Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-03 @ 11:28 AM
Study NCT ID:
NCT03939156
Status:
UNKNOWN
Last Update Posted:
2023-06-28
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of risk reduction needed to consider endocrine therapy worthwhile', 'timeFrame': '1 week', 'description': 'Risk reduction will be evaluated in the 40% and 20% 5 years risk scenarios'}, {'measure': 'Number of years gain needed to consider ET worthwhile', 'timeFrame': '1 week', 'description': 'Prolonged survival time gain will be evaluated in the 5-yr and 15-yr survival scenarios'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adjuvant endocrine therapy', "patient's preferences"], 'conditions': ['Breast Cancer', 'Endocrine Breast Diseases']}, 'descriptionModule': {'briefSummary': 'Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile.\n\nThey are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment.\n\nPreviously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile.\n\nLarger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile.', 'detailedDescription': "The endocrine therapy is generally proposed to all patients with endocrine positive early breast cancer to reduce the risk of recurrence and death. Moreover several data support that the prolongation of hormonal therapy (i.e. 10 years of hormonal treatment) is associated with statistical improved outcome.\n\nIn order to achieve the benefit related to hormonal therapy all women have to be treated despite the fact that the data and analyses are unable to differentiate as to whether a small prolongation in survival accrues to all women treated or a few patients survive who would otherwise have died. Moreover the hormonal therapy is associated with side effects that may impact the quality of life of the patients.\n\nPatients are more likely to accept treatment on the basis of presented relative rather than absolute risks and so the question arises as to whether unrealistic improvements in outcome are expected by patients.\n\nThe interviews with patients in the proposed trial will elicit the expected gains both in terms of survival and life years and will be able to assess the proportion of patients who considered an improvement of realistic size was sufficient to justify the treatment and the prolongation of the treatment.\n\nSeveral studies showed that choices are guided by the personal attitude to react and adapt to traumatic events, individual resilience.\n\nIt is important therefore to consider also the influence of these factors on the patients' treatment preferences.\n\nFor this reason, besides the elicitation of preferences, resilience and reaction to traumatic events will be assessed thorough validated questionnaires."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hormonal receptors positive breast cancer candidate to adjuvant hormonal therapy or who are receiving hormonal therapy (within 1 year from beginning for group 2 and who are received at least 4 or 5 or 6 years of hormonal therapy)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women candidate to adjuvant hormonal therapy for breast cancer before the start of therapy\n* Women who are receiving hormonal therapy (within 1 year from beginning)\n* Women who are receiving hormonal therapy (who had receive at least 4 or 5 or 6 years of hormonal therapy)\n* Patients who underwent to radical surgery for breast cancer\n* Patients who have received neoadjuvant or adjuvant chemotherapy are also eligible\n* Hormonal receptors positive breast cancer (ER and or PgR \\>1%)\n* Sufficient literacy in Italian to complete the questionnaires.\n\nExclusion Criteria:\n\n* Patients who had received at least 1 year and no more than 3 years of hormonal therapy\n* Patients who are receiving hormonal therapy (who had receive 7 years or more of hormonal therapy)'}, 'identificationModule': {'nctId': 'NCT03939156', 'acronym': 'ELENA', 'briefTitle': "Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer", 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': "Evaluation of Endocrine Therapy and Patients Preferences in Early Breast Cancer - Patients' Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer.", 'orgStudyIdInfo': {'id': 'IEO 0837/'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 - before starting ET', 'description': 'women candidate to receive ET and interviewed before starting treatment', 'interventionNames': ['Other: Completion of questionnaires']}, {'label': 'Group 2 - within 1 year of ET', 'description': 'women interviewed within 1 years from beginning of ET', 'interventionNames': ['Other: Completion of questionnaires']}, {'label': 'Group 3 - between 4 and 6 years of ET', 'description': 'women interviewed after more than 4 years but no more than 6 years of ET', 'interventionNames': ['Other: Completion of questionnaires']}], 'interventions': [{'name': 'Completion of questionnaires', 'type': 'OTHER', 'description': 'Completion of questionnaires at the time of study entry', 'armGroupLabels': ['Group 1 - before starting ET', 'Group 2 - within 1 year of ET', 'Group 3 - between 4 and 6 years of ET']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Emilia Montagna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}