting list control group get access to the intervention
after the last measurement at 12 months.

There are no risks and detrimental consequenses related to the study.
Participants in the experimental group can decide for themselves when and how
often they make us of the intervention. Moreover, all the participants (in the
experimental group and in the control group) can stop their participation in
the study at any time. The burden of filling out four questionnaires in a
period of 12 months is low. Moreover, expectation is that the use of the
intervention will have positive effects on the quality of life of the
participants, that it will decrease levels of distress and physical and
psychosocial problems and will contribute to a healthier lifestyle and better
self-management and problem solving skills. The participants in the control
group only complete the questionnaires during the study period. They receive
their usual health care. They won't be refrained from care (including extra
professional care they would like to seek). The participants in the control
group will receive access to the intervention (the online programme) after the
end of the study period.