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

R

Region Örebro County

Status

Enrolling

Conditions

Shared Decision Making
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Neoadjuvant Therapy

Treatments

Other: Question prompt list

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

218 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

218 participants in 2 patient groups

Question prompt list
Experimental group
Description:
Patients will receive a question prompt list before their 1st visit to the oncologist for discussion about neoadjuvant therapy
Treatment:
Other: Question prompt list
Usual care
No Intervention group
Description:
Patients do not receive a question prompt list before their 1st visit to the oncologist

Trial contacts and locations

3

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Central trial contact

Antonios Valachis, MD, PhD; Servah Hosseini, MD

Data sourced from clinicaltrials.gov

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