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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Decision Aid

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.

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud UMC
  • Limburg
    • Maastricht, Limburg, Netherlands
      • Maastricht University
    • Maastricht, Limburg, Netherlands, 6229 ET
      • MAASTRO-clinic
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Academisch Medisch Centrum (AMC)
    • Amsterdam, Noord-Holland, Netherlands
      • NKI-AVL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group/pre intervention; the first 164 patients will receive care as usual and will make the decision together with their clinician without support of the decision aid. They will be asked to fill out the questionnaires.
Experimental: intervention arm; another 164 patients will receive the decision aid as support for the decision making process with their clinician.	Other: Decision Aid; This will be an online tool giving evidence based information and explanation on their options.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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
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)

Collaborators and Investigators

• Sponsor: Maastricht University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): July 27, 2020

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: M17SDM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No