Tailored psychological treatment for cancer patients with an adjustment disorder

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23120

Enrollment

206

Registered

2019-05-27

Start date

2019-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjustment disorder

Interventions

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

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The primary outcome of this study is psychological distress measured by the Hospital Anxiety and Depression Scale (HADS)	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactI.M. Verdonck - de Leeuw

i.m.de.leeuw@vu.nl+31 20 59 86113

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)