|- candidate number||14997|
|- NTR Number||NTR4034|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jun-2013|
|- Secondary IDs||VU 2011-5279 NL39619.029.12|
|- Public Title||Screening and treatment of psychological distress in colorectal cancer with metastasized disease: the TES-trial|
|- Scientific Title||Screening and treatment of psychological distress in colorectal cancer with metastasized disease: the TES-trial|
|- hypothesis||We hypothesize that the TES program is a cost-effective approach towards the screening and treatment of psychological distress in CRC patients with metastasized disease, in comparison to usual care.|
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer, Anxiety, Depression|
|- Inclusion criteria||- Patients with metastatic colorectal cancer (CRC);|
- Start of treatment with 1st line chemotherapy;
- Life expectation > 3 months.
|- Exclusion criteria||-Age < 18 or >85 years;|
-Insufficient command of the Dutch language;
-Recent psychotherapy (< 3 months ago);
- Contra-indication for the stepped care approach (e.g. need for immediate hospitalization in mental health institute);
- No informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||25-jun-2013|
|- planned closingdate||1-jul-2016|
|- Target number of participants||804|
|- Interventions||Targeted selection of patients with psychological distress. Enhanced care
by the clinical nurse specialist. Stepped care: The steps include: (i) Watchful waiting. (ii) If psychological distress persists, the guided self-help program. (iii) If psychological distress persists, a problem analysis is performed and an agreement is made with the patient on the next step; treatment consists of problem solving therapy (face-to-face). (iv) If psychological distress persists, psychotherapy, medication or a referral for other services (e.g. social work) is offered.
The TES intervention is compared to usual care.
|- Primary outcome||Psychological distress:|
- Hospital Anxiety and Depression Scale (HADS)
|- Secondary outcome||Quality of life:|
Patient evaluation of care:
- Client Satisfaction Questionnaire - 8
- Recognition of psychological distress by clinician.
- Referrals related to psychological distress.
Process of care:
- A questionnaire is used to collect data on process of care
- All relevant costs will be measured prospectively.
|- Timepoints||Assessments are made at the 1st cycle of chemotherapy (T0), after 3 weeks (T3), 10 weeks (T10), 24 weeks (T24) and 48 weeks (T48).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. Joost Dekker|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Joost Dekker|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Alpe d’HuZes Foundation, KWF Kankerbestrijding|
|- Brief summary||Background|
Psychological distress, i.e an anxious or depressive mood occurs frequently in patients with metastasized colorectal cancer (CRC). Psychological distress is an unfavorable outcome in itself and is frequently overlooked. To improve detection of psychological distress, the use of screening instruments has been advocated; for example, the Dutch oncology guideline “Detecting the need for psychological care” advises to screen regularly for psychological distress.
However, recent reviews have shown that it cannot be assumed that the implementation of screening and treatment leads to improvement in detection, management or outcome of psychological distress.
We have developed the TES program, which involves Targeted selection (screening at 0, 10 and 18 weeks) and Enhanced care, delivered on the basis of Stepped care (from watchful waiting to psychotherapy). The primary study aim is to evaluate the effectiveness of the TES-program compared to usual care in reducing psychological distress (as assessed with the Hospital Anxiety and Depression Scale) in metastasized CRC patients.
The study is designed as a cluster randomized trial with 2 treatment arms in 10 hospitals. The treatment arms are: TES program for screening and treatment of psychological distress versus usual care. Outcomes are evaluated at the 1st cycle of chemotherapy (T0), after 3 weeks (T3), 10 weeks (T10), 24 weeks (T24) and 48 weeks (T48).
• Patients with metastatic colorectal cancer (CRC)
• Start of treatment with 1st line chemotherapy
• Life expectation > 3 months
|- Main changes (audit trail)|
|- RECORD||17-jun-2013 - 20-aug-2013|