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

Colorectal cancer is one of the most common cancer diagnoses worldwide
affecting men and women almost equally. Population ageing and improved methods
of early detection and treatment have led to rising numbers of patients
surviving colorectal cancer. With the introduction of the national colorectal
cancer screening program in the Netherlands, the incidence is expected to even
further increase, especially for early stages. Approximately 60% of the
patients survive 5 years or more without a cancer recurrence. Although the
majority of colorectal cancer survivors (CRCS) are resilient and eventually
adjust well, a substantial minority experience high levels of distress that
affect the patients' quality of life. The prevalence estimate of psychological
distress in CRCS is about 35%.

Intervention studies for distress in CRCS are scarce. The CORRECT intervention
(COloRectal canceR distrEss reduCTion) will be aimed at decreasing
psychological distress through participatory healthcare. The context of
healthcare is rapidly changing, "patients shift from being mere passengers to
responsible drivers of their health and medical care providers encourage and
value patients as partners" (Society Participatory Medicine). Patients are
expected to assume a greater role in managing their own care. The CORRECT
intervention will stimulate participatory healthcare by combining face-to-face
cognitive behavioral therapy with self-management activities at a secured
website. This innovative approach is called blended therapy. By adding online
activities to face-to-face therapy, patients can seek treatment at home at
their convenience and spend more hours to learn new skills to manage distress.
Moments of contact with the therapist will occur at fixed time points to
support the survivor in his/her effort to self-manage distress and to
communicate about progress and difficulties. The CORRECT intervention will
stimulate and facilitate self-management by gradually decreasing therapist
support and increasing self-management towards the end of the intervention
period. In this way patients take charge of their own health and learn to cope
with the challenges of the future as cancer survivor.
There is a growing body of research demonstrating that cancer patients tend to
experience clusters of problems rather than a single problem in isolation. The
CORRECT intervention will address key elements of psychological distress in
CRCS 1) distress caused by physical consequences of colorectal cancer, e.g.
postcancer fatigue, gastrointestinal problems, urinary incontinence, sexual
dysfunction 2) anxiety and fear of recurrence, 3) depressive mood. As not all
factors might be equally relevant for each patient, the intervention will be
individually tailored to the survivors' needs.

An elaborate treatment-protocol will be written by experienced psychologists
with patient participation. The interactive self-management website will be
developed with use of the e-health application myTherapy. The content of the
website will be adapted from existing websites developed by the Department
Medical Psychology of the Radboudumc. The intervention exists of maximum 8
sessions (5 face-to-face, 3 e-consultations) with a total duration of four
months. The website will be available to support the participant throughout the
entire intervention, including psycho-education, assignments, assessments and
video clips.

A multicentre randomized controlled trial will be conducted:
1.to test the effectiveness and cost-effectiveness of the CORRECT intervention
compared to treatment as usual in decreasing distress (BSI-18)
2.to provide a more complete understanding of the usage of online activities by
exploring in what amount and how CRCS use the interactive website and how
online usage is associated with distress reduction

Assessments will take place at baseline (T1, time of inclusion). After four
months the second assessment will take place (T2). Between T1 and T2 the
CORRECT intervention will be carried out. The follow-up assessment (T3) will be
administered at 3 months after the intervention (7 months after baseline).

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 directed at change of cognitions and
behavior related to key factors of distress.
Distressed colorectal cancer survivors (CRCS) who will be randomized to the
intervention will be in different phases of their survivorship trajectory.
Therefore, distress may be the result of different problems. Also the factors
related to distress are not the same for each patient, so each treatment will
be individually-tailored based on the distress analysis in the first session
and the data gathered during baseline assessment. Three different types of
distress will be differentiated in further tailoring the intervention: 1)
distress caused by physical consequences (like post-cancer fatigue,
gastrointestinal problems, urinary incontinence and sexual dysfunction, 2)
Anxiety and fear of recurrence, 3) depressive mood

The control group has access to usual care and will not be offered the CORRECT
intervention. In recent years, the need for psychosocial screening has been
recognized, guidelines have been formulated and systematic screening has been
implemented in hospitals in the Netherlands. If distress is detected during
routine follow-up, TAU will be very diverse. Physicians or nurses may advise
patients how to reduce distress or patients will be referred to their general
practitioner or a psychologist. No restrictions will be made in the TAU
condition to use internet, psychological or other interventions

There are no risks involved for the participating patients of this study. Only
time investment is asked regarding the completion of the questionnaires and/or
CBT treatment.