Aim of the study: To settle this debate, a decision aid is developed and presented to patients with metastatic disease, and its effects are assessed. The decision aid gives information on side-effects and prognosis of the treatments. We will address…
ID
Source
Brief title
Condition
- Endocrine neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of information items requested by the patient
Secondary outcome
Well-being and psychological variables related to decision making
Background summary
Background: Patients with cancer rank information about risks and prognosis
higher than other information needs. This information empoweres patients to be
involved in their treatment decisions. Decision aids are effective tools to
impart such information. Such aids are designed to help patients make specific
and deliberative choices among options by providing information about the
relevant options and outcomes. Some authors question this approach in the
non-curative setting. Participation in treatment decisions are known to decline
with increasing age and with the severity of the disease. Patients with cancer
may become emotionally unstable, and this may decrease the uptake of
information. These arguments are thought to be especially relevant for patients
with a bad prognosis, e.g., patients with metastases. In contrast, other
research on decision aids has shown that, from the patient perspective,
decision aids are beneficial without causing harm, also for patients with
cancer. In practice, clinicians may vary the amount of information based on
their judgement of the patient. Thus there is a continuing debate on the
desirability of informing patients with cancer and thereby involving them in
their own care process.
Study objective
Aim of the study: To settle this debate, a decision aid is developed and
presented to patients with metastatic disease, and its effects are assessed.
The decision aid gives information on side-effects and prognosis of the
treatments. We will address the following questions: 1a) Do these patients want
to be informed about the treatment options, and specifically about their
prognosis? 1b) Which factors determine whether or not these patients want to be
informed? 2) Can the medical oncologist judge whether or not the patient wants
the risk information? 3) What is the effect of the decision aid on patient
outcomes (well-being, information and decision related outcomes, treatment
choice) compared to usual care?
Study design
Plan of investigation:
Patients are randomised between involvement (I) or usual care (II).
I: Involvement group. Questions 1 and 2 are studied using a decision aid as an
intervention. A literature study will be undertaken to compare best supportive
care and palliative chemotherapy. The results will be used to develop the
decision aid. Patients with distant metastases or loco-regional recurrence
after primary breast or colon cancer (N=150), who face the choice between first
line palliative chemotherapy or best supportive care, are eligible and included
prospectively. After the first consultation, the oncologist will judge whether
the patient wants to be informed (question 2). In a consecutive face-to face
interview with all patients, a research nurse will deliver the decision aid
using a step-by-step procedure. Information about side-effects is given first.
Information on prognosis is offered and delivered upon request. The number of
information items desired by the patient is recorded. This, the information
acceptance, is the main outcome measure, used to answer questions 1a and 1b. At
baseline, 1 week before the interview, socio-demographic data, and
psychological predictors, believed to predict information acceptance, are
obtained by self-report questionnaires. Psychological predictors are e.g.
cancer worries, mental adjustment to cancer, information preferences, and
decision style preferences. After the interview, and two months later, we
collect data on well-being, information and decision related outcomes, and
treatment choice.
II: Usual Care group. 100 patients are approached, who will receive care as
usual. Identical self -report questionnaires will be sent at the same time
moments. By comparing the Usual Care with the Involvement group, question 3 is
answered.
Intervention
The decision aid is delivered by a research nurse immediately after the visit
with the medical oncologist, in which second line palliative chemotherapy is
offered. The decision aid explains the two treatment options chemotherapy and
best supportive care in detail, resulting in a strongly structured interview.
Patients receive a general introduction about the benefits and risks of
chemotherapy and best supportive care. The nature of all possible outcomes,
(e.g. hair loss, nausea) is discussed taking into account factors that affect
daily living.
Next, an overview of the two treatment options is presented. For each
option, numerical risk information regarding the side-effects and prognosis
(response rate, progression-free and overall survival) is available but not
necessarily provided. Risk information is given in numeric format and using
visual aids.
The risk information for both options will be given in a step-by-step
procedure, starting with the information on side-effects, and followed by
information on response chances, progression-free survival , and finally
information on survival. Risk information on the side-effects of both options
is given to all patients. After this information is provided, patients are
asked whether they considered this information desirable. Next, patients are
asked if they desire additional information on progression free survival for
both options, to be delivered in a similar format. If desired , this
information is provided. Finally this procedure is repeated for information on
overall survival for both options. Thus our primary outcome, information
acceptance, is assessed: it can range from zero to three, where zero
corresponds with no information desired, and three corresponds with information
desired for the side-effects, progression free, and overall survival. Reasons
in favour and against acceptance are collected using open interview techniques.
The provided information is also made available in a brochure, that can be
taken home. Of course, the information in the brochure is tailored to the
information desires of the patient.
Study burden and risks
All patients: 3 questionnaires of 40 minutes
Involvement-group: an interview (40 minuten) for presenting the decision aid
and collecting the primary outcome measure
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients with distant metastases or loco-regional recurrence after primary breast or colon cancer are eligible, if they face the choice between second line palliative chemotherapy or best supportive care.
Exclusion criteria
Exclusion criteria are labile personality structure, as assessed by the physicians, and a Karnofsky lower than 60.
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 |
---|---|
CCMO | NL11011.091.06 |