Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy

Официальное название

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

Обзор

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.

Вмешательства

• Другое Question 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.

Первичные конечные точки

• Concordance rate between patient and oncologist [Срок оценки: Within five days from patient visit]

Вторичные конечные точки (4)

• Level of anxiety [Срок оценки: Within five days from patient visit]
• Decision-making participation [Срок оценки: Within five days from patient visit]
• Patient-physician communication [Срок оценки: Within five days from patient visit]
• Decisional conflict [Срок оценки: Within five days from patient visit]

Критерии участия

Критерии включения

• Patients with operable breast cancer eligible for systemic neoadjuvant therapy, according to current treatment guidelines.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Швеция · 3 центра

• Akademiska Uppsala University Hospital — Uppsala
• Västerås General Hospital — Västerås
• Örebro University Hospital — Örebro

Идентификаторы

NCT: NCT06777420 · 280103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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