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Preoperative chemotherapy has been shown to be at least as effective as postoperative chemotherapy in breast cancer patients and has seen increased use over time. The decision regarding neoadjuvant treatment is complex, as various aspects need to be considered, and the patient's role in the decision-making process is central.
The information provided by doctors to patients about preoperative treatment can be complicated, including details about treatment options, treatment plans, and side effects. If this information is not conveyed adequately, there is a risk of misunderstandings, which can lead to increased anxiety and stress for patients regarding their decisions.
In oncology, question prompt lists (QPL) have been used as a tool to support patients by improving the information conveyed by doctors in various contexts where complex decisions need to be made. Studies have shown that QPL can facilitate better information exchange. However, their use in discussions about preoperative treatment for breast cancer patients has not been studied. Furthermore, evidence from randomized studies on the use of QPL in clinical practice is very limited.
The aim of this study is to investigate whether the use of QPL during patient consultations involving discussions about neoadjuvant chemotherapy can improve information exchange in various aspects: understanding of the treatment; anxiety about the decision; participation in the decision-making process; patient-doctor communication; and decision-related conflict.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Question prompt list | Experimental | Patients will receive a question prompt list before their 1st visit to the oncologist for discussion about neoadjuvant therapy |
|
| Usual care | No Intervention | Patients do not receive a question prompt list before their 1st visit to the oncologist |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Question prompt list | Other | The question prompt list includes 12 questions related to neoadjuvant therapy. It has been developed by an expert team including breast surgeons, oncologists, nurses, and psychologists and has been refined through focus interview with patient advocates and caregivers. |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance rate between patient and oncologist | Concordance rate regarding the information that was given from oncologist to the patient during the patient visit. | Within five days from patient visit |
| Measure | Description | Time Frame |
|---|---|---|
| Level of anxiety | The level of anxiety (measured by the State-Trait Anxiety Inventory) after patient visit to oncologist and before treatment initiation. | Within five days from patient visit |
| Decision-making participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonios Valachis, MD, PhD | Contact | +46 0196021792 | antonios.valachis@regionorebrolan.se | |
| Servah Hosseini, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Antonis Valachis, MD, PhD | Department of Oncology, Örebro University Hospital, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akademiska Uppsala University Hospital | Not yet recruiting | Uppsala | Region Uppsala | Sweden |
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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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|
Patients' perception about their participation in decision-making process (measured by the 9-item Shared Decision Making Questionnaire)
| Within five days from patient visit |
| Patient-physician communication | Patients' experience on patient-physician communication (measured by the Patient Satisfaction Questionnaire and the Perceived Efficacy in Patient-Physician Interactions) | Within five days from patient visit |
| Decisional conflict | Patients' experience on decisional conflict (measured by the decisional conflict scale) | Within five days from patient visit |
| Västerås General Hospital | Not yet recruiting | Västerås | Region Västmanland | Sweden |
|
| Örebro University Hospital | Recruiting | Örebro | 70185 | Sweden |
|
| D017437 |
| Skin and Connective Tissue Diseases |