Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
Study NCT ID:
NCT04375566
Status:
UNKNOWN
Last Update Posted:
2021-08-25
First Post:
2020-05-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Progressive Web App About Individualized Patient Decision Aid for NSCLC Stage I-II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability of PDA', 'timeFrame': '1 year', 'description': 'Opinion of the respondents about patient decision aid'}, {'measure': 'The accuracy of the information in the tool', 'timeFrame': '1 year', 'description': 'Testing the information provided in the tool and the usability of the tool itself'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iPDA', 'Shared decision making', 'Patient decision aids', 'Progressive web app'], 'conditions': ['Lung Cancer Stage I', 'Lung Cancer Stage II']}, 'descriptionModule': {'briefSummary': 'Studies indicate that the majority of early-stage non-small cell lung cancer (NSCLC) patients find it important to be involved in treatment decision making. However, in a recent study it has been reported that about 40% of the participants experienced decision conflict and feel uninformed(1). The investigators therefore developed a patient decision aid (PDA) for stage I-II NSCLC patients, that informs and empowers patients to help decide between stereotactic radiotherapy (SBRT) and surgery.', 'detailedDescription': 'A pilot study in which semi-structured interviews will be conducted (Qualitative research).In addition, patients will be asked to fill in a questionnaire about the usability of the prototype. A small group of patients (n=15) that have been treated for early stage NSCLC in the past will be asked to participate. The persons involved in this pilot are asked to assess a patient decision tool and will be interviewed only once. After the interview they will be asked to fill in a questionnaire. The burden of the pilot study is very low. No medical examinations or procedures will be carried out. Pilot study in lung cancer patients treated in the past with radiotherapy or surgery. The participants will all give informed consent. The investigators are using a qualitative design. Semi-structured interviews will be carried out. In addition the investigators will ask the participants to fill in a questionnaire with 35 questions.\n\nNo age limits are defined. The pilot study will be carried out in stage I-II NSCLC patients who were treated with radiotherapy or surgery, at least 6 months ago. Patients should currently be free of disease, no disease progression. The semi-structured interview consists of 17 open questions and text recorded, in order to be able to analyze the date afterwards. The interviews will take place when the patients come to the hospital for a regular follow-up appointment. After the interview, the patient is asked to fill in a questionnaire about the usability of the decision aid. In total, the expected duration is about 2 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Included early stage lung cancer patients and doctors. 10-20 doctors 15 patients More than 20 IT specialists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEarly stage non-small cell lung patients, Treated with curative intent minimum 6 month ago, max 5 years. Doctors IT\n\nExclusion Criteria:\n\nOthers'}, 'identificationModule': {'nctId': 'NCT04375566', 'briefTitle': 'Progressive Web App About Individualized Patient Decision Aid for NSCLC Stage I-II', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'Improving Decision Making by Developing and Testing a Progressive Web App About Patient Decision Aid for Stage I-II Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'UM_iPDA_PM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IT specialist', 'description': '20 IT Specialist will evaluate the usability and patient-friendliness of the tool', 'interventionNames': ['Other: Patient Decision Aid']}, {'label': 'Doctors', 'description': '13 doctors will evaluate the information in the tool', 'interventionNames': ['Other: Patient Decision Aid']}, {'label': 'Patients', 'description': '10-20 patients will evaluate the utility and the contribution of the tool in decision making proces.', 'interventionNames': ['Other: Patient Decision Aid']}], 'interventions': [{'name': 'Patient Decision Aid', 'type': 'OTHER', 'description': 'More than 20 IT specialists, 15 doctors and 15 patients', 'armGroupLabels': ['Doctors', 'IT specialist', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Iva Halilaj', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}