Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT07282158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D000073219', 'term': 'Memory and Learning Tests'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective 1: Clinician feedback for Helping Ovarian Cancer Patients Cope-Clinician Burnout (HOPE-C)', 'timeFrame': 'Day 1', 'description': "Will assess clinician's feedback around the content, delivery structure, and materials for the adapted HOPE-C intervention. Qualitative Description will be used to analyze the data."}, {'measure': 'Objective 2: Feasibility (Accrual rate)', 'timeFrame': 'At time of enrollment', 'description': 'Feasibility cutoff includes ≥ 50% of eligible clinicians enrolling in the study.'}, {'measure': 'Objective 2: Feasibility (Rate of intervention completion)', 'timeFrame': 'At 4 weeks', 'description': 'Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all sessions.'}, {'measure': 'Objective 2: Feasibility (Rate of survey completion)', 'timeFrame': 'At baseline and 2-week post-intervention', 'description': 'Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all surveys.'}, {'measure': 'Objective 2: Acceptability of HOPE-C', 'timeFrame': 'At 2-week post-intervention', 'description': 'Assessed by the Theoretical Framework of Acceptability (TFA) questionnaire, which is an 8-item questionnaire assessing acceptability of healthcare interventions across seven constructions: Affective Attitude, Burden, Ethicality, Intervention Coherence, Opportunity Costs, Perceived Effectiveness and Self-efficacy. Items are rated on a 5-point Likert scale (e.g., 1 = strongly dislike, 5 = strongly like) and a mean is computed across all seven constructs (n=7 items) and a single outcome is examined for the general item. Total mean score ranges from 1 to 5, with higher scores indicating greater acceptability of the intervention.'}, {'measure': 'Objective 2: Satisfaction of HOPE-C', 'timeFrame': 'At 2-week post-intervention', 'description': 'Will be assessed by using three items assessing overall satisfaction. A cutoff score of ≥ 7 (out of 10) will be used for each satisfaction item.'}, {'measure': 'Objective 3: Optimization of the intervention', 'timeFrame': 'At 2-week post-intervention', 'description': 'Feedback will be gathered from clinicians who participated in the intervention to assess their feedback on how to optimize the intervention in clinical settings.'}, {'measure': 'Objective 3: Delivery of the intervention', 'timeFrame': 'At 2-week post-intervention', 'description': 'Feedback will be gathered from clinicians who participated in the intervention to assess their feedback on the delivery of the intervention in clinical settings.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Carcinoma', 'Psychiatric Disorder']}, 'descriptionModule': {'briefSummary': 'This clinical trial tests an adapted version of the Helping Ovarian Cancer Patients Cope (HOPE) intervention to address burnout among gynecologic oncology clinicians. Stress and burnout among gynecologic oncology clinicians can have far-reaching impacts not only on physicians at the individual level (e.g., distress, mental illness) but also at the professional (e.g., worse patient outcomes, increased errors) and societal levels (fewer physicians in this specialty, more system strain). The original Helping Ovarian Cancer Patients Cope (HOPE) is a workshop to promote hope among patients with ovarian cancer through creating positive narratives using the hope theory and social-cognitive theory. The adapted intervention for clinicals (HOPE-C) will use the same concepts but tailored to clinician experiences by fostering peer support and retelling their challenging stories and may address burnout for gynecologic oncology clinicians.', 'detailedDescription': "OUTLINE:\n\nOBJECTIVE 1 DEVELOPMENT OF INTERVENTION: Clinicians review HOPE-C intervention materials and complete an interview and questionnaire on study.\n\nOBJECTIVE 2 PILOT TRIAL: Clinicians attend HOPE-C sessions (changing their narrative, managing life's uncertainty and finding meaning) once weekly for 4 weeks, with each session lasting approximately 30-45 minutes. Clinicians complete a questionnaire before and after completing all HOPE-C sessions.\n\nOBJECTIVE 3: Clinicians may undergo an interview after completing HOPE-C sessions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years of age or older\n* English speaking\n* Able to provide informed consent\n* Working with patients with ovarian cancer (gynecologic oncologists, medical oncologists, nurses, social workers, and advance practice providers \\[APPs\\])'}, 'identificationModule': {'nctId': 'NCT07282158', 'briefTitle': 'Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Adaptation of Helping Ovarian Cancer Patients Cope (HOPE) for Clinician Burnout (HOPE-C)', 'orgStudyIdInfo': {'id': 'RG1125922'}, 'secondaryIdInfos': [{'id': 'NCI-2025-07869', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HOPE-C intervention', 'description': "OBJECTIVE 1 DEVELOPMENT OF INTERVENTION: Clinicians review HOPE-C intervention materials and complete an interview and questionnaire on study. Feedback from Objective 1 will be incorporated into the HOPE-C intervention delivered in Objective 2.\n\nOBJECTIVE 2 PILOT TRIAL: Clinicians attend HOPE-C sessions (changing their narrative, managing life's uncertainty and finding meaning) once weekly for 4 weeks, with each session lasting approximately 30-45 minutes. Clinicians complete a questionnaire before and after completing all HOPE-C sessions.\n\nOBJECTIVE 3: Clinicians may undergo an interview after completing HOPE-C sessions.", 'interventionNames': ['Behavioral: Behavioral Intervention', 'Other: Interview', 'Other: Survey Administration']}], 'interventions': [{'name': 'Behavioral Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Behavior Conditioning Therapy', 'Behavior Modification', 'Behavior or Life Style Modifications', 'Behavior Therapy', 'Behavioral Interventions', 'Behavioral Modification', 'Behavioral Therapy', 'Behavioral Treatment', 'Behavioral Treatments', 'Behavioural'], 'description': 'Complete HOPE-C sessions', 'armGroupLabels': ['HOPE-C intervention']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Complete interview', 'armGroupLabels': ['HOPE-C intervention']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['HOPE-C intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'contacts': [{'name': 'Megan J. Shen, PhD', 'role': 'CONTACT', 'email': 'mshen2@fredhutch.org', 'phone': '206-667-4172'}, {'name': 'Megan J. Shen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Megan J. Shen, PhD', 'role': 'CONTACT', 'email': 'mshen2@fredhutch.org', 'phone': '206-667-4172'}], 'overallOfficials': [{'name': 'Megan J. Shen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Andy Hill CARE Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}