Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT02949167
Status:
UNKNOWN
Last Update Posted:
2021-08-31
First Post:
2016-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MyHealth: Follow-up After Breast Cancer Treatment
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 503}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health Care Use', 'timeFrame': 'at 60 months', 'description': 'Study specific items on health care use single items'}], 'primaryOutcomes': [{'measure': 'Changes in breast cancer specific symptom burden (TOI-PFB)', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score of the Functional Assessment of Cancer Therapy -Breast (FACT-B) Domains: Physical well-being, Functional wellbeing,BC symptoms'}], 'secondaryOutcomes': [{'measure': 'Changes in breast cancer specific symptom burden', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'Functional Assessment of Cancer Therapy -Breast (FACT-B) Domains: Physical well-being, social/family well-being, Emotional well-being,Functional wellbeing, BC symptoms'}, {'measure': 'Changes in knowledge, skill, and confidence for self-management', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'Patient Activation Measure (PAM)'}, {'measure': 'Changes in anxiety', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'Generalized Anxiety Disorder (GAD-7)'}, {'measure': 'Changes in self-management', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'The Health Education Impact Questionnaire (heiQ)'}, {'measure': 'Changes in fear of recurrence', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'Concerns About Recurrence Questionnaire (CARQ-4)'}, {'measure': 'Changes in Depression', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'The Patient Health Questionnaire (PHQ-9)'}, {'measure': 'Changes in work ability', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'Work Ability Index (WAI)'}, {'measure': 'Changes in quality-adjusted life year (QALY)', 'timeFrame': 'at inclusion, 6 months,12 months, 24 months, 36 months and 60 months', 'description': 'EuroQol 5 domains (5D), 5 levels (5L)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nurse-led follow-up after breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '38498781', 'type': 'DERIVED', 'citation': 'Saltbaek L, Bidstrup PE, Karlsen RV, Hoeg BL, Horsboel TA, Belmonte F, Andersen EAW, Zoffmann V, Friberg AS, Svendsen MN, Christensen HG, Glavicic V, Nielsen DL, Dalton SO, Johansen C. Nurse-Led Individualized Follow-Up Versus Regular Physician-Led Visits After Early Breast Cancer (MyHealth): A Phase III Randomized, Controlled Trial. J Clin Oncol. 2024 Jun 10;42(17):2038-2049. doi: 10.1200/JCO.23.01447. Epub 2024 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'Approximately 24,000 women attend a follow-up care program after end of primary treatment for breast cancer (BC) in Denmark. There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program (MyHealth) will significantly reduce reported symptoms among BC patients following primary treatment compared to physician-led scheduled follow-up. Secondary, the investigators will examine patient activation (self-management), anxiety, depression, fear of recurrence, work ability, time to recurrence, overall survival, health behavior changes, health care utilization and financial costs in the two arms.\n\nThe MyHealth program provides patients with a nurse-led education focusing on management of symptoms, an electronic platform to report symptoms to the nurses and support in symptom management and navigation of patients to appropriate health care services.', 'detailedDescription': 'During an 18-month period, 494 primary BC patients will be recruited from the Departments of Oncology at Naestved and Roskilde Hospital. The women will be enrolled in the study following completion of primary treatment. Participants are randomized 1:1 to the intervention (Nurse-led follow up) or control group (physician-led follow-up) and followed for 5 years. No matter group assignment, all women will follow the national mammography screening programs.\n\nPatients who accept to participate are asked to invite a close relative, preferably partners, to participate in the study. Patients, who do not want to participate in the randomization will be asked if they are willing to participate in the study by filling out two questionnaires. Patients who decline to participate in the MyHealth study will be enrolled in the standard follow-up.\n\nThe investigators will collect data using questionnaires, clinical databases, and national registers before intervention and for 5 years after inclusion both in the control and intervention arm. Questionnaires from validated scales are used to measure primary and secondary outcomes in both groups whereas Patient Reported Outcomes (PRO) are only collected in the intervention group. Patients who experiences relapse during the MyHealth intervention will not be asked to fill in the remaining outcome questionnaires or PROs since they quit the follow-up program in favor of treatment for recurrent disease.\n\nDuring follow-up, the patient will consult the nurse or the project physician if PROs reveal a need, or if the patient require a consultation. In order to ensure that treatment of symptoms and referral to other health professionals will meet clinical guidelines the nurses are instructed to follow a detailed response algorithm, which is developed by the project physician in collaboration with experienced oncologists.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complete remission following primary treatment for loco-regional BC (stage I-II) - No confirmed genetic predisposition to BC\n* Female gender\n* Performance status ≤3\n* Read, understand and speak Danish\n* No severe cognitive problems\n* No severe psychiatric disease requiring treatment or any substance abuse.\n\nExclusion Criteria:\n\n* Genetic predisposition for BC\n* Patient younger than 40 years of age at diagnosis\n* Control after recurrent breast cancer\n* Other active cancer except non-melanoma skin cancer\n* Severe cognitive problems or dementia\n* Severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence'}, 'identificationModule': {'nctId': 'NCT02949167', 'acronym': 'MyHealth', 'briefTitle': 'MyHealth: Follow-up After Breast Cancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Danish Cancer Society'}, 'officialTitle': 'MyHealth: Nurse-led Compared to Physician-led Breast Cancer Follow-up: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Record.12714019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MyHealth intervention arm', 'description': 'Nurse-led follow-up', 'interventionNames': ['Behavioral: MyHealth']}, {'type': 'NO_INTERVENTION', 'label': 'MyHealth Control condition', 'description': 'Physician-led follow-up'}], 'interventions': [{'name': 'MyHealth', 'type': 'BEHAVIORAL', 'description': 'The MyHealth intervention is a nurse-led individually tailored symptom management program, focused on patient education and regularly collection of Patient Reported Outcomes (PRO) subsequently evaluated by specialist nurses and navigation to health care service. The nurse will meet with the patient on three-five planned appointments focused on adjustment of life after breast cancer treatment including information on symptoms of relapse or late effects and how to react on these. Close relatives are invited if patients accept. Patients will report PRO´s on symptoms of recurrence and late effects every three months during the first year and thereafter every six months.The appointments with the nurse are finalized within 3-6 month and patients will be followed with PRO for three years.', 'armGroupLabels': ['MyHealth intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4700', 'city': 'Næstved', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Department of Oncology and Palliative Care, Naestved Hospital', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}], 'overallOfficials': [{'name': 'Christoffer Johansen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cancer Society Research Center, Survivorship'}, {'name': 'Mads N Svendsen, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Department for Oncology Naestved and Roskilde Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Cancer Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Sjælland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christoffer Johansen', 'investigatorAffiliation': 'Danish Cancer Society'}}}}