Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-01-02 @ 9:57 PM
Study NCT ID:
NCT05061095
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2021-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Understanding What Matters Most to Patients: Establishing the Validity of a Best-Worst Scaling Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'daniel_richardson@med.unc.edu', 'phone': '(919) 966-4432', 'title': 'Dr. Daniel Richardson', 'organization': 'Lineberger Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Not available. The protocol does not require adverse event assessment.', 'description': 'The protocol does not require adverse event assessment. Adverse Event data was not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Participants who consented to participate and started to study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Content Validity of Best-Worst Scaling (BWS) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Qualitative Interviews', 'description': 'Participants (subset of the entire cohort) who completed cognitive interviews to establish the content validity of the BWS survey.'}], 'classes': [{'title': 'Participants who were able to accurately define each attribute and reported no missing domains.', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Participants who could not define attributes or reported missing domains.', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after treatment decision', 'description': 'Cognitive interviewing will be used to evaluate the content validity of using a BWS survey to quantify the preferences of older patients with hematologic malignancies at the point-of-care. BWS survey asks patients a series of questions where they choose one attribute as best and one as worst - the 7 included in this survey are maintaining usual activities, living longer, avoiding dependence on others, avoiding short-term side effects, avoiding long-term side effects, avoiding hospitalizations, and avoiding high out-of-pocket costs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with newly-diagnosed hematologic malignancies who completed cognitive interviews.'}, {'type': 'SECONDARY', 'title': 'Acceptability of Best-Worst Scaling (BWS) Survey to Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pilot Testing: Participants With Newly-diagnosed Hematologic Malignancies', 'description': 'Participants diagnosed participating in the questionnaire portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days after treatment decision', 'description': 'Number of patients who respond with agree/strongly agree to "I found survey acceptable to clarify my preferences"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with newly-diagnosed hematologic malignancies who completed Best-Worst Scaling (BWS) survey.'}, {'type': 'SECONDARY', 'title': 'Preliminary Efficiency of Best-Worst Scaling (BWS) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pilot Testing:', 'description': 'Participants with newly-diagnosed hematologic malignancies who participated in the questionnaire portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days after treatment decision', 'description': 'Number of patients who respond moderately effective/very affective to "how effective was the survey to help you and your doctor choose a treatment that was consistent with your goals?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with newly-diagnosed hematologic malignancies who completed survey.'}, {'type': 'SECONDARY', 'title': 'Completion Rate Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who consented to participate.'}], 'classes': [{'title': 'consented', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'started BWS instrument at baseline', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'completed BWS instrument at baseline', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'completed study-associated surveys after their treatment encounter at least 1 time', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'completed study-associated surveys after their treatment encounter more than 1 time (median 8 times)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'description': 'The completion rate over time will be reported by the number of patients who complete the BWS survey at each time point, in 3 months intervals.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects signed the consent form'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants who consented to participate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'Enrolled and Registered', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}]}], 'recruitmentDetails': 'Participants were recruited from 03/21/2022 through 06/29/2023 at one cancer center, in North Carolina. Subjects were enrolled in the study between 03/31/2022 through 06/29/2023.', 'preAssignmentDetails': 'A total of fifty-one participants consented and were eligible for the study, but twenty-seven of them started the study interventions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants who consented to participate.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '61', 'upperLimit': '91'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary diagnosis', 'classes': [{'title': 'Leukemia', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Lymphoma', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Multiple Myeloma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Blastic Plasmacytoid Dendritic Cell Neoplasm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-01', 'size': 685844, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-18T14:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2021-08-27', 'resultsFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Content Validity of Best-Worst Scaling (BWS) Survey', 'timeFrame': '3 months after treatment decision', 'description': 'Cognitive interviewing will be used to evaluate the content validity of using a BWS survey to quantify the preferences of older patients with hematologic malignancies at the point-of-care. BWS survey asks patients a series of questions where they choose one attribute as best and one as worst - the 7 included in this survey are maintaining usual activities, living longer, avoiding dependence on others, avoiding short-term side effects, avoiding long-term side effects, avoiding hospitalizations, and avoiding high out-of-pocket costs.'}], 'secondaryOutcomes': [{'measure': 'Acceptability of Best-Worst Scaling (BWS) Survey to Patients', 'timeFrame': 'Up to 7 days after treatment decision', 'description': 'Number of patients who respond with agree/strongly agree to "I found survey acceptable to clarify my preferences"'}, {'measure': 'Preliminary Efficiency of Best-Worst Scaling (BWS) Survey', 'timeFrame': 'Up to 7 days after treatment decision', 'description': 'Number of patients who respond moderately effective/very affective to "how effective was the survey to help you and your doctor choose a treatment that was consistent with your goals?"'}, {'measure': 'Completion Rate Over Time', 'timeFrame': 'Up to 1 year', 'description': 'The completion rate over time will be reported by the number of patients who complete the BWS survey at each time point, in 3 months intervals.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['leukemia', 'lymphoma', 'myeloma', 'myelodysplastic syndrome', 'best-worst scaling survey'], 'conditions': ['Hematologic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '32132149', 'type': 'BACKGROUND', 'citation': "Richardson DR, Crossnohere NL, Seo J, Estey E, O'Donoghue B, Smith BD, Bridges JFP. Age at Diagnosis and Patient Preferences for Treatment Outcomes in AML: A Discrete Choice Experiment to Explore Meaningful Benefits. Cancer Epidemiol Biomarkers Prev. 2020 May;29(5):942-948. doi: 10.1158/1055-9965.EPI-19-1277. Epub 2020 Mar 4."}, {'pmid': '33544421', 'type': 'BACKGROUND', 'citation': "Richardson DR, Oakes AH, Crossnohere NL, Rathsmill G, Reinhart C, O'Donoghue B, Bridges JFP. Prioritizing the worries of AML patients: Quantifying patient experience using best-worst scaling. Psychooncology. 2021 Jul;30(7):1104-1111. doi: 10.1002/pon.5652. Epub 2021 Feb 27."}, {'pmid': '29565196', 'type': 'BACKGROUND', 'citation': "Seo J, Smith BD, Estey E, Voyard E, O' Donoghue B, Bridges JFP. Developing an instrument to assess patient preferences for benefits and risks of treating acute myeloid leukemia to promote patient-focused drug development. Curr Med Res Opin. 2018 Dec;34(12):2031-2039. doi: 10.1080/03007995.2018.1456414. Epub 2018 Apr 27."}, {'pmid': '29731612', 'type': 'BACKGROUND', 'citation': "Bridges JF, Oakes AH, Reinhart CA, Voyard E, O'Donoghue B. Developing and piloting an instrument to prioritize the worries of patients with acute myeloid leukemia. Patient Prefer Adherence. 2018 Apr 27;12:647-655. doi: 10.2147/PPA.S151752. eCollection 2018."}, {'pmid': '27862591', 'type': 'BACKGROUND', 'citation': 'LeBlanc TW, Fish LJ, Bloom CT, El-Jawahri A, Davis DM, Locke SC, Steinhauser KE, Pollak KI. Patient experiences of acute myeloid leukemia: A qualitative study about diagnosis, illness understanding, and treatment decision-making. Psychooncology. 2017 Dec;26(12):2063-2068. doi: 10.1002/pon.4309. Epub 2016 Dec 19.'}, {'pmid': '33040623', 'type': 'BACKGROUND', 'citation': "Loh KP, Abdallah M, Kadambi S, Wells M, Kumar AJ, Mendler JH, Liesveld JL, Wittink M, O'Dwyer K, Becker MW, McHugh C, Stock W, Majhail NS, Wildes TM, Duberstein P, Mohile SG, Klepin HD. Treatment decision-making in acute myeloid leukemia: a qualitative study of older adults and community oncologists. Leuk Lymphoma. 2021 Feb;62(2):387-398. doi: 10.1080/10428194.2020.1832662. Epub 2020 Oct 11."}, {'pmid': '28264148', 'type': 'BACKGROUND', 'citation': 'Rood JAJ, Nauta IH, Witte BI, Stam F, van Zuuren FJ, Manenschijn A, Huijgens PC, Verdonck-de Leeuw IM, Zweegman S. Shared decision-making and providing information among newly diagnosed patients with hematological malignancies and their informal caregivers: Not "one-size-fits-all". Psychooncology. 2017 Dec;26(12):2040-2047. doi: 10.1002/pon.4414. Epub 2017 Apr 17.'}, {'pmid': '30139841', 'type': 'BACKGROUND', 'citation': 'El-Jawahri A, Nelson-Lowe M, VanDusen H, Traeger L, Abel GA, Greer JA, Fathi A, Steensma DP, LeBlanc TW, Li Z, DeAngelo D, Wadleigh M, Hobbs G, Foster J, Brunner A, Amrein P, Stone RM, Temel JS. Patient-Clinician Discordance in Perceptions of Treatment Risks and Benefits in Older Patients with Acute Myeloid Leukemia. Oncologist. 2019 Feb;24(2):247-254. doi: 10.1634/theoncologist.2018-0317. Epub 2018 Aug 23.'}]}, 'descriptionModule': {'briefSummary': "This study will evaluate the validity of using a survey to quantify patient preferences at the point-of-care and the potential effectiveness of the survey to improve goal-concordant care. The primary hypothesis is that by identifying the strength of patient preferences for outcomes with this survey clinicians will be able to improve goal-concordant care by aligning clinical recommendations with patients' preferences. This study will have 50 patients with newly diagnosed hematologic malignancy complete the survey throughout their disease course (up to 2 years) and conduct qualitative interviews with a subset (n = 20) of participants. The information obtained from these participants will be used to refine the survey. Interviews with oncologists and palliative care specialists (up to 10) will inform implementation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are older (≥60) patients with newly-diagnosed hematological malignancies.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed new diagnosis of one of the following hematologic malignancies: aggressive lymphoma, multiple myeloma, CLL, CML, AML, ALL, MDS EB1 or EB2\n* Age≥60\n* Ability to read, understand, and communicate fluently in English\n* Ability to understand and comply with study procedures\n* Willingness and ability to provide written informed consent\n\nExclusion Criteria:\n\n* Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the discrete choice experiment.\n* Significant medical conditions, as assessed by the investigators, that would substantially increase the burden on the patient to complete study assessments (such as multiorgan failure, respiratory failure, or other critical illness).'}, 'identificationModule': {'nctId': 'NCT05061095', 'briefTitle': 'Understanding What Matters Most to Patients: Establishing the Validity of a Best-Worst Scaling Survey', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Understanding What Matters Most to Patients: Establishing the Validity of a Best-Worst Scaling Survey', 'orgStudyIdInfo': {'id': 'LCCC 2136'}, 'secondaryIdInfos': [{'id': 'U2CNR014637', 'link': 'https://reporter.nih.gov/quickSearch/U2CNR014637', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Assessment Surveys', 'type': 'OTHER', 'description': 'Patients will complete surveys in three periods. An initial baseline survey, longitudinal assessments completed every 2 weeks over the course of the first three months on study (6 times maximum), and extended assessments that will happen every 3 months after the initial longitudinal period up to 2 years on the study (7 times maximum). Baseline questionnaire will collect demographic and background medical record information. Longitudinal assessments will consist of a BWS questionnaire (patients rate importance of 7 treatment goals), decisional conflict scales, EQ-5D-5L, distress thermometer, and items from PRO-CTCAE. Extended assessments will use same questionnaires as longitudinal assessments.'}, {'name': 'Qualitative Interviews', 'type': 'OTHER', 'description': 'Patients will participate in 2 interviews (1 initial interview, 1 follow up). These will be cognitive interviews focusing on establishing content validity for BWS questionnaire. Will establish patient understanding of questions asked in BWS, understanding of how preferences affect treatment decisions, expected outcomes, and feedback from patients on other potentially important attributes not included in BWS.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Daniel Richardson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}