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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
This project will develop and test the optimal combination a home-based, low-burden chrono-behavioral therapy (ChronoBT) targeting these zeitgebers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition A: light/dark, eating and activity | Experimental | Condition A: light/dark, eating and activity: Bright 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. |
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| Condition B: Light/dark and eating | Experimental | Condition B: Light/dark and eating: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime and eating within a 10-hour window. |
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| Condition C: Light/dark and activity | Experimental | Condition C: Light/dark and activity: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime and taking a 15 minutes daily walk. |
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| Condition D: Eating and activity | Experimental | Condition D: Eating and activity: Eating within a 10-hour window and taking a 15 minutes daily walk. |
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| Condition E: Light/dark | Experimental | Condition E: Light/dark: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronotherapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related Fatigue | 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. | T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Sleep quality by the Pittsburg Sleep Quality Index (PSQI), measuring seven domains. Higher score indicates worse sleep. | T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence and fidelity | Start/end times of component(s) and protocol deviations by personal logs | During the intervention period: One week for WP1, and four weeks for WP2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa M Wu, PhD | Contact | +45 87153748 | lisa.wu@psy.au.dk | |
| Louise Strøm, PhD | Contact | +45 87165076 | louisestroem@oncology.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lisa M Wu, PhD | University of Aarhus | Principal Investigator |
| Ali Amidi, PhD | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University and Aarhus University Hospital | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D019454 | Chronotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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).
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The researcher in charge of the randomization is masked.
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| Condition F: Eating | Experimental | Condition F: Eating: Eating within a 10-hour window |
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| Condition G: Activity | Experimental | Condition G: Activity: Taking a15 minutes daily walk. |
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| Condition H: Circadian watch | Active Comparator | Condition H: Circadian watch: Waring a circadian watch to access circadian activity |
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| Control | Behavioral | Control condition |
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| Insomnia |
Insomnia by the Insomnia Severity Index (ISI). Number of items: 7. Score range: 0-28. Higher score indicate worse insomnia. |
| T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion) |
| Anxiety and Depression | 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. | T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion) |
| Health-related Quality of Life | 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. | T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion) |
| Cognition | 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. | T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion) |
| Circadian Function | Circadian Function Index derived from actigraphy data. Score range: 0-1. Higher score indicate more robust rhythms. | During the entire period of intervention and follow-up T4 (4 weeks post intervention completion) |
| Chronotype | 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. | T1 (Baseline) |
| Credibility/Expectancy | Credibility/Expectancy by the Credibility/Expectancy Questionnaire (CEQ). Number of items: 6. Item score range: 1-9. Higher score indicates more credibility/expectancy. | T1 (Baseline) |
| Treatment Satisfaction | Treatment Satisfaction by the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G). Number of items: 8. Score range: 0-21. Higher score indicates better satisfaction. | T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion) |