An interventional study of Chronotherapy and Control in Chronic Fatigue and Cancer Survivors, sponsored by Aarhus University Hospital. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment
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.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's planned enrollment of 200 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Chronotherapy
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.
Behavioral: Chronotherapy
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.
Behavioral: Chronotherapy
Condition D: Eating and activity: Eating within a 10-hour window and taking a 15 minutes daily walk.
Behavioral: Chronotherapy
Condition E: Light/dark: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime
Behavioral: Chronotherapy
Condition F: Eating: Eating within a 10-hour window
Behavioral: Chronotherapy
Condition G: Activity: Taking a15 minutes daily walk.
Behavioral: Chronotherapy
Condition H: Circadian watch: Waring a circadian watch to access circadian activity
Behavioral: Control
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.
Control condition
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.
Time frame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
Sleep Quality
Sleep quality by the Pittsburg Sleep Quality Index (PSQI), measuring seven domains. Higher score indicates worse sleep.
Time frame: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
Insomnia
Insomnia by the Insomnia Severity Index (ISI). Number of items: 7. Score range: 0-28. Higher score indicate worse insomnia.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
Adherence and fidelity
Start/end times of component(s) and protocol deviations by personal logs
Time frame: During the intervention period: One week for WP1, and four weeks for WP2
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Aarhus University Hospital