Breast Cancer Early Stage Breast Cancer (Stage 1-3), Neoadjuvant Therapy, Shared Decision Making
Conditions
Keywords
breast cancer, neoadjuvant therapy, question prompt list, patient-physician communication, shared decision making
Brief summary
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.
Interventions
OTHERQuestion prompt list
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.
Sponsors
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with operable breast cancer eligible for systemic neoadjuvant therapy, according to current treatment guidelines.
Exclusion criteria
* Patients with locally advanced breast cancer where neoadjuvant therapy is mandatory rather than a treatment option. * Patients with cognitive impairment that are assessed from treating physician as unable to participate. * Patients who cannot speak/read neither Swedish nor English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance rate between patient and oncologist | Within five days from patient visit | Concordance rate regarding the information that was given from oncologist to the patient during the patient visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of anxiety | Within five days from patient visit | The level of anxiety (measured by the State-Trait Anxiety Inventory) after patient visit to oncologist and before treatment initiation. |
| Decision-making participation | Within five days from patient visit | Patients' perception about their participation in decision-making process (measured by the 9-item Shared Decision Making Questionnaire) |
| Patient-physician communication | Within five days from patient visit | Patients' experience on patient-physician communication (measured by the Patient Satisfaction Questionnaire and the Perceived Efficacy in Patient-Physician Interactions) |
| Decisional conflict | Within five days from patient visit | Patients' experience on decisional conflict (measured by the decisional conflict scale) |
Countries
Sweden
Contacts
Primary ContactAntonios Valachis, MD, PhD
Backup ContactServah Hosseini, MD
Outcome results
None listed