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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47176
Enrollment
160
Registered
2016-01-11
Start date
2016-11-12
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

bowel cancer colorectal cancer rectal cancer

Interventions

The intervention is based on cognitive behavior therapy (CBT) and consists of blended therapy, a combination of face-to-face CBT with a self-management interactive website. The CBT protocol is direc

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is general distress (measured with the Brief Symptom Inventory-18).

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)