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

Psychological distress occurs in approximately one third of colorectal cancer
patients. In patients with metastasized diseased, the level of distress is even
higher. Because of the improved life expectancy, providing treatment for
psychological distress in CRC is an increasingly important issue.
Psychological distress 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.

Essential requirements for the implementation of a screening program include
(i) a valid screening instrument, and (ii) effective treatment for
psychological distress. These requirements are generally fulfilled, as several
valid screening instruments and effective treatments are available. The third
essential requirement is (iii) evidence on the (cost)effectiveness of the
actual implementation of the screening program. Unfortunately, this third
essential requirement is not fulfilled. Despite its intuitive appeal, the true
benefit of screening and subsequent treatment of psychological distress is far
from being definitively proven. In fact, the recommendation of the Dutch
guideline *Detecting the need for psychological care* to screen regularly for
psychological distress is based on consensus among professionals and one
qualitative study in oncology patients. Ideally, screening results in improved
detection, management (e.g. counselling by the clinician; or referral to a
nurse or mental health specialist) and outcome of psychological distress Recent
reviews have shown that it cannot be assumed that implementing screening and
treatment automatically leads to improvement in detection, management or
outcome of psychological distress.

Reviews indicate that effective management of psychological distress seems to
require targeted selection of patients and enhanced care. Targeted selection of
patients involves administering and scoring of the screening instrument by
someone other than the clinician; those with high scores are offered a referral
for treatment. Enhanced care involves training of clinicians and support staff,
participation of support staff, and several follow up contacts with the
patient. Targeted selection and enhanced care require substantial investments
in staff as well as clearly defined responsibilities of staff members. In
attempting to control the costs of delivering psychological interventions, the
stepped care approach has been strongly advocated as being potentially
cost-effective. In this approach, less intensive interventions are tried first
(e.g. a self help program), with more intensive and costly interventions
reserved for those insufficiently helped by the initial intervention (e.g.
face-to-face counseling).

We have developed the TES program, which involves Targeted selection and
Enhanced care, delivered on the basis of Stepped care (TES). The primary study
aim is to evaluate the effectiveness of the TES-program compared to usual care
in reducing psychological distress in metastasized CRC patients. Secondary aims
include the evaluation of the impact of the TES-program on quality of life,
patient evaluation of care, recognition and management of psychological
distress, and to evaluate the cost-effectiveness of the TES-program.

The study is designed as a cluster randomized trial with 2 treatment arms in 16
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). These measurement points coincide with the transitions in
stepped care in the experimental group.

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 distress persists, the guided
self-help program (based on problem solving therapy) is offered to the patient;
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 the patient on the next step;
treatment consists of problem solving therapy (face-to-face).(iv) If
psychological distress persists, psychotherapy or medication is offered.

The additional risk of participation in the TES trial is negligible. All
instruments, procedures and treatmens used in the assessment are being used in
care as usual: the added value of the TES intervention is in the highly
structured approach in using these instruments (*targeted selection*). The same
applies to the four steps of the intervention: watchful waiting; internet based
self-help program (based on problem solving therapy); problem solving therapy
(face-to-face); psychotherapy, medication or a referral for other services
(e.g. social work). All steps are available in care as usual: the added value
of the TES intervention is the highly structured approach in administering
these interventions.

It will take patients ~60 minutes to complete questionnaires, per assessment.
Questionnaires are completed at home.