Clinical trial NCT06777420: Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy
Official title: Question Prompt List as a Tool to Promote Patient-physician Concordance in the Understanding of Information on Neoadjuvant Treatment in Breast Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Neoadjuvant Therapy
Shared Decision Making
Keywords: breast cancer
neoadjuvant therapy
question prompt list
patient-physician communication
shared decision making
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Concordance rate between patient and oncologist
timeFrame: Within five days from patient visit
Secondary outcomes:
measure: Level of anxiety
timeFrame: Within five days from patient visit
measure: Decision-making participation
timeFrame: Within five days from patient visit
measure: Patient-physician communication
timeFrame: Within five days from patient visit
measure: Decisional conflict
timeFrame: Within five days from patient visit
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska Uppsala University Hospital
state: Region Uppsala
city: Västerås
country: Sweden
facility: Västerås General Hospital
state: Region Västmanland
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Department of Oncology, Örebro University Hospital, Sweden
name: Antonis Valachis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: