ADJUSTment Disorder in Cancer Patients: Effectiveness and Cost-Utility of Tailored Psychological Treatment

Every year more than 100,000 patients are diagnosed with cancer in the
Netherlands. There is convincing empirical evidence that cancer patients have
to deal with a wide range of physical symptoms and psychological, social and
existential sequelae related to cancer and its treatment, both during treatment
and at (long-term) follow-up. Psychological problems involve symptoms related
to anxiety and depression, but also problems with adjustment to cancer and its
sequela. In case of severe problems, a disorder classified according the
Diagnostic and Statistical Manual of Mental Disorders (DSM) is often diagnosed,
such as an anxiety disorder, mood disorder or adjustment disorder. In a recent
large study in Germany (n=2,141) of Mehnert et al. (2014) in a population of
mixed cancer patients who were on average 13.5 months after cancer diagnosis, a
4-week prevalence of adjustment disorder of 11.1% was shown (independently of
other mental disorders).
However, accessibility to psychological interventions for cancer patients is
limited, since treatment for patients with an adjustment disorder is since 2012
no longer reimbursed as part of Dutch mental health treatment (in Dutch:
Geneeskundige GGZ) This lack of reimbursement is unfavourable for patients with
an adjustment disorder who are at the end of follow-up care, since the
necessary psychological intervention is at this time-point no longer reimbursed
as part of the medical specialist care (DOT). In order to facilitate the
discussion on reimbursement of psychological treatment in Dutch mental
healthcare for cancer patients with an adjustment disorder, more information is
needed. No study specifically focused on the (cost-)effectiveness of
psychological interventions in cancer patients with an adjustment disorder so
far. In this proposed project, we will provide insight into theeffectiveness,
cost-utility and budget impact of psychological interventions for cancer
patients with an adjustment disorder after primary treatment, using a
randomized controlled setting.

The ultimate aim of this project is to provide scientific evidence on tailored
psychological interventions for cancer patients with an adjustment disorder.
This study investigated the effectiveness, cost-utility and budget impact of a
tailored psychological intervention on psychological distress in cancer
patients with an adjustment disorder by means of a randomized controlled trial.

Cancer patients with an adjustment disorder will be asked to participate in a
prospective randomized controlled trial with two parallel groups (1:1), with
measures before randomization (T0), and 3 (T1) and 6 months (T2) after
randomization. After providing informed consent and completion of the baseline
questionnaire, patients will be randomized into either the intervention group
or the waitlist control group. Patients randomized to the intervention group
receive a tailored psychological intervention. Patients randomized to the
waitlist control group receive the tailored psychological intervention after a
waitlist period of 6 months. During the waitlist period it is allowed to
receive usual care. A waitlist period of 6 months was deemed acceptable as in
usual care waitlists are also common. Also, a large part of the study
population currently does not receive psychological treatment for their
adjustment disorder, and a waitlist period of 6 months is therefore deemed more
acceptable than no psychological treatment at all.

The psychological intervention investigated in this proposed project follows
the guideline on diagnosis of adjustment disorders and consists of 3 modules,
namely module 1 encompassing a maximum of 4 sessions with a psychologist,
psychotherapist or psychiatrist (registered in the NVPO database) for diagnosis
and psycho-education purposes, and module 2 and 3 encompassing both 6 sessions
comprising of various types of psychological interventions. The 3 modules are
provided as a continuum. The offered psychological intervention will be
tailored to the individual needs and wishes of the patient (tailored
treatment). When possible, a short psychological treatment (module 1) of
maximal 4 sessions will be provided. The longer treatments (module 1-2 or
module 1-3) will be offered if the short psychological treatment is
insufficiently effective. After the last session of a module the patient will
be screened for symptoms of anxiety and depression using the HADS (following
the guideline on diagnosis of adjustment disorders). In case the module is
insufficiently effective, the patient is offered the next module. The type of
treatment offered in module 2 and 3 is tailored to the wishes and needs of the
patient and can consist of all (online) interventions outlined in the guideline
on adjustment disorders, such as cognitive behavioural therapy, mindfulness,
group interventions, or pharmacotherapy.

Risks are negligible. The psychological treatment is tailored to the individual
patient and follows the guideline on diagnosis of adjustment disorders in
cancer patients.