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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41458
Enrollment
715
Registered
2013-04-12
Start date
2013-07-30
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

gevoelens van angst en depressie Psychological distress. Anxious and depressive mood.

Interventions

We have developed the TES program, which involves Targeted selection and Enhanced care, delivered on the basis of Stepped care (TES). The steps include: (i) Watchful waiting. (ii) If psychological d
an internet based self-help program or a booklet and surface mail is used to deliver self help. (iii) If psychological distress persists, a problem analysis is performed and a contract is made with
treatment consists of problem solving therapy (face-to-face).(iv) If psychological distress persists, psychotherapy or medication is offered.

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Age 85 years; insufficient command of the Dutch language; recent psychotherapy (

Design outcomes

Primary

MeasureTime frame
Primary outcome is the difference in treatment effect over time in psychological distress, as assessed with the HADS.

Secondary

MeasureTime frame
Secondary outcomes include quality of life, patient evaluation of care, recognition and management of psychological distress, and costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)