Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 4:59 AM
Study NCT ID:
NCT03980093
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2019-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication adherence assessed by electronic pillbox (Wisepill box)', 'timeFrame': 'Change from baseline through 6 month follow-up'}], 'secondaryOutcomes': [{'measure': 'Self-reported medication adherence', 'timeFrame': 'Change from baseline to 3 and 6 month follow-up', 'description': 'Reported anti-hormonal medication pills missed, past 30 days, with a validated self-reported medication adherence item'}, {'measure': 'Positive and negative emotional associations with taking anti-hormonal medication', 'timeFrame': 'Change from baseline through 6 month follow-up', 'description': 'Emotional Attitudes Scale, adapted to focus on anti-hormonal medication'}, {'measure': 'Intentions to adhere to anti-hormonal medication in the next year and next several years', 'timeFrame': 'Change from baseline through 6 month follow up', 'description': 'Anti-Hormonal Medication Intentions Scale (average score on a 1 to 7 scale; higher=better outcome, e.g., stronger intentions to adhere), adapted from the Health Behavior Intentions Scale'}, {'measure': 'Medication nonpersistence assessed by electronic pillbox (Wisepill box)', 'timeFrame': 'Baseline through 6 month follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This pilot trial compares two online interventions to improve adherence to anti-hormonal medication among women with the most common form of breast cancer (estrogen receptor-positive).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria include:\n\n1. Women in Colorado treated for Stage 0 to III estrogen receptor-positive breast cancer who have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) and within the past 2.5 years, have been prescribed anti-hormonal therapy\n2. Take their anti-hormonal therapy medication at least occasionally and have at least 1 more year left on their prescription\n3. Report at least 1 factor that makes taking their anti-hormonal therapy medication difficult\n4. Have internet access'}, 'identificationModule': {'nctId': 'NCT03980093', 'briefTitle': 'The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Boulder'}, 'officialTitle': 'A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '18-0234'}, 'secondaryIdInfos': [{'id': 'R21CA218723', 'link': 'https://reporter.nih.gov/quickSearch/R21CA218723', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education plus Values', 'interventionNames': ['Behavioral: Education', 'Behavioral: Values']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.', 'armGroupLabels': ['Education', 'Education plus Values']}, {'name': 'Values', 'type': 'BEHAVIORAL', 'description': 'An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.', 'armGroupLabels': ['Education plus Values']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}], 'overallOfficials': [{'name': 'Joanna J Arch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Boulder'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Psychology and Neuroscience', 'investigatorFullName': 'Joanna Arch', 'investigatorAffiliation': 'University of Colorado, Boulder'}}}}