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

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ClinicalTrials.gov Identifier: NCT03375801
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Decision Aid Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 328 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Pre- and post intervention study.
Masking: None (Open Label)
Masking Description:

first 164 patients will not receive the decision aid, they will only fill out the questionnaires.

The next 164 patients will receive the decision aid and will be asked to fill out the same questionnaires.

Primary Purpose: Other
Official Title: Implementing a Decision Aid for Breast Cancer and DCIS Patients Deciding on Their Radiation Treatment: A Pre- and Post-intervention Study.
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. Decisional conflict [ Time Frame: 90 days after the decision on their radiation treatment has been made ]

    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.



Secondary Outcome Measures :
  1. Improvement on the perceived level of shared decision making. [ Time Frame: 90 days after the decision on their radiation treatment has been made ]
    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.

  2. Improvement on the perceived level of shared decision making. [ Time Frame: 90 days after the decision on their radiation treatment has been made ]
    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).

  3. Patient knowledge [ Time Frame: directly after the decision on adjuvant RT has been made (<3 days) ]
    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).

  4. Decisional conflict [ Time Frame: 365 days after the decision on adjuvant RT has been made ]

    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.


  5. Prospective process evaluation [ Time Frame: directly after the decision on adjuvant RT has been made (<3 days) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375801


Locations
Netherlands
Radboud UMC Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Daniela Raphael    020 512 2193    brasa@nki.nl   
MAASTRO-clinic Recruiting
Maastricht, Limburg, Netherlands, 6229 ET
Contact: Liesbeth Boersma, Prof. Dr.    +31-88-44 55 666    liesbeth.boersma@maastro.nl   
Principal Investigator: Liesbeth Boersma, Prof. Dr.         
Maastricht University Recruiting
Maastricht, Limburg, Netherlands
Contact: Daniela Raphael    020 512 2193    d.raphael@maastrichtuniversity.nl   
Principal Investigator: Liesbeth Boersma, Prof. Dr.         
Principal Investigator: Trudy van der Weijden, Prof. Dr.         
Principal Investigator: Nicola Russell, Dr.         
Academisch Medisch Centrum (AMC) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Daniela Raphael    020 512 2193    brasa@nki.nl   
NKI-AVL Recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: Nicola Russell, Dr.    020 512 9111    n.russell@nki.nl   
Principal Investigator: Nicola Russell         
Sponsors and Collaborators
Maastricht University

Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT03375801     History of Changes
Other Study ID Numbers: M17SDM
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases