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NCT Number: NCT06777420

Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Akademiska Uppsala University Hospital, Uppsala, Region Uppsala, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Concordance rate between patient and oncologist

    Time frame: Within five days from patient visit

    Concordance rate regarding the information that was given from oncologist to the patient during the patient visit.

Secondary outcomes

  1. Level of anxiety

    Time frame: 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.

  2. Decision-making participation

    Time frame: Within five days from patient visit

    Patients' perception about their participation in decision-making process (measured by the 9-item Shared Decision Making Questionnaire)

  3. Patient-physician communication

    Time frame: 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)

  4. Decisional conflict

    Time frame: Within five days from patient visit

    Patients' experience on decisional conflict (measured by the decisional conflict scale)

Study contacts

Contact information is provided by the study sponsor or research team.

Antonios Valachis, MD, PhD

CONTACT

[email protected]

+46 0196021792

Servah Hosseini, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study 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

Acronym: QPL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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