Effectiveness of blended therapy for psychological distress in colorectal cancer survivors: The CORRECT multicenter trial

Completed

• Conditions: bowel cancer; 10017991; colorectal cancer; rectal cancer; 10001302

• Registration Number: NL-OMON47176
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

- Colorectal cancer survivors with curative intent (stage I, II and III)
- Completed cancer treatment at least 6 months and no more than 5 years
- Cancer-free at study entry, as defined by the absence of somatic disease activity parameters
- Distress Thermometer score equal or higher than 5 (validated cut-off score indicating high distress levels)
- Age of 18 years and older
- Sufficient understanding of the Dutch language to fill out questionnaires
- Basic Internet Skills (e.g. possession of email address, internet access at home, weekly Internet use and able to use Internet without help of others)
- Able to travel to the hospital for the CBT intervention

Exclusion Criteria

- No current therapeutic treatment or during the last month (e.g. counseling, cognitive behaviour therapy, group psychological treatment)
- Inability to provide informed consent due to intellectual disability or cognitive impairment
- Lynch Syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the study is general distress (measured with the Brief<br /><br>Symptom Inventory-18). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes are Quality of Life (measured with the EORTC-QLQ-C30 and<br /><br>QLQ-CR38), fatigue (measured with the Checklist Individual Strength), anxiety<br /><br>and depressive symptoms (measured with the Hospital Anxiety and Depression<br /><br>Scale), fear of recurrence (measured with the Cancer Worry Scale), coping<br /><br>(measured with the Impact of Event Scale) and self-efficacy (measured with the<br /><br>Self-Efficacy Scale).</p><br>