Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 8:35 AM
Study NCT ID:
NCT06664034
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervening on Women's Health for Rural Young Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single arm pilot hybrid type I trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2024-10-27', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of patient's engagement in goal-concordant reproductive health care", 'timeFrame': '12 weeks after oncology visit', 'description': "Study staff will be trained to abstract the primary outcome from the patient's medical records using standardized case report forms. Engagement in goal-concordant reproductive health care will be assigned to patients who undergo: 1) reproductive health needs screen and have no needs, OR 2) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, and have no further needs; OR 3) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, have a need, undergo a telehealth reproductive health consultation, and have no reproductive health service needs; OR 4) reproductive health needs screen, complete a navigation session and receive reproductive health counseling and management strategies, have a need, undergo a telehealth reproductive health consultation, have a reproductive health service needs, and uptake appropriate services."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reproductive health', 'Oncofertility'], 'conditions': ['Cancer', 'Fertility Issues', 'Contraception']}, 'descriptionModule': {'briefSummary': "The purpose of this pilot study is to evaluate the feasibility of a multi-component intervention to improve young female cancer survivors' engagement in goal-concordant reproductive health care. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant reproductive health care."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer (Stages 0-IV) diagnosis\n* Primary language English or Spanish\n* Receiving oncology care at rural oncology clinical participating site\n* Living in Imperial County, California\n\nExclusion Criteria:\n\n\\- Women who are pregnant at recruitment'}, 'identificationModule': {'nctId': 'NCT06664034', 'briefTitle': "Intervening on Women's Health for Rural Young Cancer Survivors", 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': "Intervening on Women's Health for Rural Young Cancer Survivors", 'orgStudyIdInfo': {'id': 'U54800646'}, 'secondaryIdInfos': [{'id': '5U54CA285115-02', 'link': 'https://reporter.nih.gov/quickSearch/5U54CA285115-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-component intervention', 'description': 'After the intervention implementation, all cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component intervention.', 'interventionNames': ['Behavioral: Multi-component reproductive health care intervention']}], 'interventions': [{'name': 'Multi-component reproductive health care intervention', 'type': 'BEHAVIORAL', 'description': "The multi-component reproductive health care intervention includes:\n\n1. Young cancer patients presenting to oncology visits will complete a clinic-based reproductive health needs screen with a member of the clinical team. This needs screen assesses i) desire to have a child in the future and ii) need for contraception.\n2. Reproductive health patient navigation consists of one telehealth or in-person session with a social worker to: i) assess the patient's reproductive health needs, ii) provide individualized patient education and counseling on a) infertility risk related to cancer type and treatment and b) screening and management strategies for reproductive health needs, iii) provide support with the goal of engaging in goal-concordant reproductive health care.\n3. Telehealth reproductive health consultation will occur between the patient and reproductive specialist. Each consultation is estimated to be 1 hour.", 'armGroupLabels': ['Multi-component intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92227', 'city': 'Brawley', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'San Diego State University - Imperial Valley/ School of Nursing', 'geoPoint': {'lat': 32.97866, 'lon': -115.53027}}, {'zip': '92243', 'city': 'El Centro', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Cancer Resource Center of the Desert', 'geoPoint': {'lat': 32.792, 'lon': -115.56305}}, {'zip': '92243', 'city': 'El Centro', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'H. Irene Su, MD, MSCE', 'role': 'CONTACT', 'email': 'hisu@health.ucsd.edu'}], 'facility': 'El Centro Regional Medical Center', 'geoPoint': {'lat': 32.792, 'lon': -115.56305}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Califiornia San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Sally Romero, PhD, MPH', 'role': 'CONTACT', 'email': 'saromero@health.ucsd.edu', 'phone': '858-822-1371'}, {'name': 'H. Irene Su, MD, MSCE', 'role': 'CONTACT', 'email': 'hisu@health.ucsd.edu', 'phone': '858-822-5986'}], 'overallOfficials': [{'name': 'H. Irene Su, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.', 'ipdSharing': 'YES', 'description': 'Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.', 'accessCriteria': 'Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to the principal investigator (H. Irene Su).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Diego State University', 'class': 'OTHER'}, {'name': 'Cancer Resource Center of the Desert', 'class': 'UNKNOWN'}, {'name': 'El Centro Regional Medical Center', 'class': 'UNKNOWN'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hui-Chun Irene Su', 'investigatorAffiliation': 'University of California, San Diego'}}}}