An interventional study of Shared decision making supported by an in-consultation patient decision aid in Shared Decision Making, Breast Neoplasms and Radiotherapy, Adjuvant, sponsored by Vejle Hospital. Completed at 7 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Vejle Hospital · Not applicable, Interventional, and Supportive care
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.
12,828 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.
This study's enrollment of 678 is above the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Vejle Hospital is the lead sponsor of 95 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Shared decision making supported by an in-consultation patient decision aid
Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice.
After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.
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.
Time frame: Within one week after the consultation
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.
Time frame: Within one week after the consultation
The participant's fear of cancer recurrence as measured by the Fear of Cancer Recurrence Short form Questionnaire
Minimum value: 0. Maximum value: 36. The higher the value the more fear of recurrence.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Six months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Vejle Hospital