Breast Cancer Early Stage Breast Cancer (Stage 1-3)QPLNCT06777420
Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy
A study testing Question prompt list in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Neoadjuvant Therapy, run by Region Örebro County at 3 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Neoadjuvant Therapy, Shared Decision Making
- What is being tested?
- Question prompt list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Mar 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with operable breast cancer eligible for systemic neoadjuvant therapy, according to current treatment guidelines.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Servah Hosseini, MD contact
Sweden3 sites, 3 recruiting
- Recruiting
Örebro University Hospital
Örebro, 70185
Antonios Valachis
Antonis Valachis, MD, PhD
- Not yet recruiting
Akademiska Uppsala University Hospital
Uppsala, Region Uppsala
Andreas Karakatsanis, MD, PhD
Andreas Karakatsanis, MD, PhD
- Not yet recruiting
Västerås General Hospital
Västerås, Region Västmanland
Cecilia Nilsson, MD, PhD
Cecilia Nilsson, MD, PhD
About this study
Official 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
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.
Read more
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
- Being tested
- Question prompt list
- Keywords
- breast cancer, neoadjuvant therapy, question prompt list, patient-physician communication, shared decision making
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Question prompt listOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Question prompt list | Experimental | Patients will receive a question prompt list before their 1st visit to the oncologist for discussion about neoadjuvant therapy Receives: Other: Question prompt list |
| Usual care | No intervention | Patients do not receive a question prompt list before their 1st visit to the oncologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate between patient and oncologist
Concordance rate regarding the information that was given from oncologist to the patient during the patient visit.
Measured: Within five days from patient visit
Secondary outcomes (4)
Level of anxiety
The level of anxiety (measured by the State-Trait Anxiety Inventory) after patient visit to oncologist and before treatment initiation.
Measured: 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)
Measured: 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)
Measured: Within five days from patient visit
Decisional conflict
Patients' experience on decisional conflict (measured by the decisional conflict scale)
Measured: Within five days from patient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Mar 2025
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonis Valachis, MD, PhD, Principal investigator, Department of Oncology, Örebro University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777420
- Sponsor's protocol ID
- 280103
- Acronym
- QPL
- Status last verified
- Nov 2024
- First submitted
- 3 Jan 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06777420
- Acronym / sponsor ID
- QPL / 280103
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Question prompt list | Experimental | Other: Question prompt listPatients will receive a question prompt list before their 1st visit to the oncologist for discussion about neoadjuvant therapy |
| Usual care | No intervention | –Patients do not receive a question prompt list before their 1st visit to the oncologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with operable breast cancer eligible for systemic neoadjuvant therapy, according to current treatment guidelines.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Question prompt listThe 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. | Other | Question prompt list |
Primary outcome
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.
4 secondary outcomes
Level of anxiety
Time frame: Within five days from patient visit
Decision-making participation
Time frame: Within five days from patient visit
Patient-physician communication
Time frame: Within five days from patient visit
Decisional conflict
Time frame: Within five days from patient visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Servah Hosseini, MD contact
Antonis Valachis, MD, PhD principal investigator
Department of Oncology, Örebro University Hospital, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Question prompt list in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Neoadjuvant Therapy, run by Region Örebro County at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonios Valachis, MD, PhD (+46 0196021792, antonios.valachis@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate between patient and oncologist (time frame: Within five days from patient visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.