Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT06072833
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2023-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterizing and Addressing Financial Toxicity in AYAs With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants who screen positive all move forward to receive the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of (OR percentage of) participants who completed the intervention', 'timeFrame': 'Up to 6 months', 'description': 'This is to assess the feasibility of intervention completion. Intervention completion is defined as participants who have demonstrated contact with community partners at any time before the end of 6 months.'}, {'measure': 'Percentage of eligible participants who consented to be in study', 'timeFrame': 'Up to 6 months', 'description': 'This is to measure interest and the need for help by community partners that can provide patient financial education and navigation.'}], 'secondaryOutcomes': [{'measure': 'Comprehensive Score of Financial Toxicity (COST measure)', 'timeFrame': 'Baseline, 6 months', 'description': 'The COST is a patient-reported outcome measure that describes the financial distress experienced by cancer patients. It is a 11-item questionnaire with a score range of 0-44. Lower COST values indicate higher toxicity. Higher scores indicate lower financial toxicity .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Adolescents', 'Young Adults', 'Financial Needs', 'Social Needs', 'Minority health', 'Caregivers'], 'conditions': ['Cancer in Adolescence']}, 'referencesModule': {'references': [{'pmid': '23442307', 'type': 'BACKGROUND', 'citation': "Zafar SY, Peppercorn JM, Schrag D, Taylor DH, Goetzinger AM, Zhong X, Abernethy AP. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient's experience. Oncologist. 2013;18(4):381-90. doi: 10.1634/theoncologist.2012-0279. Epub 2013 Feb 26."}, {'pmid': '27754926', 'type': 'BACKGROUND', 'citation': 'Altice CK, Banegas MP, Tucker-Seeley RD, Yabroff KR. Financial Hardships Experienced by Cancer Survivors: A Systematic Review. J Natl Cancer Inst. 2016 Oct 20;109(2):djw205. doi: 10.1093/jnci/djw205. Print 2017 Feb.'}, {'pmid': '26644532', 'type': 'BACKGROUND', 'citation': 'Yabroff KR, Dowling EC, Guy GP Jr, Banegas MP, Davidoff A, Han X, Virgo KS, McNeel TS, Chawla N, Blanch-Hartigan D, Kent EE, Li C, Rodriguez JL, de Moor JS, Zheng Z, Jemal A, Ekwueme DU. Financial Hardship Associated With Cancer in the United States: Findings From a Population-Based Sample of Adult Cancer Survivors. J Clin Oncol. 2016 Jan 20;34(3):259-67. doi: 10.1200/JCO.2015.62.0468. Epub 2015 Dec 7.'}, {'pmid': '22614977', 'type': 'BACKGROUND', 'citation': 'Parsons HM, Harlan LC, Lynch CF, Hamilton AS, Wu XC, Kato I, Schwartz SM, Smith AW, Keel G, Keegan TH. Impact of cancer on work and education among adolescent and young adult cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2393-400. doi: 10.1200/JCO.2011.39.6333. Epub 2012 May 21.'}, {'pmid': '28817372', 'type': 'BACKGROUND', 'citation': 'Nipp RD, Kirchhoff AC, Fair D, Rabin J, Hyland KA, Kuhlthau K, Perez GK, Robison LL, Armstrong GT, Nathan PC, Oeffinger KC, Leisenring WM, Park ER. Financial Burden in Survivors of Childhood Cancer: A Report From the Childhood Cancer Survivor Study. J Clin Oncol. 2017 Oct 20;35(30):3474-3481. doi: 10.1200/JCO.2016.71.7066. Epub 2017 Aug 17.'}, {'pmid': '27716900', 'type': 'BACKGROUND', 'citation': "de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7."}, {'pmid': '34699110', 'type': 'BACKGROUND', 'citation': 'Danhauer SC, Canzona M, Tucker-Seeley RD, Reeve BB, Nightingale CL, Howard DS, Puccinelli-Ortega N, Little-Greene D, Salsman JM. Stakeholder-informed conceptual framework for financial burden among adolescents and young adults with cancer. Psychooncology. 2022 Apr;31(4):597-605. doi: 10.1002/pon.5843. Epub 2021 Nov 5.'}, {'type': 'BACKGROUND', 'citation': 'Beauchemin MP, Elkin EB, Wright JD, Kukafka R, Hershman DL, Kahn J. Incorporating systematic financial screening into the electronic health record. Journal of Clinical Oncology. 2021;39(28_suppl):184-184.'}, {'pmid': '40726516', 'type': 'DERIVED', 'citation': 'Khurana RK, Valera K, Raghunathan R, Gallagher KD, Angove RS, Bradshaw E, Patton J, Alvarado S, Crespo S, Judon K, DiCola K, Steinberg DM, Wang S, Hershman DL, Beauchemin MP. Pilot feasibility of a financial and health-related social needs navigation intervention (AYA-NAV) for adolescents and young adults with Cancer: Study protocol for a prospective, single-arm study. Contemp Clin Trials Commun. 2025 Jul 16;47:101523. doi: 10.1016/j.conctc.2025.101523. eCollection 2025 Oct.'}]}, 'descriptionModule': {'briefSummary': 'The overall aims of this study are to address two important gaps in care for AYA cancer patients: 1) a financial toxicity measurement tool to assess AYA-specific needs, and 2) an intervention for mitigating financial toxicity in this population. Aim 1 involves adapting the COSTA measure and assessing the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. Aim 2 and 3 involve the development and pilot testing of our novel financial education/ navigation (FE/FN) intervention.', 'detailedDescription': 'Financial toxicity is the harmful personal financial burden faced by patients due to healthcare needs. A prevalent adverse outcome of cancer therapy, financial toxicity is associated with poorer health outcomes and increased mortality in adults with cancer. Among cancer survivors, financial burden disproportionately impacts adolescents and young adults (AYA: 15 - 39 years). Lack of financial security, insurance gaps or under-insurance, and interruptions in education or careers caused by cancer therapy make AYA cancer survivors particularly vulnerable to financial burden. Financial toxicity of cancer care is an actionable factor impacting outcomes among vulnerable AYA populations. In order to improve outcomes and reduce the burden of care among these populations, targeted, appropriate measures and then, age-specific interventions are needed. The study includes the following aims: Aim 1 involves the adaptation of the COST measure and assessment of the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. The study team will administer COST and additional AYA-specific financial toxicity candidate items to N=150 AYAs. The study will assess validity of original COST through confirmatory factor analysis; assess reliability through test/retest; conduct exploratory factor analysis on modified COST incorporating added items; and describe AYA-reported acceptability of AYA financial toxicity assessment.\n\nIn Aim 2, an adapted FN/FE intervention will be adapted for a racial/ethnically diverse group of AYAs. 6 focus groups (6 - 8 per group) will be conducted with a diverse AYAs and caregivers, and brief stakeholder discussions to understand unique AYA FE/FN needs and inform intervention refinement.\n\nAim 3 will include a pilot test of our novel FE/FN intervention to AYAs. A FE/FN intervention will be delivered to at least N=30 AYAs, and assess feasibility by evaluating program completion (6-months), participant-reported acceptability. Evidence of efficacy will be recorded by measuring improvement in average financial toxicity score between baseline and 6-month time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAYA patient participants:\n\n* Age 15 - 39 years old\n* English or Spanish-speaking\n* Diagnosed with cancer that required treatment within past 18 months\n* Not currently on hospice care\n\nCaregiver/financial partner participants:\n\n* Parent or financially-responsible adult of non-adult AYA (\\<18 years) OR\n* Identified by the AYA as caregiver, parent, or partner who is financially-responsible or a financial partner for AYA\n\nExclusion Criteria:\n\n* Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)'}, 'identificationModule': {'nctId': 'NCT06072833', 'briefTitle': 'Characterizing and Addressing Financial Toxicity in AYAs With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults With Cancer', 'orgStudyIdInfo': {'id': 'AAAU2405'}, 'secondaryIdInfos': [{'id': '5KL2TR001874', 'link': 'https://reporter.nih.gov/quickSearch/5KL2TR001874', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient Financial Education / Navigation', 'description': 'Individuals who screen positive will all move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months.', 'interventionNames': ['Behavioral: Patient Financial Education / Navigation']}], 'interventions': [{'name': 'Patient Financial Education / Navigation', 'type': 'BEHAVIORAL', 'description': 'The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.', 'armGroupLabels': ['Patient Financial Education / Navigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Melissa Beauchemin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient Advocate Foundation', 'class': 'UNKNOWN'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Nursing', 'investigatorFullName': 'Melissa Beauchemin', 'investigatorAffiliation': 'Columbia University'}}}}