Screening and treatment of psychological distress in colorectal cancer with metastasized disease: the TES-trial

Phase 3

Completed

• Conditions: gevoelens van angst en depressie; Psychological distress. Anxious and depressive mood.; 10017991

• Registration Number: NL-OMON41458
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 715

Inclusion Criteria

Patients with metastatic colorectal cancer (CRC); start of treatment with 1st line chemotherapy according to standard care, including fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin; life expectation > 3 months.

Exclusion Criteria

Age < 18 or > 85 years; insufficient command of the Dutch language; recent psychotherapy (< 3 months ago, once every 2 weeks); severe psychopathology; no informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the difference in treatment effect over time in<br /><br>psychological distress, as assessed with the HADS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include quality of life, patient evaluation of care,<br /><br>recognition and management of psychological distress, and costs.</p><br>