Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT03506451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2018-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000086522', 'term': 'Financial Stress'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2018-04-20', 'studyFirstSubmitQcDate': '2018-04-20', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Disease status', 'timeFrame': '5 years post completion of radiation treatment'}, {'measure': 'Overall survival', 'timeFrame': '5 years post completion of radiation treatment'}, {'measure': 'Progression free survival', 'timeFrame': '5 years post completion of radiation treatment'}], 'primaryOutcomes': [{'measure': 'Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC', 'timeFrame': '3 months post radiation therapy'}, {'measure': 'Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC', 'timeFrame': '6 months post radiation therapy'}, {'measure': 'Financial toxicity, as measured by change in Comprehensive Score for financial Toxicity (COST)', 'timeFrame': 'Baseline, 3 months post radiation therapy, 6 months post radiation therapy', 'description': 'Financial toxicity will be measured using the comprehensive score for financial toxicity (COST). The range of the COST score is 0-44.'}], 'secondaryOutcomes': [{'measure': 'Change in symptom burden, as measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) score', 'timeFrame': 'Baseline, 3 months post radiation therapy, 6 months post radiation therapy'}, {'measure': 'Change in quality of life, as measured by FACT-H&N score', 'timeFrame': 'Baseline, 3 months post radiation therapy, 6 months post radiation therapy'}, {'measure': 'Perceived quality of care', 'timeFrame': '3 months post radiation therapy, 6 months post radiation therapy', 'description': 'Patients will be asked to rate the quality of care as excellent, good, fair, poor, or very poor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Financial toxicity'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this single institution, pilot study is to explore the out of pocket (OOP)costs and financial toxicity of cancer care for patients during definitive treatment of head and neck cancer with radiation therapy with or without chemotherapy and surgical resection. The study team will assess how the financial burden of cancer care impacts quality of life as well as treatment-related decision-making from a patient perspective.', 'detailedDescription': "This is a prospective, single institution, survey-based study to assess OOP costs, financial toxicity and pateint reported outcomes (PROs') (including QOL, quality of care, and attitudes/perspectives on the role of cost in treatment decisions). Potential participants are new patient consults in Radiation Oncology Head and Neck Cancer Clinic. Patients with an indication for definitive treatment involving radiation therapy will be approached by study staff and, if amenable, enrolled in the study. After signing informed consent, they will complete a baseline survey assessing socioeconomic household information, baseline symptoms/QOL and baseline costs/financial toxicity. They will be followed prospectively and re-surveyed at 3 and 6 months after completion of radiation therapy. Repeat assessments will document treatment costs and PRO including QOL, financial toxicity, and self-reported quality of care. Patients will be asked to collect all treatment-related bills in a provided binder, which will be reviewed at each survey date. Basic demographic data (including age, sex, race, marital status, zip code, and insurance coverage), comorbidities, smoking status, cancer characteristics (stage, site, histology), treatments received, emergency department visits and hospitalization rates at baseline, end of treatment, 3 months and 6 months after radiation treatment will be collected as part of this study. Disease status and survival will also be assessed from standard of care follow-up visits up to five years after completion of radiation treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (18 years or older) patients\n2. Diagnosed with HNC with treatment plan including definitive radiation therapy or chemotherapy/radiation therapy\n3. Be able to read and write in English\n4. Able to give informed consent and complete survey materials\n\nExclusion Criteria:\n\n1. Recurrent disease\n2. Metastatic disease\n3. Prior radiation courses must be approved by PI prior to approaching patient for enrollment (prior systemic therapy is not an exclusion to study enrollment).'}, 'identificationModule': {'nctId': 'NCT03506451', 'acronym': 'PaRTNer', 'briefTitle': 'PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study', 'orgStudyIdInfo': {'id': 'Pro00092590'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm non-therapeutic interventional study', 'description': 'All subjects who enroll on study will be asked to complete questionnaires at baseline before treatment starts; the questionnaires are repeated at one month, three and six months after radiation therapy has been completed. the demographics questionnaire is completed at baseline only; the FACT-HN is completed at all four time points.', 'interventionNames': ['Other: Demographics questionnaires and the FACT HN questionnaire']}], 'interventions': [{'name': 'Demographics questionnaires and the FACT HN questionnaire', 'type': 'OTHER', 'description': 'Patients will complete a baseline survey assessing socioeconomic household information, baseline symptoms, QOL, and financial toxicity, as well as attitudes toward cost conversations and educational handouts.', 'armGroupLabels': ['Single arm non-therapeutic interventional study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Pooja Karukonda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Health System (DUHS)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}