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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group/pre intervention | No 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. | |
| intervention arm | Experimental | another 164 patients will receive the decision aid as support for the decision making process with their clinician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Other | This will be an online tool giving evidence based information and explanation on their options. |
|
| 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 |
| 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 |
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Inclusion Criteria:
18 years or older
Female
Doubtful indication of:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud UMC | Nijmegen | Gelderland | 6525 GA | Netherlands | ||
| MAASTRO-clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32298961 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Pre- and post intervention study.
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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.
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| 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) |
| Maastricht |
| Limburg |
| 6229 ET |
| Netherlands |
| Maastricht University | Maastricht | Limburg | Netherlands |
| Academisch Medisch Centrum (AMC) | Amsterdam | North Holland | 1105 AZ | Netherlands |
| NKI-AVL | Amsterdam | North Holland | Netherlands |
| D017437 |
| Skin and Connective Tissue Diseases |