Tailored patient values elicitation task for rectal cancer treatment decision-making

Short-course pre-operative radiotherapy (PRT) in primary rectal cancer reduces
local recurrence rates from 11% with total mesorectal excision (TME) surgery
alone to 6% with added PRT, but strongly increases probabilities of late side
effects (faecal incontinence and sexual dysfunction), without survival benefit.
The guideline prescribes PRT, even though the decision to apply PRT is
exemplary for a preference-sensitive decision. Those involved in developing the
guideline thus felt their preference regarding the tradeoff between benefits
and side effects to be indisputable. However, clinicians have been shown to be
inaccurate in predicting patient preferences. Patients are currently not made
aware of the preference-sensitive nature of the tradeoff underlying PRT, and
their preferences are not assessed on a routine basis. This is in contrast with
findings from our research in this patient group (UL 2005-3213), in which both
oncologists and patients felt that the best achievable care is a function of
patient preference.
A values clarification exercise may aid patients to reflect on their values for
outcomes of care. Adaptive Conjoint Analysis (ACA) is an individually-tailored,
theory-based method to assess these values. In UL 2005-3213 we found the task
to be feasible and valid in treated rectal cancer patients. Both patients and
oncologists indicated the need to assess patient preferences in treatment
decision-making and felt the ACA could support this.

This research aims to assess the effect ofn completing an ACA-task on
decision-making regarding short-course pre-operative radiotherapy in the
treatment of rectal cancer in clinical practice.

This multicenter study will employ a usual care phase (N=87), followed by an
intervention phase (N=87). The intervention phase will offer patients the
ACA-task. The computerized ACA-task will be completed immediately prior to the
consultation; it will provide immediate feedback on screen, with a copy printed
out, on patients' relative preferences for five-year survival, five-year local
control, faecal incontinence, and sexual dysfunction. Patients may show the
copy to their oncologist if they wish.

The intervention group will be asked to complete the ACA-task immediately
prior to their visit to the radiation oncologist, in the waiting area of the
radiotherapy department. It is expected that time needed to complete the task
will be 15 to 20 minutes. Upon completion, a graphic summary of the relative
importance scores for the four treatment outcomes is produced and printed out
for the patient*s use.

This research pertains to a preference study. Patients will therefore not be
exposed to risks by participating. The burden to patients for participating
includes:

- reading the brochure about the study;
- receiving a phone call in which one is asked to indicate willingness or
unwillingness to participate in the study;
- fill in the two questionnaires (2 x 20 minutes in usual care phase and 3 x 20
minutes in the intervention phase);
- intervention group: fill in the ACA-task (1 x 20 minutes);
- intervention phase: patient interview (1 x 20 minutes for intervention group);
- a recording on audiotape will be made of the consultation.

Patients have the right to withdraw from participation at any time.