Clinical trial NCT03375801: Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment.
Official title: Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 403
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pre- and post intervention study.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Female
* Doubtful indication of:

  * Whole breast irradiation after lumpectomy for DCIS
  * Whole breast irradiation after lumpectomy for low risk invasive BC (TOP-1 study)
  * Boost dose in case of Breast Conserving Therapy
  * Thoracic wall irradiation post mastectomy

Exclusion Criteria:

* Metastasis
* Inability to speak and read Dutch. Inability to use internet access, either in the home or at a hospital facility.

Primary outcomes:
measure: Decisional conflict
timeFrame: 90 days after the decision on their radiation treatment has been made
Secondary outcomes:
measure: Improvement on the perceived level of shared decision making.
timeFrame: 90 days after the decision on their radiation treatment has been made
measure: Improvement on the perceived level of shared decision making.
timeFrame: 90 days after the decision on their radiation treatment has been made
measure: Patient knowledge
timeFrame: directly after the decision on adjuvant RT has been made (<3 days)
measure: Decisional conflict
timeFrame: 365 days after the decision on adjuvant RT has been made
measure: Prospective process evaluation
timeFrame: directly after the decision on adjuvant RT has been made (<3 days)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud UMC
state: Gelderland
city: Maastricht
country: Netherlands
facility: MAASTRO-clinic
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: NKI-AVL
state: Noord-Holland
Study officials:
References:
citation: Raphael DB, Russell NS, Immink JM, Westhoff PG, Stenfert Kroese MC, Stam MR, van Maurik LM, van den Bongard HJGD, Maduro JH, Sattler MGA, van der Weijden T, Boersma LJ. Risk communication in a patient decision aid for radiotherapy in breast cancer: How to deal with uncertainty? Breast. 2020 Jun;51:105-113. doi: 10.1016/j.breast.2020.04.001. Epub 2020 Apr 6.