Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy (QPL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoadjuvant Therapy; Shared Decision Making; Breast Cancer Early Stage Breast Cancer (Stage 1-3)
• Intervention / Treatment: Other: Question prompt list

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonios Valachis, MD, PhD; Phone Number: +46 0196021792; Email: antonios.valachis@regionorebrolan.se
• Study Contact Backup: Name: Servah Hosseini, MD

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • Recruiting
    • Örebro University Hospital
    • Contact: Antonis Valachis, MD, PhD
    • Contact: Antonios Valachis
    • Contact: Åsa Wickberg, MD, PhD
  • Region Uppsala
    • Uppsala, Region Uppsala, Sweden
      • Not yet recruiting
      • Akademiska Uppsala University Hospital
      • Contact: Henrik Lindman, MD, PhD
      • Contact: Andreas Karakatsanis, MD, PhD
  • Region Västmanland
    • Västerås, Region Västmanland, Sweden
      • Not yet recruiting
      • Västerås General Hospital
      • Contact: Cecilia Nilsson, MD, PhD
      • Contact: Staffan Eriksson, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Question prompt list; Patients will receive a question prompt list before their 1st visit to the oncologist for discussion about neoadjuvant therapy	Other: 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.
No Intervention: Usual care; Patients do not receive a question prompt list before their 1st visit to the oncologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Principal Investigator: Antonis Valachis, MD, PhD, Department of Oncology, Örebro University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; shared decision making; neoadjuvant therapy; question prompt list; patient-physician communication
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 280103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No