Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT06777420
Status:
RECRUITING
Last Update Posted:
2025-04-20
First Post:
2025-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance rate between patient and oncologist', 'timeFrame': 'Within five days from patient visit', 'description': 'Concordance rate regarding the information that was given from oncologist to the patient during the patient visit.'}], 'secondaryOutcomes': [{'measure': 'Level of anxiety', 'timeFrame': 'Within five days from patient visit', 'description': 'The level of anxiety (measured by the State-Trait Anxiety Inventory) after patient visit to oncologist and before treatment initiation.'}, {'measure': 'Decision-making participation', 'timeFrame': 'Within five days from patient visit', 'description': "Patients' perception about their participation in decision-making process (measured by the 9-item Shared Decision Making Questionnaire)"}, {'measure': 'Patient-physician communication', 'timeFrame': 'Within five days from patient visit', 'description': "Patients' experience on patient-physician communication (measured by the Patient Satisfaction Questionnaire and the Perceived Efficacy in Patient-Physician Interactions)"}, {'measure': 'Decisional conflict', 'timeFrame': 'Within five days from patient visit', 'description': "Patients' experience on decisional conflict (measured by the decisional conflict scale)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'neoadjuvant therapy', 'question prompt list', 'patient-physician communication', 'shared decision making'], 'conditions': ['Breast Cancer Early Stage Breast Cancer (Stage 1-3)', 'Neoadjuvant Therapy', 'Shared Decision Making']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nIn 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with operable breast cancer eligible for systemic neoadjuvant therapy, according to current treatment guidelines.\n\nExclusion Criteria:\n\n* Patients with locally advanced breast cancer where neoadjuvant therapy is mandatory rather than a treatment option.\n* Patients with cognitive impairment that are assessed from treating physician as unable to participate.\n* Patients who cannot speak/read neither Swedish nor English.'}, 'identificationModule': {'nctId': 'NCT06777420', 'acronym': 'QPL', 'briefTitle': 'Question Prompt List in Breast Cancer Patients Planned for Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '280103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Question prompt list', 'description': 'Patients will receive a question prompt list before their 1st visit to the oncologist for discussion about neoadjuvant therapy', 'interventionNames': ['Other: Question prompt list']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Patients do not receive a question prompt list before their 1st visit to the oncologist'}], 'interventions': [{'name': 'Question prompt list', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Question prompt list']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'state': 'Region Uppsala', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Andreas Karakatsanis, MD, PhD', 'role': 'CONTACT'}, {'name': 'Andreas Karakatsanis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Henrik Lindman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Akademiska Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Västerås', 'state': 'Region Västmanland', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Cecilia Nilsson, MD, PhD', 'role': 'CONTACT'}, {'name': 'Cecilia Nilsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Staffan Eriksson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Västerås General Hospital', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}, {'zip': '70185', 'city': 'Örebro', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Antonios Valachis', 'role': 'CONTACT'}, {'name': 'Antonis Valachis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Åsa Wickberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'centralContacts': [{'name': 'Antonios Valachis, MD, PhD', 'role': 'CONTACT', 'email': 'antonios.valachis@regionorebrolan.se', 'phone': '+46 0196021792'}, {'name': 'Servah Hosseini, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Antonis Valachis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Oncology, Örebro University Hospital, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Örebro County', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}