Chrono-behavioral Therapy for Chronic Fatigue in Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chronotherapy, Control.
- Who it may be relevant to
- Registry conditions: Chronic Fatigue, Cancer Survivors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Chronotherapy
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. - Behavioral Control
Control condition
Primary outcome measures
- 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)]
Secondary outcome measures (9)
- 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)]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus University and Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT06845267 · ChronoBT