Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-26 @ 5:45 PM
Study NCT ID:
NCT04480203
Status:
RECRUITING
Last Update Posted:
2022-03-02
First Post:
2020-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the staff that have contact with the participants will know who receives which intervention. The statistician and investigators will be masked.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An intervention study of breast cancer patients with two digital intervention arms and one control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-11', 'studyFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'change from CABC baseline (week 0) to f-up week 21', 'description': 'Cohens perceived stress scale. Unit is summary score.'}], 'secondaryOutcomes': [{'measure': 'Subjective health (HRQoL)', 'timeFrame': 'change from CABC baseline (week 0) to f-up week 21', 'description': 'RAND-36 questionnaire. Unit is summary score and module-specific scores'}, {'measure': 'Coping', 'timeFrame': 'change from CABC baseline (week 0) to f-up week 21', 'description': 'TOMCATS questionnaire. Unit is summary score.'}, {'measure': 'Anxiety and depression', 'timeFrame': 'change from CABC baseline (week 0) to f-up week 21', 'description': 'PHQ-4 questionnaire. Unit is summary score.'}, {'measure': 'Fatigue', 'timeFrame': 'change from CABC baseline (week 0) to f-up week 21', 'description': "Chalders' fatigue questionnaire. Unit is summary score."}, {'measure': 'Mindfulness', 'timeFrame': 'change from CABC baseline (week 0) to f-up week 21', 'description': 'Baer 2006 mindfulness questionnaire. Unit is summary score.'}, {'measure': 'Sleep', 'timeFrame': 'change from CABC baseline (week 0) to f-up week 21', 'description': 'selected questions fro SUSSH questionnaire. Unit is summary score.'}, {'measure': 'EORTC QLQ-C30', 'timeFrame': 'From NBCR baseline to f-up week 20', 'description': 'EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.'}, {'measure': 'EORTC QLQ-BR23', 'timeFrame': 'From NBCR baseline to f-up week 20', 'description': 'EORTC breast cancer questionnaire. Unit is summary score.'}, {'measure': 'Neuropathy (FACT GOG-NTX and -ES)', 'timeFrame': 'From NBCR baseline to f-up week 20', 'description': 'neuropathy questionnaire. Unit is summary score.'}, {'measure': 'Stress', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 15', 'description': 'Cohens perceived stress scale. Unit is summary score.'}, {'measure': 'Subjective health (HRQoL)', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 15', 'description': 'RAND-36 questionnaire. Unit is summary score and module-specific scores'}, {'measure': 'Coping', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 15', 'description': 'TOMCATS questionnaire. Unit is summary score.'}, {'measure': 'Fatigue', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 15', 'description': "Chalders' fatigue questionnaire. Unit is summary score."}, {'measure': 'Mindfulness', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 15', 'description': 'Baer 2006 mindfulness questionnaire. Unit is summary score.'}, {'measure': 'Anxiety and depression', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 15', 'description': 'PHQ-4 questionnaire. Unit is summary score.'}, {'measure': 'Sleep', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 15', 'description': 'selected questions fro SUSSH questionnaire. Unit is summary score.'}, {'measure': 'Work', 'timeFrame': 'status at f-up month 15', 'description': 'questions on employment. Whether employed and percentage'}, {'measure': 'Stress', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 27', 'description': 'Cohens perceived stress scale. Unit is summary score.'}, {'measure': 'Subjective health (HRQoL)', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 27', 'description': 'RAND-36 questionnaire. Unit is summary score and module-specific scores'}, {'measure': 'Coping', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 27', 'description': 'TOMCATS questionnaire. Unit is summary score.'}, {'measure': 'Anxiety and depression', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 27', 'description': 'PHQ-4 questionnaire. Unit is summary score.'}, {'measure': 'Fatigue', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 27', 'description': "Chalders' fatigue questionnaire. Unit is summary score."}, {'measure': 'Mindfulness', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 27', 'description': 'Baer 2006 mindfulness questionnaire. Unit is summary score.'}, {'measure': 'Sleep', 'timeFrame': 'change from CABC baseline (week 0) to f-up month 27', 'description': 'selected questions fro SUSSH questionnaire. Unit is summary score.'}, {'measure': 'EORTC QLQ-C30', 'timeFrame': 'change from NBCR baseline to f-up month 27', 'description': 'EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.'}, {'measure': 'EORTC QLQ-BR23', 'timeFrame': 'change from NBCR baseline to f-up month 27', 'description': 'EORTC breast cancer questionnaire. Unit is summary score.'}, {'measure': 'Neuropathy (FACT GOG-NTX and -ES)', 'timeFrame': 'From NBCR baseline to f-up month 27', 'description': 'neuropathy questionnaire. Unit is summary score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Related Quality of Life', 'Stress management intervention'], 'conditions': ['Breast Cancer Patients', 'Health, Subjective']}, 'referencesModule': {'references': [{'pmid': '41198868', 'type': 'DERIVED', 'citation': 'Svendsen K, Nes LS, Leithe S, Meland A, Gjelsvik YM, Borosund E, Larsson IM, Myklebust TA, Balto A, Rygg CM, Kiserud CE, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Testing two digital stress-management interventions in a randomized controlled trial of breast cancer patients. Sci Rep. 2025 Nov 6;15(1):38966. doi: 10.1038/s41598-025-22889-0.'}, {'pmid': '37103493', 'type': 'DERIVED', 'citation': 'Svendsen K, Nes LS, Meland A, Larsson IM, Gjelsvik YM, Borosund E, Rygg CM, Myklebust TA, Reinertsen KV, Kiserud CE, Skjerven H, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions. JMIR Res Protoc. 2023 May 24;12:e47195. doi: 10.2196/47195.'}]}, 'descriptionModule': {'briefSummary': '1. Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL.\n2. Among responding breast cancer patients, a subset are invited in a randomized clinical trial with two digital interventions for cancer stress management, cognitive based stress management (CBSM) and mindfulness based intervention (MBI), as well as a control group.\n3. The goal is to determine whether digital CBSM or MBI can effectively reduce stress levels as compared to a control group. Second, whether these interventions can improve HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a control group.', 'detailedDescription': 'After completing the baseline HRQoL assessment, eligible breast cancer patients will be invited to participate in a randomized clinical trial.\n\nThose who are willing will be randomly allocated to one of the following arms: a) Digital cognitive based stress management, b) Digital mindfulness based intervention or c) Control group.\n\nThe intervention is based on a revised version of the Stressproffen app, which was developed by the Oslo University Hospital (Lise Solberg Nes, Elin Børøsund and others).\n\nOutcome measures include measures of perceived stress and HRQoL.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Female breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first occurrence breast cancer diagnosed from Jan 1, 2020\n* non-metastatic cancer stage 0-III\n\nInvasive tumors must be:\n\n* HER2 positive (regardless of ER, PR) or\n* ER negative\n* (may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04480203', 'acronym': 'CABC', 'briefTitle': 'Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Norwegian Institute of Public Health'}, 'officialTitle': 'Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB', 'orgStudyIdInfo': {'id': 'CABC - Kreftfor project - SEB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive based stress management (CBSM)', 'description': 'Cognitive based digital intervention.', 'interventionNames': ['Other: Stressproffen cognitive based stress management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness based intervention (MBI)', 'description': 'Mindfulness based digital intervention.', 'interventionNames': ['Other: Stressproffen mindfulness based intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control arm. No intervention.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Stressproffen cognitive based stress management', 'type': 'OTHER', 'otherNames': ['CBSM'], 'description': 'The participants will download an app (Stressproffen 2A) with cognitive based stress management.', 'armGroupLabels': ['Cognitive based stress management (CBSM)']}, {'name': 'Stressproffen mindfulness based intervention', 'type': 'OTHER', 'otherNames': ['MBI'], 'description': 'The participants will download an app (Stressproffen 2B) with mindfulness based intervention.', 'armGroupLabels': ['Mindfulness based intervention (MBI)']}, {'name': 'Control', 'type': 'OTHER', 'description': 'The participants will receive no app. (They will be able to download it after the end of the 3 year study).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0379', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Giske Ursin', 'role': 'CONTACT', 'email': 'giske.ursin@kreftregisteret.no', 'phone': '+47 22928701'}, {'name': 'Ine Marie Larsson', 'role': 'CONTACT', 'email': 'ine.marie.larsson@kreftregisteret.no', 'phone': '+4722928985'}], 'facility': 'Cancer Registry of Norway', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Giske Ursin, MD, PhD', 'role': 'CONTACT', 'email': 'giske.ursin@kreftregisteret.no', 'phone': '+4722451300'}, {'name': 'Ine M Larsson', 'role': 'CONTACT', 'email': 'ine.marie.larsson@kreftregisteret.no', 'phone': '+4722928985'}], 'overallOfficials': [{'name': 'Giske Ursin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian Institute of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}