Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT06121258
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of the educational video series after six-months of access and use by breast cancer patients as measured by AIM instrument.', 'timeFrame': '6 months', 'description': 'The Acceptability of Intervention Measure (AIM) is a validated instrument used to measure the acceptability of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater acceptability).'}, {'measure': 'Appropriateness of the educational video series after six-months of access and use by breast cancer patients as measured by IAM instrument.', 'timeFrame': '6 months', 'description': 'The Intervention Appropriateness Measure (IAM) is a validated instrument used to measure the appropriateness of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater appropriateness).'}, {'measure': 'Determine the sustainability of the educational video series after six-months of access and use by breast cancer patients as measured by the FIM instrument.', 'timeFrame': '6 months', 'description': 'The Feasibility of Intervention Measure (FIM) is a validated instrument used to measure the feasibility, or sustainability, of an intervention. Scores range from 0-5. There is no score cut off, however higher scores indicate better outcomes (greater feasibility).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in sexual health and function at six-months, as measured by the PROMIS Sexual Function v2 Brief Profile (Female)', 'timeFrame': 'Baseline, 6 months', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function v2 Brief Profile (Female) is a well-validated tool in oncology patients to assess sexual health. Calibrated subdomain scores are expressed as T-scores (mean=50, standard deviation=10). A T-score 50 corresponds to the mean response among cancer survivors used for previous item testing. Higher scores indicate better outcomes within the domain. We will assess the change at 6 months from baseline.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'sexual health', 'educational video'], 'conditions': ['Breast Cancer Female', 'Sexual Dysfunction']}, 'referencesModule': {'references': [{'pmid': '27492424', 'type': 'BACKGROUND', 'citation': 'Tat S, Doan T, Yoo GJ, Levine EG. Qualitative Exploration of Sexual Health Among Diverse Breast Cancer Survivors. J Cancer Educ. 2018 Apr;33(2):477-484. doi: 10.1007/s13187-016-1090-6.'}, {'pmid': '25534170', 'type': 'BACKGROUND', 'citation': 'Sporn NJ, Smith KB, Pirl WF, Lennes IT, Hyland KA, Park ER. Sexual health communication between cancer survivors and providers: how frequently does it occur and which providers are preferred? Psychooncology. 2015 Sep;24(9):1167-73. doi: 10.1002/pon.3736. Epub 2014 Dec 22.'}, {'pmid': '12618871', 'type': 'BACKGROUND', 'citation': 'Stead ML, Brown JM, Fallowfield L, Selby P. Lack of communication between healthcare professionals and women with ovarian cancer about sexual issues. Br J Cancer. 2003 Mar 10;88(5):666-71. doi: 10.1038/sj.bjc.6600799.'}, {'pmid': '28547655', 'type': 'BACKGROUND', 'citation': 'Stabile C, Goldfarb S, Baser RE, Goldfrank DJ, Abu-Rustum NR, Barakat RR, Dickler MN, Carter J. Sexual health needs and educational intervention preferences for women with cancer. Breast Cancer Res Treat. 2017 Aug;165(1):77-84. doi: 10.1007/s10549-017-4305-6. Epub 2017 May 25.'}, {'pmid': '35915298', 'type': 'BACKGROUND', 'citation': 'Huynh V, Vemuru S, Hampanda K, Pettigrew J, Fasano M, Coons HL, Rojas KE, Afghahi A, Ahrendt G, Kim S, Matlock DD, Tevis SE. No One-Size-Fits-All: Sexual Health Education Preferences in Patients with Breast Cancer. Ann Surg Oncol. 2022 Oct;29(10):6238-6251. doi: 10.1245/s10434-022-12126-7. Epub 2022 Aug 1.'}, {'pmid': '28851459', 'type': 'BACKGROUND', 'citation': 'Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.'}, {'pmid': '23387911', 'type': 'BACKGROUND', 'citation': 'Flynn KE, Lin L, Cyranowski JM, Reeve BB, Reese JB, Jeffery DD, Smith AW, Porter LS, Dombeck CB, Bruner DW, Keefe FJ, Weinfurt KP. Development of the NIH PROMIS (R) Sexual Function and Satisfaction measures in patients with cancer. J Sex Med. 2013 Feb;10 Suppl 1(0 1):43-52. doi: 10.1111/j.1743-6109.2012.02995.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the acceptability, appropriateness, and feasibility of a educational video series for patients going through breast cancer treatment.', 'detailedDescription': 'This is a prospective, mixed methods pilot study to evaluate the acceptability, appropriateness, and feasibility of a novel educational video series for patients going through breast cancer treatment. The video series addresses topics such as what to expect from breast surgery, how to prepare for breast surgery, treatment effects of breast cancer therapies, and mitigation and communication strategies for navigating breast cancer treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage I-III invasive breast cancer within one month of initial multi-disciplinary clinic visit or surgical consultation\n* Ability to complete survey material independently\n* Able to read and speak English\n* Willingness to comply with study material and procedures\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Stage 0 or IV breast cancer\n* Non-breast cancer diagnoses\n* History of anti-hormonal therapy, chemotherapy, or radiotherapy not related to breast cancer\n* Prior breast cancer diagnosis'}, 'identificationModule': {'nctId': 'NCT06121258', 'briefTitle': 'Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment', 'orgStudyIdInfo': {'id': '23-1734.cc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video website access', 'description': 'Participants will gain access to the educational video website in order to watch the series.', 'interventionNames': ['Other: Educational video series']}], 'interventions': [{'name': 'Educational video series', 'type': 'OTHER', 'description': 'The intervention is a web-based educational video series that was developed using a patient-centered approach that discusses breast cancer treatment, sexual health side effects, and provides treatment and mitigation strategies for these side effects.', 'armGroupLabels': ['Video website access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Sarah E Tevis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}