The development, implementation and evaluation of a Psychosocial Intervention for patients treated for NeuroEndocrine Tumors: the PINET study

Background:
Pituitary adenomas can cause classical syndromes and result in considerable
consequences for the daily lives of affected patients. Recently, studies of our
department evaluated that patients treated for pituitary adenomas report an
impaired quality of life, a higher prevalence of psychopathology and
maladaptive personality traits. Furthermore, they report illness perceptions
and coping strategies that may be characterized as inadequate.
The term psychosocial intervention and the term self-management intervention
are often used interchangeably. A considerable number of studies stated the
effectiveness of a self-management approach in chronic somatic conditions. It
can be hypothesized that a psychosocial intervention can stimulate these
patients to adapt these factors, which in turn will improve Quality of Life.
Models which are frequently used in psychosocial interventions are the *Social
Cognitive Theory* (SCT) and the *Common Sense Model of self-regulation* (CSM).

Purpose:
The main focus of our study is the development, implementation and evaluation
of a self-management intervention for patients treated for pituitary adenomas
and patients with endocrine diseases in general.

Design:
The development of the selfmanagement intervention will be doen accordign to
the focus groups and needs assessment questionnaire. Needs which come up for
discussion during the focus groups and data of the needs assessment
questionnaire will be used for the design and content of the program.
The effectiveness and practical implications of this intervention will be
evaluated in a randomized, controlled trial (RCT).

The proposed psychosocial intervention will be based on the *Patient Education
Program* (PEP); a behavioural intervention addressing psychosocial topics.
Previous research demonstrated that this program beneficially affect QoL in
patients with Parkinson*s disease and their caregivers. This structured program
consist of eight weekly sessions of ninety minutes duration, which include
seven different themes (Information, Self evaluation, Health promotion, Stress
management, Dealing with anxiety and depression, Social competence, Social
support); during the last session, the intervention will be evaluated. The
partners/caregivers of the patients are also involved in the PEP. The
participating caregivers in our study will follow the same program, but
separately from the patients. Knowledge and skills are being taught in order to
improve self-management skills, which supposedly translates into improvements
in quality of life, complementing the medical treatment. The method used in the
PEP is based on principles of cognitive-behavioral therapy. Interventions such
as systematic relaxation training, cognitive restructuring, situational
behavioral analysis, and training in social skills are included.

We presume patients are willing to participate and therefore experience this
program as not aggravating. Before and after the intervention, patients are
asked to complete questionnaires. In addition they are asked to fill out these
questionnaires after 6 months and 1 year. Completing the questionnaires will
take about 1,5 hours. Filling out these questionnaires can be aggravating to
same degree.
Participation in this study can improve quality of life. In the worst case
quality of life will stay the same. Therefore, no risks are associated to this
study.