Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment.

Breast Cancer Clinical Trial

— BRASA  

Official title:

Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375801
• Other study ID #: M17SDM
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 27, 2020

Study information

• Verified date: July 2020
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: July 27, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Decision Aid
This will be an online tool giving evidence based information and explanation on their options.

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam	Noord-Holland
Netherlands	NKI-AVL	Amsterdam	Noord-Holland
Netherlands	Maastricht University	Maastricht	Limburg
Netherlands	MAASTRO-clinic	Maastricht	Limburg
Netherlands	Radboud UMC	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	measured with on the decisional conflict scale. Measured by the decisional conflict scale ( O'Connor, 1995), This contains 16 questions answered on a 5 point likert scale( strongly agree-strongly disagree). Items are given a score value of 0-4. The total score is calculated by: summed, divided by 16 and multiplied by 25. scores range from 0 ( no decisional conflict to 100 (extreme high decisional conflict).; The scale also consist of 5 subscales: uncertainty subscore, informed subscore, values subscore, support subscore and the effective decision subscore.	90 days after the decision on their radiation treatment has been made
Secondary	Improvement on the perceived level of shared decision making.	measured with the 9-item Shared Decision Making questionnaire (SDM-Q-9,( Kriston 2009)). This contains 9 questions answered on a 6 point likert scale, ranging from 0 ( completely disagree) to 5 ( completely agree). The total score is calculated by: summed score multiplied by 2.2222 transforming to a scale from 0 to 100.	90 days after the decision on their radiation treatment has been made
Secondary	Improvement on the perceived level of shared decision making.	measured with the collaboRATE questionnaire ( Barr 2014), This contains 3 questions answered on a 10 point anchored scale, ranging from 0 ( no effort was made) to 9 ( every effort was made). The total score is calculated by: summed score multiplied by 3.704 transforming to a scale from 0 ( no effort made) to 100 (every effort made).	90 days after the decision on their radiation treatment has been made
Secondary	Patient knowledge	measured with a ( self developed) knowledge test. This contains 11 questions with 3 possible answers ( True, not true and don't know). For every right answered question 1 point, wrong answers -1 and don't know 0 are given resulting in a range from -11 ( all answers wrong) to 11 ( all answers right).	directly after the decision on adjuvant RT has been made (<3 days)
Secondary	Decisional conflict	measured with on the decisional conflict scale Measured by the decisional conflict scale ( O'Connor, 1995), This contains 16 questions answered on a 5 point likert scale( strongly agree-strongly disagree). Items are given a score value of 0-4. The total score is calculated by: summed, divided by 16 and multiplied by 25. scores range from 0 ( no decisional conflict to 100 (extreme high decisional conflict).; The scale also consist of 5 subscales: uncertainty subscore, informed subscore, values subscore, support subscore and the effective decision subscore.	365 days after the decision on adjuvant RT has been made
Secondary	Prospective process evaluation	how many patients did effectively use the decision aid and how many consultations were needed for the decision to be made. Measured by a log system on the decision aid and by consulting the patients on how many consultations they hade before making the decision.	directly after the decision on adjuvant RT has been made (<3 days)