Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-01 @ 2:34 PM
Study NCT ID:
NCT07144566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Sexual Health in Gynecological Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012736', 'term': 'Sex Education'}], 'ancestors': [{'id': 'D044347', 'term': 'Sexology'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-11', 'size': 464010, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-17T17:25', 'hasProtocol': True}, {'date': '2025-08-13', 'size': 330475, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-17T17:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of the nurse led clinical sexual health dysfunction program', 'timeFrame': '12 weeks', 'description': 'Assess improvement in sexual dysfunction in gynecologic cancer survivors via the Female Sexual Function Index (FSFI).'}, {'measure': 'Effectiveness of the nurse led clinical sexual health dysfunction program', 'timeFrame': '12 weeks', 'description': 'Assess effectiveness of the nurse led clinical sexual dysfunction program via number of referrals and treatments in the chart before and after the intervention in gynecologic cancer patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Survivorship', 'Sexual Health', 'Sexual Dysfunction', 'Gynecologic Cancer'], 'conditions': ['Gynaecologic Cancer']}, 'referencesModule': {'references': [{'pmid': '36800552', 'type': 'RESULT', 'citation': 'Birch K, Chung S, Zion SR, MacEwan JP, Malecki MJ. Incremental Health Care Costs of Anxiety and Depression Among Medicare Beneficiaries With Cancer. JCO Oncol Pract. 2023 May;19(5):e660-e671. doi: 10.1200/OP.22.00555. Epub 2023 Feb 17.'}, {'pmid': '30213412', 'type': 'RESULT', 'citation': 'Sitlinger A, Zafar SY. Health-Related Quality of Life: The Impact on Morbidity and Mortality. Surg Oncol Clin N Am. 2018 Oct;27(4):675-684. doi: 10.1016/j.soc.2018.05.008. Epub 2018 Jul 21.'}, {'pmid': '31167551', 'type': 'RESULT', 'citation': 'Hungr C, Recklitis CJ, Wright AA, Bober SL. How does a single session group intervention improve sexual function in ovarian cancer survivors? A secondary analysis of effects of self-efficacy, knowledge and emotional distress. Psychol Health Med. 2020 Jan;25(1):110-120. doi: 10.1080/13548506.2019.1626452. Epub 2019 Jun 5.'}, {'pmid': '32820237', 'type': 'RESULT', 'citation': 'Wang X, Wang N, Zhong L, Wang S, Zheng Y, Yang B, Zhang J, Lin Y, Wang Z. Prognostic value of depression and anxiety on breast cancer recurrence and mortality: a systematic review and meta-analysis of 282,203 patients. Mol Psychiatry. 2020 Dec;25(12):3186-3197. doi: 10.1038/s41380-020-00865-6. Epub 2020 Aug 20.'}, {'pmid': '33552660', 'type': 'RESULT', 'citation': "Seaborne LA, Peterson M, Kushner DM, Sobecki J, Rash JK. Development, Implementation, and Patient Perspectives of the Women's Integrative Sexual Health Program: A Program Designed to Address the Sexual Side Effects of Cancer Treatment. J Adv Pract Oncol. 2021 Jan-Feb;12(1):32-38. doi: 10.6004/jadpro.2021.12.1.3. Epub 2021 Jan 1."}, {'pmid': '37690804', 'type': 'RESULT', 'citation': 'Chow KM, Chan Yip WHC, Porter-Steele J, Siu KY, Choi KC. Nurse-led sexual rehabilitation to rebuild sexuality and intimacy after treatment for gynaecological cancer: a randomised controlled trial (abridged secondary publication). Hong Kong Med J. 2023 Aug;29 Suppl 4(4):26-30. No abstract available.'}, {'pmid': '36231221', 'type': 'RESULT', 'citation': 'Sousa Rodrigues Guedes T, Barbosa Otoni Goncalves Guedes M, de Castro Santana R, Costa da Silva JF, Almeida Gomes Dantas A, Ochandorena-Acha M, Terradas-Monllor M, Jerez-Roig J, Bezerra de Souza DL. Sexual Dysfunction in Women with Cancer: A Systematic Review of Longitudinal Studies. Int J Environ Res Public Health. 2022 Sep 21;19(19):11921. doi: 10.3390/ijerph191911921.'}, {'pmid': '39269314', 'type': 'RESULT', 'citation': 'Kaufman R, Agrawal L, Teplinsky E, Kiel L, Abioye O, Florez N. From diagnosis to survivorship addressing the sexuality of women during cancer. Oncologist. 2024 Dec 6;29(12):1014-1023. doi: 10.1093/oncolo/oyae242.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test whether a nurse-led program can improve screening and referral rates for sexual dysfunction and improve sexual health care in individuals with gynecological cancer. The main questions it aims to answer are:\n\nDoes participation in a nurse-led program improve the treatment of sexual dysfunction in individuals with gynecological cancer?\n\nDoes the program increase the frequency of screenings and referrals for sexual dysfunction?\n\nParticipants will:\n\nComplete a visit with an advanced practice provider.\n\nFill out the Female Sexual Function Index survey.\n\nAllow the research team to review medical records.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'Female born', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Patients with a gynecologic cancer history\n* Patients ages 30-65 years old\n* Patients must have completed cancer treatment within the past 12 months\n* Patients may be on maintenance therapy\n\nExclusion:\n\n* Any records flagged "break the glass" or "research opt-out."\n* Patients with severe psychiatric disorders that would impair consent or participation\n* Patients with neurological disorders affecting sexual function\n* Patients with a history of sexual violence or sexual assault'}, 'identificationModule': {'nctId': 'NCT07144566', 'briefTitle': 'Improving Sexual Health in Gynecological Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Implementation of a Nurse-Led Clinical Program to Decrease Sexual Dysfunction Among Gynecological Cancer Patient', 'orgStudyIdInfo': {'id': '00004279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse Led Sexual Health Intervention', 'description': 'Gynecologic Cancer patients ages 30-65yo who completed treatment within 12 months will be offered a sexual health nurse led intervention during follow up visits to include a pelvic exam, focused sexual health assessment, sexual health plan of care, sexual health education, and specialty referrals as needed.', 'interventionNames': ['Other: Nurse Led Sexual Health Clinical Program Intervention']}], 'interventions': [{'name': 'Nurse Led Sexual Health Clinical Program Intervention', 'type': 'OTHER', 'otherNames': ['Sexual health education', 'Sexual health treatment plan', 'Sexual Health Referrals', 'Sexual health focused pelvic exam'], 'description': 'In person visit with Advanced Practice Provider (APP) whom is an Advanced Practice Nurse Practitioner in Oncology. Visit will include a focused pelvic exam, sexual health treatment plan, sexual health education, and referrals that follow the current Sexual Health Survivorship NCCN guidelines. A post visit telephone will be provided by the APP 8 weeks after APP visit for follow up questions and further education if needed.', 'armGroupLabels': ['Nurse Led Sexual Health Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '900048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Corina P Hernandez, MSN', 'role': 'CONTACT', 'email': 'corina.hernandez@cshs.org', 'phone': '310-423-6074'}, {'name': 'Leah Spiro, DNP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Corina P Hernandez, MSN', 'role': 'CONTACT', 'email': 'corina.hernandez@cshs.org', 'phone': '310-423-6074'}], 'overallOfficials': [{'name': 'Leah Spiro, DNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Nurse Scientist, Nurse Practitioner, Brawerman Nursing Institute, Principal Investigator', 'investigatorFullName': 'Leah Spiro', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}