Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy

NCT06777420 | Recruiting

• 1 other identifier: 280103
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Level of anxiety

  Within five days from patient visit

• Decision-making participation

  Within five days from patient visit

• Patient-physician communication

  Within five days from patient visit

• Decisional conflict

  Within five days from patient visit

Study Arms (2)

Question prompt list

EXPERIMENTAL

Patients will receive a question prompt list before their 1st visit to the oncologist for discussion about neoadjuvant therapy

Other: Question prompt list

Usual care

NO INTERVENTION

Patients do not receive a question prompt list before their 1st visit to the oncologist

Interventions

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.

Question prompt list

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (3)

Akademiska Uppsala University Hospital

Uppsala, Region Uppsala, Sweden

NOT YET RECRUITING

Västerås General Hospital

Västerås, Region Västmanland, Sweden

NOT YET RECRUITING

Örebro University Hospital

Örebro, 70185, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Antonis Valachis, MD, PhD

  Department of Oncology, Örebro University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonios Valachis, MD, PhD

CONTACT

+46 0196021792; antonios.valachis@regionorebrolan.se

Servah Hosseini, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 15, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 20, 2025

Record last verified: 2024-11

Locations

SE (3)