Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT05609435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2022-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, trial of REASSURE vs usual care within UW Health oncology clinics'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Who Received Recommended Cancer Care', 'timeFrame': 'up to 18 months', 'description': 'Receipt of recommended cancer care over 18-months (chart review, yes/no)'}, {'measure': "Survivors' Experiences: Impact of Event Scale", 'timeFrame': 'up to 18 months', 'description': 'Impact of Event Scale (measure of cancer-related anxiety) is a 15-item survey scored on a 5 point likert scale for a total possible range of scores from 15-75 where higher scores indicate higher anxiety.'}, {'measure': "Survivors' Experiences: Satisfaction with Information", 'timeFrame': 'up to 18 months', 'description': 'Satisfaction with Information is measured using a 14-item survey scored on a 5 point likert scale for a total possible range of scores from 14-70 where higher scores indicate increased satisfaction with information.'}, {'measure': "Survivors' Experiences: Human Connection Scale Score", 'timeFrame': 'up to 18 months', 'description': 'Human Connection Scale (measure of therapeutic alliance with providers) is a 10-item survey measured on a 5 point likert scale for a total possible range of scores from 10 to 50 where higher scores indicate higher connection with provider.'}, {'measure': "Survivors' Experiences: Quality of Follow Up Care", 'timeFrame': 'up to 18 months', 'description': 'Quality of follow-up care using the question: "How would you rate the quality of follow-up care you received in the past 2 years?" This scored from 1 (poor) to 5 (excellent).'}, {'measure': 'Healthcare Utilization: Number of Visits and Services Used', 'timeFrame': 'up to 18 months', 'description': 'Healthcare utilization is measured via chart review, and includes use of ancillary services, visits with primary care, visits to urgent care/emergency room.'}, {'measure': 'Healthcare Utilization: Number of MyChart Visits and Phone Calls', 'timeFrame': 'up to 18 months', 'description': 'Healthcare utilization is measured via chart review, and includes number of my-chart visits and documented phone calls during 18 month study period.'}], 'primaryOutcomes': [{'measure': 'Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 1', 'timeFrame': 'up to 18 months', 'description': "Survivors' preparedness for survivorship will be assessed using Part 1 of the Preparing for Life as a (New) Survivor (PLANS) scale. This is an 11-item survey scored on a 4 point likert scale for a total possible range of score from 11 - 44 where higher scores indicate increased preparedness."}, {'measure': 'Preparing for Life as a (New) Survivor (PLANS) Scale Score: Part 2', 'timeFrame': 'up to 18 months', 'description': "Survivors' confidence about follow-up will be assessed using Part 2 of the Preparing for Life as a (New) Survivor (PLANS) scale. This is a 5-item survey scored on a 10 point likert scale for a total possible range of score from 5 - 50 where higher scores indicate increased confidence."}], 'secondaryOutcomes': [{'measure': 'Number of Participants In Intervention Arm who would recommend this approach to follow-up to other survivors', 'timeFrame': 'up to 18 months', 'description': 'REASSURE will be considered acceptable if ≥80% of survivors in the REASSURE arm respond "yes" to, "Would you recommend this approach to follow-up to other survivors?".'}, {'measure': 'Number of Threshold-Level Symptoms Reported on the PRO Assessment', 'timeFrame': 'up to 18 months', 'description': 'The number of threshold-level symptoms reported on the Patient Reported Outcome (PRO) assessment at each follow-up time point will be reported. This is based on the investigators\' previously established thresholds of symptoms or concerns that warrant a visit. Some symptoms were "hard stops", meaning any reported symptom triggered a visit, other symptoms triggered a visit based on severity or level of interference.'}, {'measure': 'Number of Threshold-Level Symptoms Survivors Perceive are Addressed on each visit', 'timeFrame': 'up to 18 months'}, {'measure': 'Number of Follow Up Visits', 'timeFrame': 'up to 18 months', 'description': 'The number of follow-up visits over the 18-month follow-up period will be counted. All follow-up visits that occur in medical oncology, radiation oncology, surgery, and survivorship clinics, including both physician and advanced practice provider visits will be counted.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['follow up care', 'low risk', 'health care delivery'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "This study tests a novel intervention designed to optimize needed survivorship care for low-risk breast cancer survivors while reducing burdensome care with limited health benefits. This study examines whether the intervention, titled REASSURE, improves survivors' preparedness for survivorship. Up to 110 participants will be on study for up to 18 months.", 'detailedDescription': "The investigators plan a single site prospective, randomized, trial that will compare the effect of REASSURE on survivor preparedness against usual care. Survivors will be identified from breast oncology clinics within UW Health.\n\nREASSURE is comprised of three components: 1) the REASSURE PRO assessment, which assesses survivors' symptoms and/or concerns, 2) a recommendation for or against a follow-up visit based on survivors reported symptoms /concerns using pre-established thresholds, and 3) REASSURE survivorship messaging.\n\n* Primary Objective\n\n * Compare survivors' preparedness for survivorship with REASSURE versus usual care.\n* Secondary Objectives\n\n * Determine the acceptability of REASSURE for survivors living in rural and non-rural areas.\n * Assess changes in survivor reported symptoms and number of follow-up visits with REASSURE versus usual care."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stage I, ER and/or PR positive, her2neu negative breast cancer within the last 6-24 monoths\n* Willing to complete study procedures using email\n\nExclusion Criteria:\n\n* Receipt of chemotherapy for the stage I ER and/or PR positive, her2neu negative breast cancer diagnosed within the last 6-24 months\n* Participants will be excluded if they are unable to read and write in English or if, in the opinion of a treating clinician, have cognitive impairment that would prevent completion of study procedures\n* Pregnancy, based on patient self-report. If a patient becomes pregnant during the study period, they will be removed from the study at that time.\n* Diagnosis of a ER and PR negative, her2neu negative breast cancer or a her2neu positive breast cancer within the last 5 years'}, 'identificationModule': {'nctId': 'NCT05609435', 'briefTitle': 'Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Evaluating a Novel Follow-up Intervention to Improve the Delivery of Follow-up Care for Low-Risk Breast Cancer Survivors in Wisconsin', 'orgStudyIdInfo': {'id': 'UW22095'}, 'secondaryIdInfos': [{'id': 'SMPH/SURGERY/SURG ONC', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 1/18/2024', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REASSURE Follow Up care', 'interventionNames': ['Other: REASSURE']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Follow Up Care'}], 'interventions': [{'name': 'REASSURE', 'type': 'OTHER', 'description': "REASSURE is comprised of three components that are intended to be integrated into survivorship care at each follow-up visit: 1) An online patient-reported outcome (PRO) assessment to comprehensively evaluate survivors' symptoms and concerns; 2) A tailored follow-up recommendation based on pre-established thresholds for reported symptoms and concerns. Survivors who report symptoms or concerns have a follow-up visit to discuss findings whereas survivors without symptoms or concerns will avoid a follow-up visit; and 3) Online survivorship messaging sent after the visit, which includes reassurance about the low recurrence risk, an overview of what to expect from follow-up, and steps survivors can take to reduce cancer risk.", 'armGroupLabels': ['REASSURE Follow Up care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW Health Oncology Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Heather Neuman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}