Breast Cancer Clinical Trial
Official title:
Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.
This is a pre-and post intervention study on the effect and implementation of an personalized decision aid for woman with breast cancer who face a decision on their radiation treatment.
Rationale: Guidelines on breast cancer treatment show grey areas for some radiotherapy (RT)
indications. In some recommendations the uncertainty is marked and deferred to sharing the
final decision on the treatment of choice with the patient. Other recommendations are
straightforward, but the multidisciplinary team may decide, based on the latest literature,
that different options should be discussed with the patient. In these so called "preference
sensitive decisions" there is not one best option. The best option depends on the individual
patients' preferences based on neutral and complete information tailored to her own
situation. Decision aids support clinicians as well as patients in Shared Decision Making
(SDM). Decision aids reduce the patient's decisional conflict after making their decision,
increase their knowledge on their illness and the treatment options, and their perceived
level of involvement in the decision making process. Although extensive research has been
carried out on the effect of decision aids in clinical trials, less is known of the effect of
a decision aid in daily clinical practice. The implementation of SDM is challenged by many
barriers. The investigators hypothesize that adapting the decision aid to individual patient
characteristics may enhance both personalised medicine and SDM.
Objective: To investigate whether SDM using a personalised decision aid, results in improved
outcomes of decisional quality, measured by the Decisional Conflict Scale after 3 months and
one year, and improved outcomes of the decisional process, measured with the SDMQ9 and
collaboRATE directly after the last consultation, compared to the standard clinical practices
in breast cancer patients facing a decision on their radiation treatment.
Study design: This is a multicenter clustered , pre- and post-intervention study. Before the
intervention 164 patients will be included. After introducing the decision aid, at the
beginning of the intervention period, clinicians will be trained in using the decision aid
and the other 164 patients will be recruited.
Study population: Breast cancer patients facing a decision in their adjuvant radiation
treatment.
Intervention: The intervention group will receive the instructions and the online decision
aid.
Main study parameters/endpoints: Primary endpoint: Decisional conflict 3 months after the
decision has been made. Secondary endpoint(s): The perceived level of shared decision making,
patient knowledge, , and decisional conflict 1 year after decision has been made. A process
evaluation will also be perform.
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