Cancer patients with an adjustment disorder
Background
Every year more than 110,000 patients are diagnosed with cancer in the Netherlands, and it is estimated that over 800.000 people are living with cancer. There is convincing empirical evidence that cancer patients have to deal with psychological and social 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 sequelae. In case of severe and persistent problems with adjustment to cancer, a DSM adjustment disorder can be diagnosed (Diagnostic and Statistical Manual of Mental Disorders). The prevalence of adjustment disorder among cancer patients has been estimated to be 19.4%. However, other studies reported prevalence rates of 5.8% to 16.9%. In case of an adjustment disorder a psychological intervention is needful.
Objectives
The prevalence of adjustment disorders among cancer (ex)patients has been reported to be high. Although a large amount of studies have shown evidence for the effectiveness of psychological interventions targeting cancer patients, so far, no study focused on the (cost-)effectiveness of psychological interventions targeting cancer patients with an adjustment disorder. In order to facilitate the discussion on reimbursement of psychological treatment in Dutch mental healthcare for cancer patients with an adjustment disorder, more evidence is needed. Therefore, this study aims to provide insight into the reach, the effectiveness, cost-utility and budget impact of psychological interventions targeting cancer patients with an adjustment disorder.
Method
Study design:
This study consist of two parts. Part 1 is an observational study among a representative group of cancer patients after treatment to assess the prevalence of an adjustment disorder as well as the need for psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial (RCT) to measure the effectiveness and cost-utility of the psychological intervention. Assessments will take place at baseline and at 3 and 6 months follow-up.
Study population:
Inclusion criteria are cancer survivors diagnosed with cancer (all types and stages, except non-melanoma skin cancer) before July 2018, finished primary cancer treatment with curative or palliative intent (all treatment modalities, except for endocrine therapy in breast/prostate cancer) and being aged ≥18 years. There will be no exclusion criteria. Patients of part 1 who are diagnosed with an adjustment disorder will be invited for part 2.
Intervention:
According to the national guideline “Adjustment Disorder”, the psychological intervention consists of three modules: a module for diagnosis and psycho-education (4 sessions, all patients) and two additional modules comprising of various types of psychological interventions (maximum of 6 sessions per module, tailored to the individual patient).
Sample size calculation:
To demonstrate an effect size of 5 point, 77 participants in each condition are needed in part 2 (power 80%, significance level 5%). Anticipating a drop-out rate of 25% between baseline measurement and follow-up at 6 months, 103 participants per condition will be included at baseline.
Instruments:
In part 1 the reach of the intervention will be investigated by diagnosing patients on whether or not to have an adjustment disorder in two steps:
- screening with questionnaires (distress thermometer, problem list and HADS)
- a diagnostic interview by a psychologist, psychotherapist or psychiatrist registered in the NVPO expert file, when a patient shows an increased risk on having an adjustment disorder.
In part 2 the effectiveness, cost-utility and budget impact of the tailored psychological treatment will be investigated. The primary outcome measure is psychological stress (HADS). Secondary outcome measures are quality of life (EORTC-QLQ-C30), adaptability to cancer (MAC), quality of life (EQ-5D-5L) and costs (iPCQ and iMCQ)
Collaboration
This project is a collaboration between the VU Amsterdam, UMC Radboud and the Netherlands Comprehensive Cancer Center (IKNL).
Staff
Prof. dr. I.M. Verdonck – de Leeuw, Department of Otolaryngology–Head and Neck Surgery, AmsterdamUMC, location VUmc, Amsterdam,
Prof. dr. JB Prins, Department of Medical Psychology, Radboud University Medical Center, Nijmegen
Dr. F. Jansen, Department of Clinical Psychology, VU, Amsterdam
Dr. J.A.E Custers, Department of Medical Psychology, Radboud University Medical Center, Nijmegen
F.E. van Beek MSc, Department of Clinical Psychology, VU, Amsterdam
L.M.A Wijnhoven Radbound MSc, Department of Medical Psychology, Radboud University Medical Center, Nijmegen
Publications
- van Beek FE, Wijnhoven LMA, Jansen ., Custers JAE, Aukema E, Coupé VMH, Cuijpers P, de Graaf IM, Horevoorts NJE, van der Lee ML, Lissenberg-Witte BI, van de Poll LV, Wijnen B, Prins JB, Verdonck-de Leeuw IM. The prevalence of adjustment disorder among cancer patients, and the reach, effectiveness, cost-utility and budget impact of tailored psychological treatment: study protocol of a randomized controlled trial. BMC Psychology, 2019 (in press).
Funding
ZonMw
Questions?
For questions please contact Florie van Beek MSc, junior researcher, [email protected]
and dr Femke Jansen, [email protected]