Chronic FatigueChronoBTNCT06845267
Chrono-behavioral Therapy for Chronic Fatigue in Cancer
A study testing Chronotherapy in people with Chronic Fatigue and Cancer Survivors, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Fatigue, Cancer Survivors
- What is being tested?
- Chronotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prostate or female breast cancer survivors
- completed local and/or adjuvant cancer therapy (with the exception of hormonal therapy) ≥ 1 year previously
- ≥18 years of age
- able to speak and read Danish
- experiencing CRF (score ≤36 on FACT-F)
Who cannot join
- use of light therapy in the last year
- 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)
- non-cancer related factor likely to be a driver of fatigue (e.g., shift work, pregnancy, recent travel across time zones)
- recurrence of cancer or new cancer
- physical or psychological conditions that could prevent participation in intervention components
- use of photosensitizing medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Aarhus University and Aarhus University Hospital
Aarhus, 8000
Lisa M Wu, PhD, +45 87153748, lisa.wu@psy.au.dk
Louise Strøm, PhD, +45 87165076, louisestroem@oncology.au.dk
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Fatigue, Cancer Survivors
- Being tested
- Chronotherapy, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChronotherapyBehavioural
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.
ControlBehavioural
Control condition
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Chronotherapy |
| 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. Receives: Behavioral: Chronotherapy |
| 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. Receives: Behavioral: Chronotherapy |
| Condition D: Eating and activity | Experimental | Condition D: Eating and activity:
Eating within a 10-hour window and taking a 15 minutes daily walk. Receives: Behavioral: Chronotherapy |
| 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 Receives: Behavioral: Chronotherapy |
| Condition F: Eating | Experimental | Condition F: Eating:
Eating within a 10-hour window Receives: Behavioral: Chronotherapy |
| Condition G: Activity | Experimental | Condition G: Activity:
Taking a15 minutes daily walk. Receives: Behavioral: Chronotherapy |
| Condition H: Circadian watch | Active comparator | Condition H: Circadian watch:
Waring a circadian watch to access circadian activity Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1 (Baseline, pre-intervention), T2 (two weeks post intervention initiation), T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
Secondary outcomes (9)
Sleep Quality
Sleep quality by the Pittsburg Sleep Quality Index (PSQI), measuring seven domains. Higher score indicates worse sleep.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic FatigueStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Lisa Maria Wu, University of Aarhus
- Investigators
- Lisa M Wu, PhD, Principal investigator, University of AarhusAli Amidi, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845267
- Sponsor's protocol ID
- ChronoBT
- Acronym
- ChronoBT
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chrono-behavioral Therapy for Chronic Fatigue in Cancer
- ClinicalTrials.gov ID
- NCT06845267
- Acronym / sponsor ID
- ChronoBT / ChronoBT
- Conditions
- Chronic Fatigue, Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Condition A: light/dark, eating and activity | Experimental | Behavioral: ChronotherapyCondition 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. |
| Condition B: Light/dark and eating | Experimental | Behavioral: ChronotherapyCondition 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. |
| Condition C: Light/dark and activity | Experimental | Behavioral: ChronotherapyCondition 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. |
| Condition D: Eating and activity | Experimental | Behavioral: ChronotherapyCondition D: Eating and activity: Eating within a 10-hour window and taking a 15 minutes daily walk. |
| Condition E: Light/dark | Experimental | Behavioral: ChronotherapyCondition E: Light/dark: Bright white light glasses 30 minutes upon awakening and blue light blocking glasses 3 hours before bedtime |
| Condition F: Eating | Experimental | Behavioral: ChronotherapyCondition F: Eating: Eating within a 10-hour window |
| Condition G: Activity | Experimental | Behavioral: ChronotherapyCondition G: Activity: Taking a15 minutes daily walk. |
| Condition H: Circadian watch | Active comparator | Behavioral: ControlCondition H: Circadian watch: Waring a circadian watch to access circadian activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- prostate or female breast cancer survivors
- completed local and/or adjuvant cancer therapy (with the exception of hormonal therapy) ≥ 1 year previously
- ≥18 years of age
- able to speak and read Danish
- experiencing CRF (score ≤36 on FACT-F)
Key exclusion criteria (6 listed)
- use of light therapy in the last year
- 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)
- non-cancer related factor likely to be a driver of fatigue (e.g., shift work, pregnancy, recent travel across time zones)
- recurrence of cancer or new cancer
- physical or psychological conditions that could prevent participation in intervention components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChronotherapyThis 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. | Behavioural | 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 |
| ControlControl condition | Behavioural | Condition H: Circadian watch |
Primary outcome
Cancer-related 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)
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.
9 secondary outcomes
Sleep Quality
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
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
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
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
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
Time frame: During the entire period of intervention and follow-up T4 (4 weeks post intervention completion)
Chronotype
Time frame: T1 (Baseline)
Credibility/Expectancy
Time frame: T1 (Baseline)
Treatment Satisfaction
Time frame: T3 (1 day post intervention completion), T4 (follow-up 4 weeks post intervention completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa M Wu, PhD principal investigator
University of Aarhus
Ali Amidi, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronotherapy in people with Chronic Fatigue and Cancer Survivors, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M Wu, PhD (+45 87153748, lisa.wu@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.