Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
Study NCT ID:
NCT04537195
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2020-08-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Lay-led Anxiety and Depression Self-management Program for Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors will be blinded at 7-month follow-up when administering the Hamilton rating scales (secondary outcomes). Participants will be instructed not to disclose their group allocation until the interview is completed'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 234}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depressive Symptoms', 'timeFrame': 'Baseline and 3 months post-intervention', 'description': 'Beck Depression Inventory (BDI-II)'}, {'measure': 'Change in Anxiety Symptoms', 'timeFrame': 'Baseline and 3 months post-intervention', 'description': 'Spielberger State-Trait Inventory (STAI). State subscale.'}], 'secondaryOutcomes': [{'measure': 'Change in Anxiety Symptoms', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Spielberger State-Trait Inventory (STAI). State subscale.'}, {'measure': 'Change in Depressive Symptoms', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Beck Depression Inventory (BDI-II)'}, {'measure': 'Change in Anxiety (observer-rated)', 'timeFrame': 'Baseline and 7 months post-intervention', 'description': 'Hamilton Anxiety Rating Scale (HAM-A6)'}, {'measure': 'Change in Depression (observer-rated)', 'timeFrame': 'Baseline and 7 months post-intervention', 'description': 'Hamilton Depression Rating Scale (HAM-D6)'}, {'measure': 'Change in Fear of cancer recurrence', 'timeFrame': 'Baseline and 3 months post-intervention', 'description': 'Concerns About Recurrence Questionaire (CARQ-4)'}, {'measure': 'Change in Self-efficacy - Personal control', 'timeFrame': 'Baseline and 3 months post-intervention', 'description': 'The Revised Illness Perception Questionnaire (IPQ-R). Personal Control subscale.'}, {'measure': 'Change in Self-efficacy - Social support', 'timeFrame': 'Baseline, and 3 months post-intervention', 'description': 'Obtain Help from Community, Family, Friends Scale (SECD-Ssup)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intervention', 'RCT'], 'conditions': ['Neoplasms', 'Anxiety', 'Self Efficacy', 'Psychological Distress', 'Cancer', 'Distress, Emotional', 'Depression', 'Group, Peer']}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate a peer-to-peer patient self-management program targeting symptoms of anxiety and depression in a randomized trial. A total of 234 cancer patients recently having completed primary treatment with curative intent in central Region Denmark will be included. The intervention is a lay-led, group-based transdiagnostic patient education program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression. The intervention is highly structured and manualized.', 'detailedDescription': 'Recent evidence suggest that transdiagnostic interventions may be just as effective as traditional diagnosis specific interventions when treating symptoms of depression and anxiety. Brief lay-led transdiagnostic self-management interventions may therefore offer an efficient alternative to traditional symptom specific interventions (e.g. CBT) when targeting symptoms of depression and anxiety in cancer.\n\nThe present study aim to evaluate The Anxiety and Depression Symptom Management Program (ADSMP) in a cancer setting (ADSMP-C). The ADSMP is a Danish adaptation of The Stanford University Chronic Disease Self-Management Program (CDSMP) and is developed by the Danish Health Information Committee (In Danish: Komiteen for Sundhedsoplysning in collaboration with The Expert Patient Program Community Interest Company (EPPCIC), the English Health Service (NHS) and Stanford University.\n\nThe ADSMP-C is a lay-led, group-based transdiagnostic patient education program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression concluded with a networking session. The intervention is highly structured and manualized. Sub-group analyses on participants with a history of cancer in a larger trial of ADSMP conducted by members of the study group on behalf of the Danish National Board of Health showed promising results. However, a larger study is needed to establish sound scientific evidence on the effectiveness of the program in a cancer setting.\n\nA total 234 cancer patients recently having completed primary treatment with curative intent in central Region Denmark will be randomized (2:1) to ADSMP-C or a control arm respectively. As a part of the recruitment procedure patients will be screened with The "Distress-Thermometer" at the departments of oncology at the two largest hospitals in Central Region, Denmark following primary treatment or at a follow-up (\\< 1yrs. after primary treatment).\n\nParticipants completes online questionnaires (REDCap) at baseline (pre-randomization), at post-intervention, and at three (primary follow-up) and six months post-intervention, including the Beck\'s Depression Inventory (BDI-II) and Spielbergers State-Trait Anxiety Inventory (STAI-state) (primary outcomes). In addition, all participants will be interviewed at 7 month post-intervention. Outcome assessors, blind to group allocation, will perform observer-based Hamilton A6 and D6 short-form ratings at the interview (secondary outcomes).\n\nData will be evaluated by mixed-effects regression analyses (intention-to-treat).\n\nThe current study will be the first to evaluate the efficacy of ADSMP in a cancer setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated in Central Region Denmark\n* Recently completed (\\< 1 yr.) primary treatment for cancer with curative intent\n* BDI-II score \\>=14 and/or STAI-state score \\>=40\n\nExclusion Criteria:\n\n* Not sufficient Danish language skills to fill Questionnaires and participate in a group based intervention\n* Psychosis\n* Aggressive behavior\n* Imminent suicidal risk'}, 'identificationModule': {'nctId': 'NCT04537195', 'acronym': 'ADSMP-C', 'briefTitle': 'Effects of a Lay-led Anxiety and Depression Self-management Program for Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects on Anxiety and Depression of a Lay-led Transdiagnostic Self-management Program (ADSMP-C) for Patients Recently Treated for Cancer With Curative Intent: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '124941, TrygFonden'}, 'secondaryIdInfos': [{'id': '2016-051-000001, ID 1174', 'type': 'OTHER', 'domain': 'Aarhus University, Denmark'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'ADSMP-C', 'interventionNames': ['Behavioral: ADSMP-C']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Wait-list control group'}], 'interventions': [{'name': 'ADSMP-C', 'type': 'BEHAVIORAL', 'description': 'A transdiagnostic, lay-led, group-based self-management program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression in cancer (ADSMP-C)', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Dep. Oncology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Dep. Oncology, Regional Hospital West Jutland', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Soren Christensen, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. Psychology, Aarhus University, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At the present the policy of Aarhus University does not allow the sharing of data according to GDPR rules. However this policy may be subject to change'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}, {'name': 'Komiteen for Sundhedsoplysning', 'class': 'UNKNOWN'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}