Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-02 @ 8:36 AM
Study NCT ID:
NCT06845267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2025-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chrono-behavioral Therapy for Chronic Fatigue in Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019454', 'term': 'Chronotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The researcher in charge of the randomization is masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible participants will be randomly assigned to one of eight 4-week intervention conditions to test the optimal combination of the three ChronoBT components utilizing a Multiphase Optimization Strategy (MOST).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence and fidelity', 'timeFrame': 'During the intervention period: One week for WP1, and four weeks for WP2', 'description': 'Start/end times of component(s) and protocol deviations by personal logs'}], 'primaryOutcomes': [{'measure': 'Cancer-related Fatigue', 'timeFrame': 'T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)', 'description': 'Cancer-related Fatigue by the Functional Assessment of Cancer Therapy - Fatigue Scale (FACT-F) Number of items: 13. Score range: 0-52. Lower score indicates more fatigue.'}], 'secondaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)', 'description': 'Sleep quality by the Pittsburg Sleep Quality Index (PSQI), measuring seven domains. Higher score indicates worse sleep.'}, {'measure': 'Insomnia', 'timeFrame': 'T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)', 'description': 'Insomnia by the Insomnia Severity Index (ISI). Number of items: 7. Score range: 0-28. Higher score indicate worse insomnia.'}, {'measure': 'Anxiety and Depression', 'timeFrame': 'T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)', 'description': 'Anxiety and Depression by the Hospital Anxiety and Depression Scale (HADS). Number of items: 14. Score range: 0-21 for each domain. Higher score indicates worse symptoms.'}, {'measure': 'Health-related Quality of Life', 'timeFrame': 'T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)', 'description': 'Health-related Quality of Life by the Functional Assessment of Cancer Therapy - General (FACT-G). Number of items: 27. Score range: 0-128. Higher score indicates worse quality of life.'}, {'measure': 'Cognition', 'timeFrame': 'T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)', 'description': 'Quality of Life - Cognition items from the European Organization for Research and Treatment of Cancer Questionnaires (EORTC-QLQ-30). Number of items: 2. Score range: 2-8. Higher score indicate more impairment.'}, {'measure': 'Circadian Function', 'timeFrame': 'During the entire period of intervention and follow-up T4 (4 weeks post intervention completion)', 'description': 'Circadian Function Index derived from actigraphy data. Score range: 0-1. Higher score indicate more robust rhythms.'}, {'measure': 'Chronotype', 'timeFrame': 'T1 (Baseline)', 'description': 'Chronotype by the reduced Morningness-Eveningness Questionnaire (rMEQ). Number of items: 5. Score range 5-25. Higher score indicates closer to morningness type, while lower score indicate closer to eveningness type.'}, {'measure': 'Credibility/Expectancy', 'timeFrame': 'T1 (Baseline)', 'description': 'Credibility/Expectancy by the Credibility/Expectancy Questionnaire (CEQ). Number of items: 6. Item score range: 1-9. Higher score indicates more credibility/expectancy.'}, {'measure': 'Treatment Satisfaction', 'timeFrame': 'T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)', 'description': 'Treatment Satisfaction by the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G).\n\nNumber of items: 8. Score range: 0-21. Higher score indicates better satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Fatigue', 'Cancer Survivors']}, 'descriptionModule': {'briefSummary': 'Cancer-related fatigue (CRF) is a severe and persistent side effect of cancer and its treatment, affecting up to 40% of patients and significantly reducing quality of life. Recent research suggests that circadian rhythm disruption has been implicated as a possible related pathophysiological mechanism underlying CRF. Circadian rhythms are 24-hour cycles regulating physiology and behavior through environmental cues called "zeitgebers." Strengthening these cues-such as light exposure, physical activity, and eating-may help reduce CRF.\n\nThis project will develop and test the optimal combination a home-based, low-burden chrono-behavioral therapy (ChronoBT) targeting these zeitgebers.', 'detailedDescription': 'Cancer-related fatigue (CRF) is frequently reported as the most severe and distressing side effect of cancer and its treatment. Among cancer patients, up to 40% will experience CRF that can last months or even years after treatment and it is also deleterious to quality of life. However, there is still no established CRF treatment. Underlying mechanisms of CRF are likely multi-factorial and recently, circadian rhythm disruption has been implicated as a possible related pathophysiological mechanism underlying CRF. Circadian rhythms are endogenous 24-hour cycles of rhythmicity in physiology and behavior orchestrated by the suprachiasmatic nuclei (SCN) in the brain. They are entrained to the environment via time-giving cues called "zeitgebers". Thus, improving circadian rhythm robustness by strengthening modifiable zeitgebers is one potential way to ameliorate CRF. The overarching goal of the proposed project is to conduct an optimization trial of a home-based, low-burden multicomponent chrono-behavioral therapy (ChronoBT) that aims to strengthen the effects of 3 zeitgebers to treat CRF - light/dark exposure, physical activity and eating - all of which individually have shown promise in strengthening circadian rhythms and reducing fatigue. The study will include two work packages: In Work Package 1 (WP1), the investigators will pilot test candidate intervention components in prostate and female breast cancer survivors. In Work Package 2 (WP2), a fully powered optimization trial will be undertaken using the framework - the Multiphase Optimization Strategy (MOST), to test the optimal combination of ChronoBT components.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. prostate or female breast cancer survivors\n2. completed local and/or adjuvant cancer therapy (with the exception of hormonal therapy) ≥ 1 year previously\n3. ≥18 years of age\n4. able to speak and read Danish\n5. experiencing CRF (score ≤36 on FACT-F)\n\nExclusion Criteria:\n\n1. use of light therapy in the last year\n2. confounding underlying medical/psychiatric disorders or use of medications associated with fatigue (e.g., a central nervous system cancer, untreated hypothyroidism, anemia, chronic fatigue syndrome, insomnia, major depression)\n3. non-cancer related factor likely to be a driver of fatigue (e.g., shift work, pregnancy, recent travel across time zones)\n4. recurrence of cancer or new cancer\n5. physical or psychological conditions that could prevent participation in intervention components\n6. use of photosensitizing medications'}, 'identificationModule': {'nctId': 'NCT06845267', 'acronym': 'ChronoBT', 'briefTitle': 'Chrono-behavioral Therapy for Chronic Fatigue in Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Chrono-behavioral Therapy for Chronic Fatigue in Cancer', 'orgStudyIdInfo': {'id': 'ChronoBT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Condition A: light/dark, eating and activity', 'description': 'Condition A: light/dark, eating and activity:\n\nBright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime; eating within a 10-hour window, and taking a 15 minutes daily walk.', 'interventionNames': ['Behavioral: Chronotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Condition B: Light/dark and eating', 'description': 'Condition B: Light/dark and eating:\n\nBright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime and eating within a 10-hour window.', 'interventionNames': ['Behavioral: Chronotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Condition C: Light/dark and activity', 'description': 'Condition C: Light/dark and activity:\n\nBright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime and taking a 15 minutes daily walk.', 'interventionNames': ['Behavioral: Chronotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Condition D: Eating and activity', 'description': 'Condition D: Eating and activity:\n\nEating within a 10-hour window and taking a 15 minutes daily walk.', 'interventionNames': ['Behavioral: Chronotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Condition E: Light/dark', 'description': 'Condition E: Light/dark:\n\nBright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime', 'interventionNames': ['Behavioral: Chronotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Condition F: Eating', 'description': 'Condition F: Eating:\n\nEating within a 10-hour window', 'interventionNames': ['Behavioral: Chronotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Condition G: Activity', 'description': 'Condition G: Activity:\n\nTaking a15 minutes daily walk.', 'interventionNames': ['Behavioral: Chronotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Condition H: Circadian watch', 'description': 'Condition H: Circadian watch:\n\nWaring a circadian watch to access circadian activity', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Chronotherapy', 'type': 'BEHAVIORAL', 'description': 'This study utilize and test different combinations of three types of interventions (zeitgebers) to entrain the circadian rhythm: 1) Light being the primary photic zeitgebers that directly entrain the SCN, 2) physical activity and 3) timing of eating) being non-photic zeitgebers that drive peripheral rhythms.', 'armGroupLabels': ['Condition A: light/dark, eating and activity', 'Condition B: Light/dark and eating', 'Condition C: Light/dark and activity', 'Condition D: Eating and activity', 'Condition E: Light/dark', 'Condition F: Eating', 'Condition G: Activity']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Control condition', 'armGroupLabels': ['Condition H: Circadian watch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'contacts': [{'name': 'Lisa M Wu, PhD', 'role': 'CONTACT', 'email': 'lisa.wu@psy.au.dk', 'phone': '+45 87153748'}, {'name': 'Louise Strøm, PhD', 'role': 'CONTACT', 'email': 'louisestroem@oncology.au.dk', 'phone': '+45 87165076'}, {'name': 'Lisa M Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aarhus University and Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Lisa M Wu, PhD', 'role': 'CONTACT', 'email': 'lisa.wu@psy.au.dk', 'phone': '+45 87153748'}, {'name': 'Louise Strøm, PhD', 'role': 'CONTACT', 'email': 'louisestroem@oncology.au.dk', 'phone': '+45 87165076'}], 'overallOfficials': [{'name': 'Lisa M Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}, {'name': 'Ali Amidi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lisa Maria Wu', 'investigatorAffiliation': 'University of Aarhus'}}}}