Chrono-behavioral Therapy for Chronic Fatigue in Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Chronotherapy
BehavioralThis 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
BehavioralControl condition
Treatment groups
200 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Condition A: light/dark, eating and activityExperimental treatment 1 intervention
Group B: Condition B: Light/dark and eatingExperimental treatment 1 intervention
Group C: Condition C: Light/dark and activityExperimental treatment 1 intervention
Group D: Condition D: Eating and activityExperimental treatment 1 intervention
Group E: Condition E: Light/darkExperimental treatment 1 intervention
Group F: Condition F: EatingExperimental treatment 1 intervention
Group G: Condition G: ActivityExperimental treatment 1 intervention
Group H: Condition H: Circadian watchActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
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 WP2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aarhus University Hospital
Lead sponsor
University of Aarhus
Sponsor institution
University of Aarhus
Collaborator
Source ClinicalTrials.gov
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