Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 3:59 AM
Study NCT ID:
NCT05603234
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2022-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptom Monitoring and Menopausal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-14', 'size': 1997704, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-10-10T08:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Menopausal symptom changes via the Daily Record Keeping (DRK) form', 'timeFrame': 'at baseline and after 2 weeks of symptom monitoring', 'description': 'Changes in menopausal symptom scores after 2-weeks of symptom monitoring, where reductions in symptoms would suggest a beneficial outcomes.'}, {'measure': 'Emotional outcomes via the Daily Record Keeping (DRK) form', 'timeFrame': 'at baseline and after 2 weeks of symptom monitoring', 'description': 'Changes in emotion scores after 2-weeks of symptom monitoring. The DRK assesses emotional outcomes via specific emotion subscales including Negative Emotions, Positive affect, Anxiety, Depression, Loneliness. Reductions in Negative Emotions, Anxiety, Loneliness, Depression after 2-weeks would suggest benefical effects, as would increases in Positive Affect.'}], 'secondaryOutcomes': [{'measure': 'Help seeking intentions', 'timeFrame': 'at baseline and after 2 weeks of symptom monitoring', 'description': 'Changes in Help Seeking Intention scores as assessed via the General Help Seeking Questionnaire (GHSQ). Increases in GHSQ scores at 2-weeks would indicate benefical effects on help seeking behaviour.'}, {'measure': 'General Self Efficacy', 'timeFrame': 'at baseline and after 2 weeks of symptom monitoring', 'description': 'Changes in General Self Efficacy scores as assessed via the General Self Efficacy (GSE) scale. Increases in GSE scores at 2-weeks would indicate beneficial effects on self efficacy.'}, {'measure': 'Decision making efficacy', 'timeFrame': 'at baseline after 2 weeks of symptom monitoring', 'description': 'Changes in Decision making efficacy scores as assessed via the Decision Self Efficacy (DSE) scale. Increases in DSE scores after 2-weeks would suggest benefical effects on medical decision making.'}, {'measure': 'Health communication', 'timeFrame': 'at baseline after 2 weeks of symptom monitoring', 'description': 'Changes in Health communication scores as assessed via the Willingness to Communicate about Health (WTCH) questionnaire. Increases in WTCH scores after 2-weeks would suggest benefical effects on health communication.'}, {'measure': 'Health Anxiety', 'timeFrame': 'at baseline and after 2 weeks of symptom monitoring', 'description': 'Changes in Health Anxiety scores as assessed via the Health Orientation Scale (HOS). Reductions in Health Anxiety after 2-weeks would suggest beneficial effects.'}, {'measure': 'Health Consciousness', 'timeFrame': 'at baseline and after 2 weeks of symptom monitoring', 'description': 'Changes in Health Consciousness scores as assessed via the HOS. Reductions in Health Consciousness scores after 2-weeks would suggest beneficial effects.'}, {'measure': 'Coping preference', 'timeFrame': 'Measured at baseline to assess whether coping preference moderated symptom monitoring outcomes', 'description': "Monitoring/ Blunting Coping preference assessed via the Miller's Behavioural Style Scale (MBSS). The MBSS score can be used in analyses as a continuous variable, with individuals displaying more or less monitoring coping characteristics. Scores range from 0 (no monitoring characteristics) to 72 (high monitoring characteristics)."}, {'measure': 'Trait neuroticism', 'timeFrame': 'Measured at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes', 'description': 'Trait neuroticism was assessed via the IPIP-NEO 10-item neuroticism subscale. This scale ranges from 10 (low trait neuroticism) to 50 (high trait neuroticism).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Menopause', 'Hot flushes', "Women's Health", 'Symptom Monitoring'], 'conditions': ['Menopause']}, 'referencesModule': {'references': [{'pmid': '34927137', 'type': 'BACKGROUND', 'citation': 'Andrews R, Hale G, John B, Lancastle D. Evaluating the Effects of Symptom Monitoring on Menopausal Health Outcomes: A Systematic Review and Meta-Analysis. Front Glob Womens Health. 2021 Dec 3;2:757706. doi: 10.3389/fgwh.2021.757706. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviours. To date, no studies have experimentally investigated whether symptom monitoring could be beneficial as an intervention for menopausal women.\n\nOne hundred menopausal women were randomised into either a Monitoring-intervention or Control group. A mixed between/ within design was employed, with group membership (i.e., Monitoring-intervention or Control) as the between-subjects component, and time (i.e., baseline and 2-weeks follow-up) as the within-subjects component. Dependent variables included symptom reductions and emotional reactions. Secondary outcomes included help-seeking, communication, medical decision-making, health awareness, self-efficacy, and health anxiety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participants must be women experiencing self-reported menopause/ perimenopause', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Women\n* Aged 18+\n* Reporting at least 2 menopausal hot flushes per day\n* Self-reported peri- or post-menopausal status.\n\nExclusion criteria:\n\n* Male\n* Under age 18\n* Reported fewer than 2 hot flushes per day\n* Does not self-report peri- or post-menopausal status.'}, 'identificationModule': {'nctId': 'NCT05603234', 'briefTitle': 'Symptom Monitoring and Menopausal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of South Wales'}, 'officialTitle': 'Evaluating the Effects of Symptom Monitoring on Physical & Emotional Outcomes During Menopause: A Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '21059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symptom Monitoring Intervention', 'description': 'This group reported their symptoms every day for 14 days.', 'interventionNames': ['Behavioral: Symptom Monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group did not monitor their symptoms every day for the 14 day period, however they did report their symptoms at the beginning and end of the 14 day period'}], 'interventions': [{'name': 'Symptom Monitoring', 'type': 'BEHAVIORAL', 'description': 'Reporting symptoms each day via a symptom questionnaire', 'armGroupLabels': ['Symptom Monitoring Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF371DL', 'city': 'Treforest', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'University of South Wales', 'geoPoint': {'lat': 51.59353, 'lon': -3.32474}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Wales', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}