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The main purpose of this interdisciplinary proposal is to conduct two randomized controlled trial (RCT) of the efficacy of self-administered systematic light exposure (Bright White Light (BWL)), an innovative, low cost, and low burden intervention to treat cancer-related fatigue. Another common and often overlapping treatment side-effect is cognitive impairment. A secondary outcome of the proposed RCT is, thus, cognitive functioning. Finally, possible underlying chronobiological (circadian activity rhythms, sleep), biological (pro inflammatory markers), and neurophysiological (brain morphology) mechanisms of BWL will be explored.
Two independent but similar RCTs with a total of 144 breast cancer patients (Group 1 = 72 high risk patients; Group 2 = 72 low risk breast cancer patients) post-treatment screened for fatigue will be randomized to BWL (36 in each of the two groups) or dim light(DL) (36 in each of the two groups) exposure for 30 minutes/morning for 4 weeks, and assessed before, during, immediately and 3 months after the intervention. Measures include questionnaires, cognitive assessment, actigraphy, blood samples, saliva samples, and magnetic resonance imaging (MRI).
1.1 Aims and hypotheses. Aim 1: To test the efficacy of BWL on fatigue (primary outcome) in breast cancer patients.
Hypothesis 1: Compared with control participants exposed to DL, participants randomized to BWL will report less fatigue immediately and 3 months after the intervention.
Aim 2: To test the efficacy of BWL on cognitive functioning (secondary outcome).
Hypothesis 2: Compared with controls, BWL recipients will show improved cognitive functioning immediately and 3 months after the intervention.
Aim 3: To explore the effects of BWL on chronobiological, biological, and neurophysiological markers.
Hypothesis 3: BWL will be associated with normalized circadian activity rhythms (3a); improved sleep (3b); decreased inflammation (3c); increased cortical and subcortical grey matter density (3d); and increased cortical and subcortical white matter integrity (3e). If hypotheses 1 and/or 2 are confirmed, the mediating effects of the markers will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systematic bright light exposure | Experimental | Systematic bright light exposure for 30 min. for 4 weeks |
|
| Systematic dim light exposure | Active Comparator | Systematic dim light exposure for 30 min. for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Litebook | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related fatigue (FACIT-fatigue) | Changes in fatigue from baseline to immediately after intervention (T1-T2) | |
| Cancer-related fatigue (FACIT-fatigue) | Changes in fatigue from baseline to 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | Immediately after intervention and 3 months after intervention | |
| Beck's Depression Inventory - II (BDI-II) | Immediately after intervention and 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mediators: Changes in brain white mater diffusion integrity as measured with diffusion-weighted MR imaging: Diffusion/kurtosis parameters. | Immediately after intervention | |
| Mediators: Changes in Pro-inflammatory cytokines (Il-1, Il-6, Tnf-alpha) (blood draw) | Changes from baseline to immediately after intervention |
Inclusion Criteria - Group 1:
Exclusion Criteria:
Inclusion criteria - Group 2:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitets Hospital | Aarhus | 8000 | Denmark |
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| Connors Continous performance test (CPT-3) | Immediately after intervention |
| Psychomotor vigilance test (PVT) | Immediately after intervention |
| Hopkins Verbal Learning Test (HVLT-R) | Immediately after intervention |
| Health-related quality of life (SF-36) | Immediately after intervention and 3 months after intervention |
| Anxiety symptoms (HADS Anxiety) | Immediately after intervention and 3 months after intervention |
| Impact of events (IES-R) | Immediately after intervention and 3 months after intervention |
| Patients assessment of own functioning Inventory (POAFI) | Immediately after intervention and 3 months after intervention |
| Overall neuropsychological composite score | Immediately after intervention and 3 months after intervention |
| Mediators: Changes in circadian activity rhythms (actigraphy) | Changes from baseline to immediately after intervention |
| Mediators: Changes in diurnal Cortisol (saliva samples) | From baseline to immediately after intervention |
| Mediators: Changes in diurnal melatonin (as measured with saliva samples) | From baseline to immediately after intervention |
| Mediators: Changes in grey matter density as measured by T-1 weighted MR imaging (voxel-based morphometry) | Immediately after intervention |