No registrations found.
ID
Source
Brief title
Health condition
colorectal cancer, distress, anxiety, depression, colorectaal kanker, angst, depressie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psychological distress:
- Hospital Anxiety and Depression Scale (HADS)
Secondary outcome
Quality of life:
- EORTC-QLQ-C30
- RAND-36
- EuroQol-5D
Patient evaluation of care:
- Client Satisfaction Questionnaire - 8
Recognition:
- Recognition of psychological distress by clinician.
Referral:
- Referrals related to psychological distress.
Process of care:
- A questionnaire is used to collect data on process of care
Costs
- All relevant costs will be measured prospectively.
Background 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.
Objective
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.
Methods
Study design
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).
Study population
• Patients with metastatic colorectal cancer (CRC)
• Start of treatment with 1st line chemotherapy
• Life expectation > 3 months
Study objective
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.
Study design
Assessments are made at the 1st cycle of chemotherapy (T0), after 3 weeks (T3), 10 weeks (T10), 24 weeks (T24) and 48 weeks (T48).
Intervention
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.
Joost Dekker
Amsterdam 1007 MB
The Netherlands
+31.20.44.40.763.
j.dekker@vumc.nl
Joost Dekker
Amsterdam 1007 MB
The Netherlands
+31.20.44.40.763.
j.dekker@vumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3866 |
| NTR-old | NTR4034 |
| Other | NL39619.029.12 : VU 2011-5279 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |