Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT05407168
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2021-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D006293', 'term': 'Health Promotion'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decision Conflict', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed using the Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict.'}, {'measure': "Efficacy of a conversation tool on patients' knowledge of lung cancer", 'timeFrame': 'Up 6 months', 'description': 'Will be assessed using nine questions from previously validated measures.'}, {'measure': 'Satisfaction with Communication/Confidence in Decision', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed using the 20-item COMRADE scale. Higher scores indicate better outcomes.'}, {'measure': 'Self-Efficacy', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed using the Decision Self-Efficacy Scale which contains 11 items. Higher scores indicate higher self-efficacy.'}], 'secondaryOutcomes': [{'measure': 'FACT-L', 'timeFrame': 'Up to 6 months.', 'description': 'Quality of Life will be assessed by the Functional Assessment of Cancer Therapy -- Lung scale. This scale has 27 items. Higher scores indicate higher quality of life.'}, {'measure': 'Depression/Anxiety', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed using the 4 item Patient Health Questionnaire for Anxiety and Depression scale. Scores greater than or equal to 3 on the first two questions suggest anxiety, and scores greater than or equal to 3 on the last two questions suggest depression.'}, {'measure': 'Participation in Decision-Making', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed using the 2-item Control Preferences Scale. Answers of 1 or 2 on both items are categorized as "patient controlled", answers of 3 are categorized as "shared", and answers of 4 or 5 are categorized as "physician-controlled."'}, {'measure': 'Decision Regret', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed using the 5-item Decision Regret Scale. Higher scores indicate high regret.'}, {'measure': 'Quality of Communication', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed using the \\~30 item Patient Assessment of cancer Communication Experiences scale. Higher scores indicate higher perceived quality of communication.'}, {'measure': 'Number of Palliative Care Referrals', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed by conducting chart review'}, {'measure': 'Treatment Decision-Making Concordance', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed by observing the treatment received and the treatment most aligned with responses to the conversation tool. If the treatment received is the same treatment the patient preferred according to the conversation tool, the treatment decision will be considered concordant.'}, {'measure': 'Acceptability', 'timeFrame': 'Up to 6 months', 'description': 'Will be assessed using the Ottawa Acceptability scale for patients in the intervention group only.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '40098532', 'type': 'DERIVED', 'citation': 'Disher N, Dieckmann NF, Case JR, Rubim F, Eden KB, Golden SE, Matlock DD, Coleman C, Lyons KS, Saha S, Slatore CG, Vranas KC, Sullivan DR. Improving lung cancer decision-making using a conversation tool (iDECIDE): a stepped wedge pragmatic clinical trial. Future Oncol. 2025 Apr;21(9):1045-1056. doi: 10.1080/14796694.2025.2475733. Epub 2025 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Conduct a randomized, controlled trial evaluating the efficacy of a conversation tool on patient-centered health and decision-making outcomes among patients making lung cancer treatment decisions. A subset of participants from control and intervention groups will also have their clinic conversations with providers recorded II. Conduct in-depth, semi-structured qualitative audio or video recorded interviews among a subset of Aim 1 participants.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients review decision aid.\n\nGROUP II: Patients receive standard of care.\n\nAfter completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AIM 1: Suspected lung cancer\n* AIM 1: English fluency\n* AIM 1: \\> 6-month life expectancy\n* AIM 1: Score of ≥ 3 on the cognitive impairment screener\n* AIM 2 PARTICIPANTS: Participation in Aim 1\n* AIM 2 CLINICIANS: Discussing lung cancer treatment decisions with Aim 1 participants'}, 'identificationModule': {'nctId': 'NCT05407168', 'acronym': 'iDECIDE', 'briefTitle': 'Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Improving Decision-Making Encounters in Lung Cancer (I DECide) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool', 'orgStudyIdInfo': {'id': 'STUDY00023160'}, 'secondaryIdInfos': [{'id': 'NCI-2021-09819', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00023160', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (decision aid)', 'description': 'Patients review decision aid.', 'interventionNames': ['Other: Health Promotion and Education', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (standard of care)', 'description': 'Patients receive standard of care.', 'interventionNames': ['Other: Best Practice', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive standard of care', 'armGroupLabels': ['Group II (standard of care)']}, {'name': 'Health Promotion and Education', 'type': 'OTHER', 'description': 'View decision aid', 'armGroupLabels': ['Group I (decision aid)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (decision aid)', 'Group II (standard of care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97123', 'city': 'Hillsboro', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donald Sullivan, MD, MA, MCR', 'role': 'CONTACT', 'email': 'sullivad@ohsu.edu', 'phone': '503-220-8262', 'phoneExt': '58087'}, {'name': 'Donald Sullivan, MD, MA, MCR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hillsboro Medical Center', 'geoPoint': {'lat': 45.52289, 'lon': -122.98983}}, {'zip': '97216', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donald Sullivan, MD, MA, MCR', 'role': 'CONTACT', 'email': 'sullivad@ohsu.edu', 'phone': '503-220-8262', 'phoneExt': '58087'}, {'name': 'Donald Sullivan, MD, MA, MCR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Adventist Health Portland', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donald R Sullivan, MD, MA, MCR', 'role': 'CONTACT', 'email': 'sullivad@ohsu.edu', 'phone': '503-220-8262', 'phoneExt': '58087'}, {'name': 'Donald R Sullivan, MD, MA, MCR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donald R Sullivan, MD, MA, MCR', 'role': 'CONTACT', 'email': 'sullivad@ohsu.edu', 'phone': '503-220-8262', 'phoneExt': '58087'}, {'name': 'Donald R Sullivan, MD, MA, MCR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Portland VA Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Donald R Sullivan, MD, MA, MCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Donald R Sullivan, MD, MA, MCR', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}