Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT04930159
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 252}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-06-11', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment completion (relative dose)', 'timeFrame': '6 months', 'description': 'Relative dose is the ratio of actual-to-expected total dose of treatment received. The calculation of expected total dose will be made from the baseline treatment recommendation data collected at enrollment.'}], 'secondaryOutcomes': [{'measure': 'Patient-reported social isolation (SPS-24)', 'timeFrame': '6 months', 'description': 'The Social Provisions Scale (SPS) is one of the most frequently used scales on social support, and is validated to measure the components of social support that directly impact health outcomes: attachment, social integration, reassurance of worth, reliable alliance, guidance, and opportunity for nurturance.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '38348827', 'type': 'DERIVED', 'citation': 'Oluloro A, Comstock B, Monsell SE, Gross M, Wolff EM, Sage L, Alson J, Lavallee DC, Hempstead B, Moore A, Katz R, Doll KM. Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial. J Comp Eff Res. 2024 Mar;13(3):e230159. doi: 10.57264/cer-2023-0159. Epub 2024 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'The SISTER study is a randomized trial, looking at various modalities of social support for Black patients undergoing treatment for endometrial cancer. There are three study arms: group support, 1:1 peer support, and enhanced usual care. The primary outcome is treatment completion, and the secondary outcome is social isolation.', 'detailedDescription': 'SISTER is a prospective, open randomized controlled trial of U.S. Black/African-American people with high-risk endometrial cancer requiring treatment with chemotherapy, radiation, or immunotherapy. We will compare social support interventions of enhanced usual care, weekly group-based support, and 1:1 peer support to determine the most effective option to improve treatment completion and decrease social isolation.\n\nThe SISTER study comparators are based on multiple systematic reviews of peer support literature, input from the multi-stakeholder Steering Group of the Endometrial Cancer Action Network for African Americans (ECANA), two focus groups of Black women with EC, and cancer center leadership at selected enrollment sites. The core function of each comparator is to decrease social isolation for women on active treatment. Of the peer support intervention options available, the SISTER study includes the two that have the most data collected among Black women with cancer, have been most efficacious with regard to social isolation9 and treatment completion, and were enthusiastically supported by ECANA patient partners and focus group data.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult 18 years of age or older; and\n2. Self-identify as Black/African American\n3. Presenting with high-risk EC established by anatomic pathology as tumor stage and grade classification by the following:\n\n 1. Pathology documentation from any hospital/clinic/medical center, and\n 2. FIGO Stage 1A with Grade 2, Grade 3, or Grade 4 of any histology type or\n 3. FIGO Stage 1A with non-endometrioid (carcinosarcoma, serous, clear cell, undifferentiated or mixed) histology\n 4. FIGO Stage 1B, 2, 3, or 4 of any grade or histology\n 5. Recurrent endometrial cancer of any stage or grade\n4. Documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy.\n\nExclusion Criteria:\n\nParticipants must not have any of the following exclusion criteria:\n\n1. Newly diagnosis of FIGO Stage IA Grade 1 endometrioid adenocarcinoma\n2. Previous history of other cancer diagnosis requiring chemotherapy, radiation therapy, or immunotherapy within the past 12 months;\n3. Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;\n4. Contraindication to all non-surgical therapy available for endometrial cancer (i.e., chemotherapy, radiation, and immunotherapy contraindicated);\n5. Enrollment into hospice prior to randomization\n6. Unable to provide written informed consent in English;\n7. Unable to be contacted for research surveys;\n8. Recent hospitalization for psychiatric illness in the past 6 months'}, 'identificationModule': {'nctId': 'NCT04930159', 'acronym': 'SISTER', 'briefTitle': 'Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence', 'orgStudyIdInfo': {'id': 'STUDY00012990'}, 'secondaryIdInfos': [{'id': 'RG1121627', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'NCI-2021-12773', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Enhanced usual care', 'description': 'Written materials in an appealing package.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Facilitated group support', 'description': 'Weekly group gatherings.', 'interventionNames': ['Behavioral: Facilitated group support']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1:1 Peer Support', 'description': 'Individual peer support calls.', 'interventionNames': ['Behavioral: 1:1 Peer Support']}], 'interventions': [{'name': 'Facilitated group support', 'type': 'BEHAVIORAL', 'description': 'Weekly group gatherings where content will alternate between group conversation and focused topics (e.g., treatment side-effects, mental health, family dynamics, nutrition, financial hardship) with facilitated discussion by a trained professional in nutrition, psychotherapy, cognitive behavioral therapy, or medicine. Each group will cycle through the same order of topics.', 'armGroupLabels': ['Facilitated group support']}, {'name': '1:1 Peer Support', 'type': 'BEHAVIORAL', 'description': '1:1 peer support via telephone or video either during or near a treatment visit. Call content will be focused on social support and driven by the needs of the participant.', 'armGroupLabels': ['1:1 Peer Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Rebecca Arend, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Heather Williams, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Navya Nair, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Nita Lee, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Tara Castellano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Louisiana State University - New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER study', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Katherine Stewart, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Charlotte Gamble, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Health Research Institute', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Eloise Chapman-Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Victoria Bae-Jump, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '844-374-7837'}, {'name': 'Sarah Lynam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}, {'name': 'Kemi M Doll, MD, MSCR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Kemi M Doll, MD, MS', 'role': 'CONTACT', 'email': 'kdoll@uw.edu', 'phone': '206-543-3669'}, {'name': 'SISTER team', 'role': 'CONTACT', 'email': 'sisterstudy@uw.edu', 'phone': '1-844-374-7837'}], 'overallOfficials': [{'name': 'Kemi M Doll, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The time frame is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board', 'ipdSharing': 'YES', 'description': 'Only de-identified data will be shared with other researchers. Researchers will be required to receive approval from the SISTER Advocate Advisory Board to receive data.', 'accessCriteria': 'The access criteria is to be determined, in partnership with the SISTER Executive Committee and Advocate Advisory Board'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, School of Medicine', 'investigatorFullName': 'Kemi Doll', 'investigatorAffiliation': 'University of Washington'}}}}