No registrations found.
ID
Source
Brief title
Health condition
Adjustment disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is psychological distress measured by the Hospital Anxiety and Depression Scale (HADS)
Secondary outcome
Secondary outcomes of this study are mental adjustment to cancer as measured using the Mental Adjustment to Cancer Scale (MAC)) and health-related quality of life, as measured using the EORTC QLQ-C30. In addition, the cost-utility of the tailored psychological intervention will be investigated. To investigate the cost-utility, all patients will be asked to complete the EQ-5D, iMCQ and iPCQ at all measurement time points.
Background summary
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 this study, therefore, a psychological intervention tailored to the individual needs and wishes of the patient will be investigated.
Study objective
It is hypothesized that this tailored intervention is effective in cancer patients with an adjustment disorder compared to a waitlist control group, and potentially cost-saving.
Study design
Patient reported outcome measures will be assessed at baseline (before randomization), and 3 and 6 months after randomization.
Intervention
According to the national guideline “Adjustment Disorder”, the psychological intervention consists of three modules: a module for diagnosis and psycho-education (4 sessions, for all patients) and two additional modules comprising of various types of psychological interventions (maximum of 6 sessions per module, tailored to the individual patient). The three modules are provided as a continuum. After each module there will be assessed if a following module is needed.
Patients in the control group are allowed to receive care-as-usual and receive the tailored psychological intervention after a waitlist period of 6 months.
Inclusion criteria
Patients are eligible to participate if
1) age ≥ 18 years (no upper age limit)
2) diagnosed with cancer (all types and stages and stages, except non-melanoma skin cancer)
3) patients after the end of primary cancer treatment with curative or palliative intent (all treatment modalities, except for endocrine therapy in breast/prostate cancer)
4) presence of an adjustment disorder as diagnosed with a diagnostic interview
Exclusion criteria
patients who are not able to complete a Dutch questionnaire and Patients with an adjustment disorder who are already receiving psychological treatment.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7763 |
| Other | METc VUmc : 2019.002 |