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| Name | Class |
|---|---|
| Danish Breast Cancer Cooperative Group | OTHER |
| University of Southern Denmark | OTHER |
| Danish Comprehensive Cancer Center | OTHER |
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The aim of this project is to elucidate whether the use of shared decision making will influence patient engagement in the decision making process about adjuvant radiotherapy after breast conserving surgery for local breast cancer or early stages of local breast cancer.
The risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (RT). On the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. Considering the well-known side effects of irradiation, it seems appropriate to involve patients in the decision on whether to receive irradiation.
In the shared decision making (SDM) process clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences. A patient decision aid (PtDA) is instrumental in the SDM process.
This study is a multicenter, national trial randomizing doctors to either use or not use SDM and a PtDA when informing the patients about benefits and risks of receiving adjuvant radiotherapy.
It is not expected that significantly less patients will receive radiotherapy as a consequence of SDM. The primary aim of the study is to evaluate whether patient engagement in decision making is affected by SDM and the use of an in-consultation PtDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Shared decision making | Experimental | Patients will be informed by a doctor randomized to practice shared decision making and use the in-consultation PtDA during the consultation on adjuvant radiotherapy. |
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| Arm B: Usual practice | No Intervention | Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared decision making supported by an in-consultation patient decision aid | Behavioral | After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant engagement in the decision making process as measured by the Shared Decision Making Questionnaire 9. | Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement. | Within one week after the consultation |
| Measure | Description | Time Frame |
|---|---|---|
| The doctor's perception of patient engagement in the decision making process as measured by the Shared Decision Making Questionnaire doctor 9 | Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement. | Within one week after the consultation |
| The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karina D Steffensen, Professor | Vejle Hospital | Study Chair |
| Stine R Sondergaard, M.D. | Vejle Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Hospital | Aalborg | Denmark | ||||
| Aarhus University Hospital |
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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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Half the doctors at each center will receive training in SDM. These doctors will practice SDM supported by the in-consultation PtDA during every consultation in this study. The other half of the doctors will continue usual practice of informing the patients.
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Minimum value: 0. Maximum value: 36. The higher the value the more fear of recurrence. |
| Within one week after the consultation and again after six months |
| The participant's engagement in the decision making process as measured by the Shared Decision Making Process 4 questionnaire | Minimum score: 0. Maximum score: 4. The higher the score the more patient engagement. | Within one week after the consultation |
| The participant's effectiveness in decision making as measured by the Decisional Conflict Scale questionnaire | Minimum value: 0. Maximum value: 100. The higher the value the more effective decision making. | Before (12 items) and within one week after the consultation (all 16 items) |
| The participant's regret of the treatment decision as measured by the Decision Regret Scale questionnaire | Minimum value: 0. Maximum value: 100. The higher the value the more regret. | Six months after the consultation |
| The participant's engagement in the decision making process as measured by the CollaboRATE questionnaire | Minimum score: 0. Maximum score: 9. The higher the value the more patient engagement. | Within one week after the consultation |
| The participant's quality of life as measured by the EORCT QLQ-C30 (version 3.0) questionnaire, only question 29 + 30 | Minimum value: 0. Maximum value: 100. The higher the value the more quality of life. | Six months |
| Aarhus |
| Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Herlev University Hospital | Herlev | Denmark |
| Sjaellands University Hospital | Næstved | Denmark |
| Odense University Hospital | Odense | Denmark |
| Vejle Hospital | Vejle | Denmark |
| D017437 |
| Skin and Connective Tissue Diseases |