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Supporting Resilience and Case Finding

Supporting Resilience and Case Finding. Evaluation of an Innovative Procedure for Detecting Psychological Distress in Patients with Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26756
Enrollment
240
Registered
2015-04-30
Start date
2015-05-07
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

Psychological distress Cancer patients Anxiety Depression Psychologische distress Kankerpatiënten Angst Depressie

Interventions

Based on empirically derived predictors of poor resilience (‘yellow flags’), patients are divided into (I) a group with an elevated risk of experiencing psychological distress, and (II) a group with

Sponsors

VUmc-GGZ inGeest PO Box 74077, 1070 BB Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients with cancer, treated at the VU University Medical Center (VUmc), department of Medical Oncology (clinic and day treatment) • Patients are enrolled, using a proportional stratified consecutive sample based on the cancer diagnoses in the population at the department of Medical Oncology. Each stratum is represented in the sample (both in the ‘before’ and ‘after’ phase) in the same proportion as in the population at the department of Medical Oncology • Start with anti-tumor treatment • Life expectation > 3 months

Exclusion criteria

Exclusion criteria: • Age 85 years • Second opinion • Patients with head or neck cancer • Patients who are participating in the TES-trial • Insufficient command of the Dutch language • No informed consent

Design outcomes

Primary

MeasureTime frame
Primary outcome is the recognition of psychological distress after introduction of the new procedure. The diagnostic accuracy of the new procedure (study aim v-a) is determined by comparing information in the medical/nursing record about the presence of psychological distress with patient reported psychological distress (Distress Thermometer + Problem List, HADS). Sensitivity, specificity, false positives, false negatives, and positive and negative predictive value are determined.

Secondary

MeasureTime frame
- Evaluation of diagnostic accuracy of current clinical practice, which will be evaluated in an analogous way (study aim i). - A comparison of the diagnostic accuracy of phase 1 (before) and phase 2 (after) (study aim v-b). The two phases are compared in terms of sensitivity and specificity, (negative and positive) predictive values, and likelihood ratios (of positive and negative results). This is tested in terms of the diagnostic odds ratio, being a single indicator of diagnostic test performance (25). - A descriptive analysis of the level of psychological distress, patients’ subjective need for treatment, and actual treatment of psychological distress, and separately for phase 1 (before) and phase 2 (after) (study aims ii, iii, iv, vi, vii and viii). Appropriate descriptive statistics will be used. - A comparison between phase 1 (before) and phase 2 (after) of the level of psychological distress, patients’ subjective need for treatment, and actual treatment of psychological distress (study aims vi, vii and viii). Multiple regression analysis (continuous measures) or logistic regression analysis (dichotomous measures) will be used.

Contacts

Public ContactWendy Aerts

A.J. Ernststraat 1187

E-mail: w.aerts@ggzingeest.nlTel: 020-7884582

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)